Hip FracturesNCT00155597
The Outcome and Cost Analysis of Home-care Physical Therapy for Postoperative Hip Fracture Patients
A study testing home physical therapy in people with Hip Fractures, run by National Taiwan University Hospital.
Trial summary
The aims of this study are: 1. To develop a disease-specific questionnaire for hip fractures. 2. To find the influences of physical therapy (PT) on patients' function and health-related quality of life (HRQL). 3. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hip Fractures
- What is being tested?
- home physical therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Aug 1999to Jul 2001
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Hip fracture, post surgery
Who cannot join
None listed.
About this study
The aims of this study are:
- To develop a disease-specific questionnaire for hip fractures.
- To find the influences of physical therapy (PT) on patients' function and health-related quality of life (HRQL).
- To estimate the quality adjusted life years (QALY) of cases of hip fracture with or without the PT program by a quality-adjusted survival (QAS) method.
- To perform cost effectiveness analysis (CEA) to evaluate the effectiveness of PT and as a base to compare it with other health intervention programs.
At the beginning of the study, the investigators will develop the disease-specific questionnaire for hip fractures. Cases of patients with hip fractures hospitalized in orthopedic wards of the National Taiwan University Hospital (NTUH) and Chung-Hsing Hospital of Taipei from August 1, 1989 to July 31, 1999 are the study population during the first year of this study. According to their receiving PT or not during hospitalization, the patients are assigned to a PT or non-PT group. The identification (ID) numbers will be matched with the death certificate file of the Department of Health to verify the survival status. Furthermore, 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fractures. Combining the survival function and HRQL, the QALY could be estimated. Cases of hip fracture admitted to the orthopedic ward of NTUH and receiving a PT program from January 1, 2000 will be the second-year study population in this study. They will be randomly assigned to a group of follow-up PT (group I) or non-follow-up PT (group II). The patients assigned to group I will have a 4-time PT evaluation and treatment at home after discharge from the hospital (1 week, 1 month, 3 months and 6 months after discharge). All patients will be evaluated at discharge, 1 month, 6 months, and 1 year after discharge to follow their survival status, functional status and HRQL. The expected results of this study will be to develop the disease-specific questionnaire for hip fractures, to show the functional outcomes of cases of hip fracture, and to estimate the QALY of them.
Read the detailed description
Hip fracture from fall is the most important cause of disability of the aged. Most of the victims receive surgery (internal fixation or arthroplasty) as the primary treatment. However, during the hospitalization of post-surgery, not all the patients receive physical therapy (PT). The program of PT during hospitalization and after discharge affects the functional recovery and the health-related quality of life (HRQL) significantly in our knowledge. Therefore, the aims of this study are:
- To develop the disease-specific questionnaire for hip fracture.
- To find the influences of PT on patients' function and HRQL.
- To estimate the QALY of cases of hip fracture with or without PT program by quality-adjusted survival (QAS) method.
- To perform CEA to evaluate the effectiveness of PT and as a base to compare with other health intervention program.
At the beginning of the study, we will develop the disease-specific questionnaire for hip fracture. And, cