Geriatric Hip FractureNCT05393349
Geriatric Hip Fractures Caregiver Programme
A study testing Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures in people with Geriatric Hip Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Objective: To study whether fracture hip patients can be benefited from the empowerment program Hypothesis to be tested Primary hypothesis: empowerment program can improve the patient's functional recovery. Secondary hypothesis: the program can improve readmission rate, length of stay, and secondary fracture. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Geriatric Hip Fracture
- What is being tested?
- Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteHong Kong
- Study dates
- 5 Sep 2019to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥60
- Acute intracapsular or extracapsular proximal femur fracture
- Surgical treatment: Hemiarthroplasty or reduction-internal fixation
- Availability of caregiver
Who cannot join
- No caregiver support
- Non-operative treatment
- Pathological fracture
- Multiple fractures
- Patient discharged directly from the acute hospital without convalescence 6. Premorbid bedbound/chairbound status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 'Home Sweet Home' Programme: Empowering the Patient and Caregiver for Early and Safe Discharge of Patients With Geriatric Hip Fractures
Objective:
To study whether fracture hip patients can be benefited from the empowerment program
Read more
Hypothesis to be tested Primary hypothesis: empowerment program can improve the patient's functional recovery.
Secondary hypothesis: the program can improve readmission rate, length of stay, and secondary fracture.
Design and subjects This is a prospective randomised controlled trial and subjects are fracture hip patients
Instruments Ipads are needed to show the videos of the rehabilitation program
Interventions
The empowerment program consists of three main areas which directly correspond to the contents that the patients and caregivers expressed as most needed in interviews conducted by the investigators during hip fracture patients' follow up:
- Knowledge of the disease
- Confidence and skills in self-care management
- Support in the post-discharge period
Main outcome measures
Primary outcomes:
Functional scores (Modified Barthel Index and EQ-5D-5L) at the first follow-up visit (3 months postop).
Timed-up-and-go test at follow-up at 6 months and 1 year.
Secondary outcome:
Cumulative readmission rates at 1 month, 6 months, and 1 year The length of stay in the convalescent hospital Subsequent injury with fractures within 1 year
Data analysis Chi-square test is used for categorical variables. For continuous variables, the normal distribution is determined by the Kolmogorov-Smirnov test. Independent t-test is used for comparing average values of normally distributed continuous variables, while the Wilcoxon rank sum test is used for comparing median values of abnormally distributed variables.
Binary logistic regression is used to determine predictive factors for outcomes. Multivariate analysis is performed to verify independent predictive factors for outcomes.
Expected results Fracture hip patients can be benefited from the empowerment program.
Read the detailed description
Introduction:
Health care consequences of hip fracture The global incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years. Local data showed that there was a steady increase from 3500 to more than 4500 hip fractures per year from 2000 to 2011. Nevertheless, the consequence of hip fractures is serious and costly. Ten percent of patients have a contralateral hip fracture, 30% of the patients are readmitted for other acute reasons, 25% need long-term care, 10-25% die within 1 year and almost 50% have residual functional disabilities.
Geriatric hip fracture clinical pathway decreased preoperative length of stay Since 2006, the geriatric hip fracture clinical pathway (GFH) has been implemented in the Hong Kong West Cluster. The implementation of GFH resulted in a decreased preoperative length of stay, decreased surgical site infection, decreased pressure sore, and decreased 30-day and 12-month mortality rate.
High dependency of patients upon discharge:
However, according to our data, a significant number of patients still required an extended length of stay, which is defined as more than 28 days in a rehabilitation hospital. More than 60% of the patients were discharged home, however, 39% and 51% of the patients had severe and moderate dependency respectively upon discharge from the rehabilitation hospital (Modified Barthel Index 0-60 and 61-90 respectively). Current training provided to those patients and their caregivers was brief and inadequate. The lack of a trained caregiver affects the decision to return home and patients may need settlement in nursing homes. Moreover, 12% had readmission within 28 days of discharge, with repeated falls accounting for the majority.
The patients were referred to a geriatric day hospital after discharge from the convalescent hospital. However, the waiting time for geriatric day hospital was 2 months. During this interval, the patients were discharged home and taken care of by the caregivers. The caregivers were unsupported and inadequately trained for the job.
Patient and caregiver empowerment for hip fracture patients in Hong Kong:
Patient empowerment has been used in patients with stroke and other geriatric conditions. There are only scarce studies focussing on geriatric hip fractures which required special care in terms of ambulation, transfers, and activities of daily living training. So far prospective randomized studies are lacking. A previous study showed patient empowerment resulted in a shortened length of stay and earlier return to previous living by comparing two hospitals.
In Hong Kong, the elderly hip fracture patients returning home are often taken care of by domestic helpers or family members. Caring for older patients after hospital discharge is challenging and many of their caregivers lack the confidence to do so. Hence, we opine that caregivers need special attention as well. Another study also studied the caregivers' burden of hip fracture patients in Taiwan. The caregivers experienced moderate burdens. Caregivers who could not access other resources for help experienced a higher burden.
There has been an increasing trend for patient and caregiver empowerment programs. A study done by Hendrix (2013) investigated the effects of an individualized caregiver training program on self-efficacy in-home care and symptom management. Results revealed a significant increase in self-efficacy after the training in the treatment group, however, their study focused on cancer patients only. Another study done by Coleman in the year 2004 tested whether an intervention designed to encourage older patients and their caregivers to assert a more active role during discharge could result in decreased rehospitalization rates. He showed the adjusted odds ratio comparing rehospitalization of intervention subjects with that of controls was 0.52 at 30 days, 0.43 at 90 days, and 0.57 at 180 days. Intervention patients reported high levels of confidence in obtaining essential information for managing their condition, communicating with members of the healthcare team, and understanding their medication regimen. Their patient population is heterogeneous and includes various medical and orthopaedic patients.
Most studies on patient and caregiver empowerment had shown positive results. The proposed study focuses on empowering hip fracture patients and their caregivers in all aspects in terms of ambulation, transfers, and activities of daily living training. The impact of empowerment on hip fracture patients and their caregivers has not been studied in Hong Kong and the aim of the project is to investigate if those fracture hip patients can be benefited from the empowerment program in terms of functional outcomes.
- Conditions
- Geriatric Hip Fracture
- Being tested
- Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures
- Keywords
- Empowerment, Caregiver, Geriatric Hip Fractures, Functional outcomes
- Medical subject headings
- Empowerment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fracturesBehavioural
Orthopaedic surgeon, geriatrician, physiotherapists, occupational therapists, and nurses will make videos (each 3-5 minutes long) which are available to the patients and caregivers during both the hospitalization period and after discharge. They will complement the therapists' training sessions and allow revision of the contents by the patients and caregivers anytime. The patients and caregivers will be asked to complete an assessment after they view the videos to reinforce the knowledge they learn in the videos. Caregivers can be patient's relatives, friends or domestic helper who can commit to visiting the patient at least two days per week during the early discharge period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Not described Receives: Behavioral: Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures |
| Standard Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Scores - Modified Barthel Index (MBI)
The Modified Barthel Index (MBI) is an ordinal scale, often referred to as a 0-100 point total score or 0-100 point scale, used to quantify a patient's level of independence in activities of daily living (ADL). 0 indicates total dependence and 100 indicates total independence.
Measured: 2 months follow-up
Functional Scores - Modified Barthel Index (MBI)
The Modified Barthel Index (MBI) is an ordinal scale, often referred to as a 0-100 point total score or 0-100 point scale, used to quantify a patient's level of independence in activities of daily living (ADL). 0 indicates total dependence and 100 indicates total independence.
Measured: 6 months follow-up
Functional Scores - Modified Barthel Index (MBI)
The Modified Barthel Index (MBI) is an ordinal scale, often referred to as a 0-100 point total score or 0-100 point scale, used to quantify a patient's level of independence in activities of daily living (ADL). 0 indicates total dependence and 100 indicates total independence.
Measured: 12 months follow-up
Functional Scores - EQ5D-Utility-Index
It is a widely used, generic, preference-based measure of health-related quality of life (HRQoL) representing societal preferences. It calculates a single summary utility score from five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Typically ranges between 0 (dead) and 1 (full health).
Measured: 2 months follow-up
Functional Scores - EQ5D-Utility-Index
It is a widely used, generic, preference-based measure of health-related quality of life (HRQoL) representing societal preferences. It calculates a single summary utility score from five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Typically ranges between 0 (dead) and 1 (full health).
Measured: 6 months follow-up
Functional Scores - EQ5D-Utility-Index
It is a widely used, generic, preference-based measure of health-related quality of life (HRQoL) representing societal preferences. It calculates a single summary utility score from five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Typically ranges between 0 (dead) and 1 (full health).
Measured: 12 months follow-up
Functional Scores - EQ-QOL-VAS Value
EuroQoL Visual Analog Scale (EQ-VAS ) is a quantitative, self-reported measure of an individual's overall health-related quality of life, ranging from 0 to 100. It complements the EQ-5D descriptive system by providing a direct, subjective rating of "today's" health status, where 0 represents the worst imaginable health and 100 represents the best imaginable health. It reflects the patient's own perspective, rather than the general population's preferences (which are used for EQ-5D index values).
Measured: 2 months follow-up
Functional Scores - EQ-QOL-VAS Value
EuroQoL Visual Analog Scale (EQ-VAS ) is a quantitative, self-reported measure of an individual's overall health-related quality of life, ranging from 0 to 100. It complements the EQ-5D descriptive system by providing a direct, subjective rating of "today's" health status, where 0 represents the worst imaginable health and 100 represents the best imaginable health. It reflects the patient's own perspective, rather than the general population's preferences (which are used for EQ-5D index values).
Measured: 6 months follow-up
Functional Scores - EQ-QOL-VAS Value
EuroQoL Visual Analog Scale (EQ-VAS ) is a quantitative, self-reported measure of an individual's overall health-related quality of life, ranging from 0 to 100. It complements the EQ-5D descriptive system by providing a direct, subjective rating of "today's" health status, where 0 represents the worst imaginable health and 100 represents the best imaginable health. It reflects the patient's own perspective, rather than the general population's preferences (which are used for EQ-5D index values).
Measured: 12 months follow-up
Functional Scores - EQ5D-5L Mobility
The EQ-5D-5L mobility dimension measures mobility using five levels: no problems, slight, moderate, severe, and unable to walk, providing high sensitivity. Mobility, often along with pain/discomfort, shows the highest health impairment, ranging from 1 to 5.
Level 1 (No problem to walk) Level 2 (Slight problem to walk) Level 3 (Moderate problem to walk) Level 4 (Severe problem to walk) Level 5 (Unable to walk)
Measured: 2 months follow-up
Functional Scores - EQ5D-5L Mobility
The EQ-5D-5L mobility dimension measures mobility using five levels: no problems, slight, moderate, severe, and unable to walk, providing high sensitivity. Mobility, often along with pain/discomfort, shows the highest health impairment, ranging from 1 to 5.
Level 1 (No problem to walk) Level 2 (Slight problem to walk) Level 3 (Moderate problem to walk) Level 4 (Severe problem to walk) Level 5 (Unable to walk)
Measured: 6 months follow-up
Functional Scores - EQ5D-5L Mobility
The EQ-5D-5L mobility dimension measures mobility using five levels: no problems, slight, moderate, severe, and unable to walk, providing high sensitivity. Mobility, often along with pain/discomfort, shows the highest health impairment, ranging from 1 to 5.
Level 1 (No problem to walk) Level 2 (Slight problem to walk) Level 3 (Moderate problem to walk) Level 4 (Severe problem to walk) Level 5 (Unable to walk)
Measured: 12 months follow-up
Functional Scores - EQ5D-5L-SELF-CARE
The EQ-5D-5L self-care dimension assesses a respondent's ability to wash or dress themselves, ranging from no problems to extreme inability. It features five severity levels to capture subtle changes in functioning, which measures the impact of health conditions on daily, personal care activities.
Level 1 (I have no problems with self-care (e.g., washing or dressing)) Level 2 (I have slight problems with self-care) Level 3 (I have moderate problems with self-care) Level 4 (I have severe problems with self-care) Level 5 (I am unable to wash or dress myself (extreme problem))
Measured: 2 months follow-up
Functional Scores - EQ5D-5L-SELF-CARE
The EQ-5D-5L self-care dimension assesses a respondent's ability to wash or dress themselves, ranging from no problems to extreme inability. It features five severity levels to capture subtle changes in functioning, which measures the impact of health conditions on daily, personal care activities.
Level 1 (I have no problems with self-care (e.g., washing or dressing)) Level 2 (I have slight problems with self-care) Level 3 (I have moderate problems with self-care) Level 4 (I have severe problems with self-care) Level 5 (I am unable to wash or dress myself (extreme problem))
Measured: 6 months follow-up
Functional Scores - EQ5D-5L-SELF-CARE
The EQ-5D-5L self-care dimension assesses a respondent's ability to wash or dress themselves, ranging from no problems to extreme inability. It features five severity levels to capture subtle changes in functioning, which measures the impact of health conditions on daily, personal care activities.
Level 1 (I have no problems with self-care (e.g., washing or dressing)) Level 2 (I have slight problems with self-care) Level 3 (I have moderate problems with self-care) Level 4 (I have severe problems with self-care) Level 5 (I am unable to wash or dress myself (extreme problem))
Measured: 12 months follow-up
Functional Scores - EQ5D-5L-USUAL-ACTIVITIES
The EQ-5D-5L Usual Activities dimension assesses how health problems affect a person's ability to perform daily tasks like work, study, housework, family, or leisure activities. Respondents choose one of five severity levels (no, slight, moderate, severe, or unable) based on their capacity to perform these functions today.
Level 1 (No Problems: I have no problems doing my usual activities) Level 2 (Slight Problems: I have slight problems doing my usual activities) Level 3 (Moderate Problems: I have moderate problems doing my usual activities) Level 4 (Severe Problems: I have severe problems doing my usual activities) Level 5 (Unable: I am unable to do my usual activities)
Measured: 2 months follow-up
Functional Scores - EQ5D-5L-USUAL-ACTIVITIES
The EQ-5D-5L Usual Activities dimension assesses how health problems affect a person's ability to perform daily tasks like work, study, housework, family, or leisure activities. Respondents choose one of five severity levels (no, slight, moderate, severe, or unable) based on their capacity to perform these functions today.
Level 1 (No Problems: I have no problems doing my usual activities) Level 2 (Slight Problems: I have slight problems doing my usual activities) Level 3 (Moderate Problems: I have moderate problems doing my usual activities) Level 4 (Severe Problems: I have severe problems doing my usual activities) Level 5 (Unable: I am unable to do my usual activities)
Measured: 6 months follow-up
Functional Scores - EQ5D-5L-USUAL-ACTIVITIES
The EQ-5D-5L Usual Activities dimension assesses how health problems affect a person's ability to perform daily tasks like work, study, housework, family, or leisure activities. Respondents choose one of five severity levels (no, slight, moderate, severe, or unable) based on their capacity to perform these functions today.
Level 1 (No Problems: I have no problems doing my usual activities) Level 2 (Slight Problems: I have slight problems doing my usual activities) Level 3 (Moderate Problems: I have moderate problems doing my usual activities) Level 4 (Severe Problems: I have severe problems doing my usual activities) Level 5 (Unable: I am unable to do my usual activities)
Measured: 12 months follow-up
Functional Scores - EQ5D-5L-PAIN/DISCOMFORT
The EQ-5D-5L Pain/Discomfort dimension assesses the severity of pain and physical discomfort across five levels, ranging from no problems to extreme problems. It measures how often or intensely a patient experiences pain, itching, or other physical sensations (excluding mental distress), providing a 5-level, more sensitive scale than the 3L version.
Level 1 (I have no pain or discomfort) Level 2 (I have slight pain or discomfort) Level 3 (I have moderate pain or discomfort) Level 4 (I have severe pain or discomfort) Level 5 (I have extreme pain or discomfort)
Measured: 2 months follow-up
Functional Scores - EQ5D-5L-PAIN/DISCOMFORT
The EQ-5D-5L Pain/Discomfort dimension assesses the severity of pain and physical discomfort across five levels, ranging from no problems to extreme problems. It measures how often or intensely a patient experiences pain, itching, or other physical sensations (excluding mental distress), providing a 5-level, more sensitive scale than the 3L version.
Level 1 (I have no pain or discomfort) Level 2 (I have slight pain or discomfort) Level 3 (I have moderate pain or discomfort) Level 4 (I have severe pain or discomfort) Level 5 (I have extreme pain or discomfort)
Measured: 6 months follow-up
Functional Scores - EQ5D-5L-PAIN/DISCOMFORT
The EQ-5D-5L Pain/Discomfort dimension assesses the severity of pain and physical discomfort across five levels, ranging from no problems to extreme problems. It measures how often or intensely a patient experiences pain, itching, or other physical sensations (excluding mental distress), providing a 5-level, more sensitive scale than the 3L version.
Level 1 (I have no pain or discomfort) Level 2 (I have slight pain or discomfort) Level 3 (I have moderate pain or discomfort) Level 4 (I have severe pain or discomfort) Level 5 (I have extreme pain or discomfort)
Measured: 12 months follow-up
Functional Scores - EQ5D-5L ANXIETY/DEPRESSION
The EQ5D-5L Anxiety/Depression dimension assesses the emotional/psychological component of health-related quality of life. It is often used to determine if mental health symptoms amplify reported physical health issues. It measures self-reported levels of anxiety and depression in five severity levels.
Level 1 (I am not anxious or depressed) Level 2 (I am slightly anxious or depressed) Level 3 (I am moderately anxious or depressed) Level 4 (I am severely anxious or depressed) Level 5 (I am extremely anxious or depressed)
Measured: 2 months follow-up
Functional Scores - EQ5D-5L ANXIETY/DEPRESSION
The EQ5D-5L Anxiety/Depression dimension assesses the emotional/psychological component of health-related quality of life. It is often used to determine if mental health symptoms amplify reported physical health issues. It measures self-reported levels of anxiety and depression in five severity levels.
Level 1 (I am not anxious or depressed) Level 2 (I am slightly anxious or depressed) Level 3 (I am moderately anxious or depressed) Level 4 (I am severely anxious or depressed) Level 5 (I am extremely anxious or depressed)
Measured: 6 months follow-up
Functional Scores - EQ5D-5L ANXIETY/DEPRESSION
The EQ5D-5L Anxiety/Depression dimension assesses the emotional/psychological component of health-related quality of life. It is often used to determine if mental health symptoms amplify reported physical health issues. It measures self-reported levels of anxiety and depression in five severity levels.
Level 1 (I am not anxious or depressed) Level 2 (I am slightly anxious or depressed) Level 3 (I am moderately anxious or depressed) Level 4 (I am severely anxious or depressed) Level 5 (I am extremely anxious or depressed)
Measured: 12 months follow-up
Walking Function - Timed-Up-and-Go (TUG)
The Timed-Up-and-Go (TUG) test is a quick, 3-meter walk assessment measuring functional mobility, balance, and fall risk in older adults. Patient starts seated, wearing regular footwear and using their usual walking aid (if needed). Then, the patient rises from a chair, walks 3 meters at a normal pace, turns, walks back, and sits down. Times less than or equivalent to 12 seconds indicate normal, while times greater than or equivalent to 20 seconds signify high fall risk.
Scoring and Interpretation < 10 seconds (Normal) < 20 seconds (Independent and generally considered within normal limits for frail elderly) > 20 seconds (Limited functional independence; high fall risk) > 30 seconds (High risk of falling, often requiring assistance)
Measured: 2 months follow-up
Walking Function - Timed-Up-and-Go (TUG)
The Timed-Up-and-Go (TUG) test is a quick, 3-meter walk assessment measuring functional mobility, balance, and fall risk in older adults. Patient starts seated, wearing regular footwear and using their usual walking aid (if needed). Then, the patient rises from a chair, walks 3 meters at a normal pace, turns, walks back, and sits down. Times less than or equivalent to 12 seconds indicate normal, while times greater than or equivalent to 20 seconds signify high fall risk.
Scoring and Interpretation < 10 seconds (Normal) < 20 seconds (Independent and generally considered within normal limits for frail elderly) > 20 seconds (Limited functional independence; high fall risk) > 30 seconds (High risk of falling, often requiring assistance)
Measured: 6 months follow-up
Walking Function - Timed-Up-and-Go (TUG)
The Timed-Up-and-Go (TUG) test is a quick, 3-meter walk assessment measuring functional mobility, balance, and fall risk in older adults. Patient starts seated, wearing regular footwear and using their usual walking aid (if needed). Then, the patient rises from a chair, walks 3 meters at a normal pace, turns, walks back, and sits down. Times less than or equivalent to 12 seconds indicate normal, while times greater than or equivalent to 20 seconds signify high fall risk.
Scoring and Interpretation < 10 seconds (Normal) < 20 seconds (Independent and generally considered within normal limits for frail elderly) > 20 seconds (Limited functional independence; high fall risk) > 30 seconds (High risk of falling, often requiring assistance)
Measured: 12 months follow-up
Secondary outcomes (8)
Survival Rate
The count of participants confirmed to be living upon cross-referencing with the mortality registry at the six-month mark.
Measured: 6 months
Survival Rate
The count of participants confirmed to be living upon cross-referencing with the mortality registry at the twelve-months (or one-year) mark.
Measured: 12 months
Survival Rate
The count of participants confirmed to be living upon cross-referencing with the mortality registry at 24 months (or 2 years) mark.
Measured: 24 months
Number of Subsequent Fracture
The number of participants with second fracture in 12 months (or 1 year) time
Measured: Within 12 months (1 year)
Second Admission Rate
The number of participants with a second hospital stay within the same 12-month timeframe (or 1 year).
Measured: Within 12 months (1 year)
Usage of Walking Aids
Number of participants using different ambulatory support levels or walking aids at 2 months post-intervention (e.g., unaided, stick, quadripod, walking frame, requiring human assistance, and non-walker).
Measured: At 2 months
Usage of Walking Aids
Number of participants using different ambulatory support levels or walking aids at 6 months post-intervention (e.g., unaided, stick, quadripod, walking frame, requiring human assistance, and non-walker).
Measured: At 6 months
Usage of Walking Aids
Number of participants using different ambulatory support levels or walking aids at 12 months post-intervention (e.g., unaided, stick, quadripod, walking frame, requiring human assistance, and non-walker).
Measured: At 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start5 Sep 2019
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Geriatric Hip FractureStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Wong Tak-Man, The University of Hong Kong
- Investigators
- Tak Man Wong, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05393349
- Sponsor's protocol ID
- UW 19-574
- Status last verified
- Jun 2026
- First submitted
- 26 Apr 2022
- Last updated
- 23 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 'Home Sweet Home' Programme: Empowering the Patient and Caregiver for Early and Safe Discharge of Patients With Geriatric Hip Fractures
- ClinicalTrials.gov ID
- NCT05393349
- Acronym / sponsor ID
- UW 19-574
- Conditions
- Geriatric Hip Fracture
- Keywords
- Empowerment, Caregiver, Geriatric Hip Fractures, Functional outcomes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- 5 Sep 2019 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 26 May 2022 (actual)
- Results
- Posted 23 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective:
To study whether fracture hip patients can be benefited from the empowerment program
Hypothesis to be tested Primary hypothesis: empowerment program can improve the patient's functional recovery.
Secondary hypothesis: the program can improve readmission rate, length of stay, and secondary fracture.
Design and subjects This is a prospective randomised controlled trial and subjects are fracture hip patients
Instruments Ipads are needed to show the videos of the rehabilitation program
Interventions
The empowerment program consists of three main areas which directly correspond to the contents that the patients and caregivers expressed as most needed in interviews conducted by the investigators during hip fracture patients' follow up:
- Knowledge of the disease
- Confidence and skills in self-care management
- Support in the post-discharge period
Main outcome measures
Primary outcomes:
Functional scores (Modified Barthel Index and EQ-5D-5L) at the first follow-up visit (3 months postop).
Timed-up-and-go test at follow-up at 6 months and 1 year.
Secondary outcome:
Cumulative readmission rates at 1 month, 6 months, and 1 year The length of stay in the convalescent hospital Subsequent injury with fractures within 1 year
Data analysis Chi-square test is used for categorical variables. For continuous variables, the normal distribution is determined by the Kolmogorov-Smirnov test. Independent t-test is used for comparing average values of normally distributed continuous variables, while the Wilcoxon rank sum test is used for comparing median values of abnormally distributed variables.
Binary logistic regression is used to determine predictive factors for outcomes. Multivariate analysis is performed to verify independent predictive factors for outcomes.
Expected results Fracture hip patients can be benefited from the empowerment program.
Detailed description
Introduction:
Health care consequences of hip fracture The global incidence of geriatric hip fractures is projected to increase by more than 250% in the next twenty-five years. Local data showed that there was a steady increase from 3500 to more than 4500 hip fractures per year from 2000 to 2011. Nevertheless, the consequence of hip fractures is serious and costly. Ten percent of patients have a contralateral hip fracture, 30% of the patients are readmitted for other acute reasons, 25% need long-term care, 10-25% die within 1 year and almost 50% have residual functional disabilities.
Geriatric hip fracture clinical pathway decreased preoperative length of stay Since 2006, the geriatric hip fracture clinical pathway (GFH) has been implemented in the Hong Kong West Cluster. The implementation of GFH resulted in a decreased preoperative length of stay, decreased surgical site infection, decreased pressure sore, and decreased 30-day and 12-month mortality rate.
High dependency of patients upon discharge:
However, according to our data, a significant number of patients still required an extended length of stay, which is defined as more than 28 days in a rehabilitation hospital. More than 60% of the patients were discharged home, however, 39% and 51% of the patients had severe and moderate dependency respectively upon discharge from the rehabilitation hospital (Modified Barthel Index 0-60 and 61-90 respectively). Current training provided to those patients and their caregivers was brief and inadequate. The lack of a trained caregiver affects the decision to return home and patients may need settlement in nursing homes. Moreover, 12% had readmission within 28 days of discharge, with repeated falls accounting for the majority.
The patients were referred to a geriatric day hospital after discharge from the convalescent hospital. However, the waiting time for geriatric day hospital was 2 months. During this interval, the patients were discharged home and taken care of by the caregivers. The caregivers were unsupported and inadequately trained for the job.
Patient and caregiver empowerment for hip fracture patients in Hong Kong:
Patient empowerment has been used in patients with stroke and other geriatric conditions. There are only scarce studies focussing on geriatric hip fractures which required special care in terms of ambulation, transfers, and activities of daily living training. So far prospective randomized studies are lacking. A previous study showed patient empowerment resulted in a shortened length of stay and earlier return to previous living by comparing two hospitals.
In Hong Kong, the elderly hip fracture patients returning home are often taken care of by domestic helpers or family members. Caring for older patients after hospital discharge is challenging and many of their caregivers lack the confidence to do so. Hence, we opine that caregivers need special attention as well. Another study also studied the caregivers' burden of hip fracture patients in Taiwan. The caregivers experienced moderate burdens. Caregivers who could not access other resources for help experienced a higher burden.
There has been an increasing trend for patient and caregiver empowerment programs. A study done by Hendrix (2013) investigated the effects of an individualized caregiver training program on self-efficacy in-home care and symptom management. Results revealed a significant increase in self-efficacy after the training in the treatment group, however, their study focused on cancer patients only. Another study done by Coleman in the year 2004 tested whether an intervention designed to encourage older patients and their caregivers to assert a more active role during discharge could result in decreased rehospitalization rates. He showed the adjusted odds ratio comparing rehospitalization of intervention subjects with that of controls was 0.52 at 30 days, 0.43 at 90 days, and 0.57 at 180 days. Intervention patients reported high levels of confidence in obtaining essential information for managing their condition, communicating with members of the healthcare team, and understanding their medication regimen. Their patient population is heterogeneous and includes various medical and orthopaedic patients.
Most studies on patient and caregiver empowerment had shown positive results. The proposed study focuses on empowering hip fracture patients and their caregivers in all aspects in terms of ambulation, transfers, and activities of daily living training. The impact of empowerment on hip fracture patients and their caregivers has not been studied in Hong Kong and the aim of the project is to investigate if those fracture hip patients can be benefited from the empowerment program in terms of functional outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures |
| Standard Group | No intervention | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥60
- Acute intracapsular or extracapsular proximal femur fracture
- Surgical treatment: Hemiarthroplasty or reduction-internal fixation
- Availability of caregiver
Key exclusion criteria (5 listed)
- No caregiver support
- Non-operative treatment
- Pathological fracture
- Multiple fractures
- Patient discharged directly from the acute hospital without convalescence 6. Premorbid bedbound/chairbound status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fracturesOrthopaedic surgeon, geriatrician, physiotherapists, occupational therapists, and nurses will make videos (each 3-5 minutes long) which are available to the patients and caregivers during both the hospitalization period and after discharge. They will complement the therapists' training sessions and allow revision of the contents by the patients and caregivers anytime. The patients and caregivers will be asked to complete an assessment after they view the videos to reinforce the knowledge they learn in the videos. Caregivers can be patient's relatives, friends or domestic helper who can commit to visiting the patient at least two days per week during the early discharge period. | Behavioural | Intervention Group |
Primary outcome
Functional Scores - Modified Barthel Index (MBI)
Time frame: 2 months follow-up
The Modified Barthel Index (MBI) is an ordinal scale, often referred to as a 0-100 point total score or 0-100 point scale, used to quantify a patient's level of independence in activities of daily living (ADL). 0 indicates total dependence and 100 indicates total independence.
Functional Scores - Modified Barthel Index (MBI)
Time frame: 6 months follow-up
The Modified Barthel Index (MBI) is an ordinal scale, often referred to as a 0-100 point total score or 0-100 point scale, used to quantify a patient's level of independence in activities of daily living (ADL). 0 indicates total dependence and 100 indicates total independence.
Functional Scores - Modified Barthel Index (MBI)
Time frame: 12 months follow-up
The Modified Barthel Index (MBI) is an ordinal scale, often referred to as a 0-100 point total score or 0-100 point scale, used to quantify a patient's level of independence in activities of daily living (ADL). 0 indicates total dependence and 100 indicates total independence.
Functional Scores - EQ5D-Utility-Index
Time frame: 2 months follow-up
It is a widely used, generic, preference-based measure of health-related quality of life (HRQoL) representing societal preferences. It calculates a single summary utility score from five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Typically ranges between 0 (dead) and 1 (full health).
Functional Scores - EQ5D-Utility-Index
Time frame: 6 months follow-up
It is a widely used, generic, preference-based measure of health-related quality of life (HRQoL) representing societal preferences. It calculates a single summary utility score from five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Typically ranges between 0 (dead) and 1 (full health).
Functional Scores - EQ5D-Utility-Index
Time frame: 12 months follow-up
It is a widely used, generic, preference-based measure of health-related quality of life (HRQoL) representing societal preferences. It calculates a single summary utility score from five health dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). Typically ranges between 0 (dead) and 1 (full health).
Functional Scores - EQ-QOL-VAS Value
Time frame: 2 months follow-up
EuroQoL Visual Analog Scale (EQ-VAS ) is a quantitative, self-reported measure of an individual's overall health-related quality of life, ranging from 0 to 100. It complements the EQ-5D descriptive system by providing a direct, subjective rating of "today's" health status, where 0 represents the worst imaginable health and 100 represents the best imaginable health. It reflects the patient's own perspective, rather than the general population's preferences (which are used for EQ-5D index values).
Functional Scores - EQ-QOL-VAS Value
Time frame: 6 months follow-up
EuroQoL Visual Analog Scale (EQ-VAS ) is a quantitative, self-reported measure of an individual's overall health-related quality of life, ranging from 0 to 100. It complements the EQ-5D descriptive system by providing a direct, subjective rating of "today's" health status, where 0 represents the worst imaginable health and 100 represents the best imaginable health. It reflects the patient's own perspective, rather than the general population's preferences (which are used for EQ-5D index values).
Functional Scores - EQ-QOL-VAS Value
Time frame: 12 months follow-up
EuroQoL Visual Analog Scale (EQ-VAS ) is a quantitative, self-reported measure of an individual's overall health-related quality of life, ranging from 0 to 100. It complements the EQ-5D descriptive system by providing a direct, subjective rating of "today's" health status, where 0 represents the worst imaginable health and 100 represents the best imaginable health. It reflects the patient's own perspective, rather than the general population's preferences (which are used for EQ-5D index values).
Functional Scores - EQ5D-5L Mobility
Time frame: 2 months follow-up
The EQ-5D-5L mobility dimension measures mobility using five levels: no problems, slight, moderate, severe, and unable to walk, providing high sensitivity. Mobility, often along with pain/discomfort, shows the highest health impairment, ranging from 1 to 5. Level 1 (No problem to walk) Level 2 (Slight problem to walk) Level 3 (Moderate problem to walk) Level 4 (Severe problem to walk) Level 5 (Unable to walk)
Functional Scores - EQ5D-5L Mobility
Time frame: 6 months follow-up
The EQ-5D-5L mobility dimension measures mobility using five levels: no problems, slight, moderate, severe, and unable to walk, providing high sensitivity. Mobility, often along with pain/discomfort, shows the highest health impairment, ranging from 1 to 5. Level 1 (No problem to walk) Level 2 (Slight problem to walk) Level 3 (Moderate problem to walk) Level 4 (Severe problem to walk) Level 5 (Unable to walk)
Functional Scores - EQ5D-5L Mobility
Time frame: 12 months follow-up
The EQ-5D-5L mobility dimension measures mobility using five levels: no problems, slight, moderate, severe, and unable to walk, providing high sensitivity. Mobility, often along with pain/discomfort, shows the highest health impairment, ranging from 1 to 5. Level 1 (No problem to walk) Level 2 (Slight problem to walk) Level 3 (Moderate problem to walk) Level 4 (Severe problem to walk) Level 5 (Unable to walk)
Functional Scores - EQ5D-5L-SELF-CARE
Time frame: 2 months follow-up
The EQ-5D-5L self-care dimension assesses a respondent's ability to wash or dress themselves, ranging from no problems to extreme inability. It features five severity levels to capture subtle changes in functioning, which measures the impact of health conditions on daily, personal care activities. Level 1 (I have no problems with self-care (e.g., washing or dressing)) Level 2 (I have slight problems with self-care) Level 3 (I have moderate problems with self-care) Level 4 (I have severe problems with self-care) Level 5 (I am unable to wash or dress myself (extreme problem))
Functional Scores - EQ5D-5L-SELF-CARE
Time frame: 6 months follow-up
The EQ-5D-5L self-care dimension assesses a respondent's ability to wash or dress themselves, ranging from no problems to extreme inability. It features five severity levels to capture subtle changes in functioning, which measures the impact of health conditions on daily, personal care activities. Level 1 (I have no problems with self-care (e.g., washing or dressing)) Level 2 (I have slight problems with self-care) Level 3 (I have moderate problems with self-care) Level 4 (I have severe problems with self-care) Level 5 (I am unable to wash or dress myself (extreme problem))
Functional Scores - EQ5D-5L-SELF-CARE
Time frame: 12 months follow-up
The EQ-5D-5L self-care dimension assesses a respondent's ability to wash or dress themselves, ranging from no problems to extreme inability. It features five severity levels to capture subtle changes in functioning, which measures the impact of health conditions on daily, personal care activities. Level 1 (I have no problems with self-care (e.g., washing or dressing)) Level 2 (I have slight problems with self-care) Level 3 (I have moderate problems with self-care) Level 4 (I have severe problems with self-care) Level 5 (I am unable to wash or dress myself (extreme problem))
Functional Scores - EQ5D-5L-USUAL-ACTIVITIES
Time frame: 2 months follow-up
The EQ-5D-5L Usual Activities dimension assesses how health problems affect a person's ability to perform daily tasks like work, study, housework, family, or leisure activities. Respondents choose one of five severity levels (no, slight, moderate, severe, or unable) based on their capacity to perform these functions today. Level 1 (No Problems: I have no problems doing my usual activities) Level 2 (Slight Problems: I have slight problems doing my usual activities) Level 3 (Moderate Problems: I have moderate problems doing my usual activities) Level 4 (Severe Problems: I have severe problems doing my usual activities) Level 5 (Unable: I am unable to do my usual activities)
Functional Scores - EQ5D-5L-USUAL-ACTIVITIES
Time frame: 6 months follow-up
The EQ-5D-5L Usual Activities dimension assesses how health problems affect a person's ability to perform daily tasks like work, study, housework, family, or leisure activities. Respondents choose one of five severity levels (no, slight, moderate, severe, or unable) based on their capacity to perform these functions today. Level 1 (No Problems: I have no problems doing my usual activities) Level 2 (Slight Problems: I have slight problems doing my usual activities) Level 3 (Moderate Problems: I have moderate problems doing my usual activities) Level 4 (Severe Problems: I have severe problems doing my usual activities) Level 5 (Unable: I am unable to do my usual activities)
Functional Scores - EQ5D-5L-USUAL-ACTIVITIES
Time frame: 12 months follow-up
The EQ-5D-5L Usual Activities dimension assesses how health problems affect a person's ability to perform daily tasks like work, study, housework, family, or leisure activities. Respondents choose one of five severity levels (no, slight, moderate, severe, or unable) based on their capacity to perform these functions today. Level 1 (No Problems: I have no problems doing my usual activities) Level 2 (Slight Problems: I have slight problems doing my usual activities) Level 3 (Moderate Problems: I have moderate problems doing my usual activities) Level 4 (Severe Problems: I have severe problems doing my usual activities) Level 5 (Unable: I am unable to do my usual activities)
Functional Scores - EQ5D-5L-PAIN/DISCOMFORT
Time frame: 2 months follow-up
The EQ-5D-5L Pain/Discomfort dimension assesses the severity of pain and physical discomfort across five levels, ranging from no problems to extreme problems. It measures how often or intensely a patient experiences pain, itching, or other physical sensations (excluding mental distress), providing a 5-level, more sensitive scale than the 3L version. Level 1 (I have no pain or discomfort) Level 2 (I have slight pain or discomfort) Level 3 (I have moderate pain or discomfort) Level 4 (I have severe pain or discomfort) Level 5 (I have extreme pain or discomfort)
Functional Scores - EQ5D-5L-PAIN/DISCOMFORT
Time frame: 6 months follow-up
The EQ-5D-5L Pain/Discomfort dimension assesses the severity of pain and physical discomfort across five levels, ranging from no problems to extreme problems. It measures how often or intensely a patient experiences pain, itching, or other physical sensations (excluding mental distress), providing a 5-level, more sensitive scale than the 3L version. Level 1 (I have no pain or discomfort) Level 2 (I have slight pain or discomfort) Level 3 (I have moderate pain or discomfort) Level 4 (I have severe pain or discomfort) Level 5 (I have extreme pain or discomfort)
Functional Scores - EQ5D-5L-PAIN/DISCOMFORT
Time frame: 12 months follow-up
The EQ-5D-5L Pain/Discomfort dimension assesses the severity of pain and physical discomfort across five levels, ranging from no problems to extreme problems. It measures how often or intensely a patient experiences pain, itching, or other physical sensations (excluding mental distress), providing a 5-level, more sensitive scale than the 3L version. Level 1 (I have no pain or discomfort) Level 2 (I have slight pain or discomfort) Level 3 (I have moderate pain or discomfort) Level 4 (I have severe pain or discomfort) Level 5 (I have extreme pain or discomfort)
Functional Scores - EQ5D-5L ANXIETY/DEPRESSION
Time frame: 2 months follow-up
The EQ5D-5L Anxiety/Depression dimension assesses the emotional/psychological component of health-related quality of life. It is often used to determine if mental health symptoms amplify reported physical health issues. It measures self-reported levels of anxiety and depression in five severity levels. Level 1 (I am not anxious or depressed) Level 2 (I am slightly anxious or depressed) Level 3 (I am moderately anxious or depressed) Level 4 (I am severely anxious or depressed) Level 5 (I am extremely anxious or depressed)
Functional Scores - EQ5D-5L ANXIETY/DEPRESSION
Time frame: 6 months follow-up
The EQ5D-5L Anxiety/Depression dimension assesses the emotional/psychological component of health-related quality of life. It is often used to determine if mental health symptoms amplify reported physical health issues. It measures self-reported levels of anxiety and depression in five severity levels. Level 1 (I am not anxious or depressed) Level 2 (I am slightly anxious or depressed) Level 3 (I am moderately anxious or depressed) Level 4 (I am severely anxious or depressed) Level 5 (I am extremely anxious or depressed)
Functional Scores - EQ5D-5L ANXIETY/DEPRESSION
Time frame: 12 months follow-up
The EQ5D-5L Anxiety/Depression dimension assesses the emotional/psychological component of health-related quality of life. It is often used to determine if mental health symptoms amplify reported physical health issues. It measures self-reported levels of anxiety and depression in five severity levels. Level 1 (I am not anxious or depressed) Level 2 (I am slightly anxious or depressed) Level 3 (I am moderately anxious or depressed) Level 4 (I am severely anxious or depressed) Level 5 (I am extremely anxious or depressed)
Walking Function - Timed-Up-and-Go (TUG)
Time frame: 2 months follow-up
The Timed-Up-and-Go (TUG) test is a quick, 3-meter walk assessment measuring functional mobility, balance, and fall risk in older adults. Patient starts seated, wearing regular footwear and using their usual walking aid (if needed). Then, the patient rises from a chair, walks 3 meters at a normal pace, turns, walks back, and sits down. Times less than or equivalent to 12 seconds indicate normal, while times greater than or equivalent to 20 seconds signify high fall risk. Scoring and Interpretation < 10 seconds (Normal) < 20 seconds (Independent and generally considered within normal limits for frail elderly) > 20 seconds (Limited functional independence; high fall risk) > 30 seconds (High risk of falling, often requiring assistance)
Walking Function - Timed-Up-and-Go (TUG)
Time frame: 6 months follow-up
The Timed-Up-and-Go (TUG) test is a quick, 3-meter walk assessment measuring functional mobility, balance, and fall risk in older adults. Patient starts seated, wearing regular footwear and using their usual walking aid (if needed). Then, the patient rises from a chair, walks 3 meters at a normal pace, turns, walks back, and sits down. Times less than or equivalent to 12 seconds indicate normal, while times greater than or equivalent to 20 seconds signify high fall risk. Scoring and Interpretation < 10 seconds (Normal) < 20 seconds (Independent and generally considered within normal limits for frail elderly) > 20 seconds (Limited functional independence; high fall risk) > 30 seconds (High risk of falling, often requiring assistance)
Walking Function - Timed-Up-and-Go (TUG)
Time frame: 12 months follow-up
The Timed-Up-and-Go (TUG) test is a quick, 3-meter walk assessment measuring functional mobility, balance, and fall risk in older adults. Patient starts seated, wearing regular footwear and using their usual walking aid (if needed). Then, the patient rises from a chair, walks 3 meters at a normal pace, turns, walks back, and sits down. Times less than or equivalent to 12 seconds indicate normal, while times greater than or equivalent to 20 seconds signify high fall risk. Scoring and Interpretation < 10 seconds (Normal) < 20 seconds (Independent and generally considered within normal limits for frail elderly) > 20 seconds (Limited functional independence; high fall risk) > 30 seconds (High risk of falling, often requiring assistance)
8 secondary outcomes
Survival Rate
Time frame: 6 months
Survival Rate
Time frame: 12 months
Survival Rate
Time frame: 24 months
Number of Subsequent Fracture
Time frame: Within 12 months (1 year)
Second Admission Rate
Time frame: Within 12 months (1 year)
Usage of Walking Aids
Time frame: At 2 months
Usage of Walking Aids
Time frame: At 6 months
Usage of Walking Aids
Time frame: At 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tak Man Wong principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Empowering the patient and caregiver for early and safe discharge of patients with geriatric hip fractures in people with Geriatric Hip Fracture, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional Scores - Modified Barthel Index (MBI) (time frame: 2 months follow-up). The study lists 27 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.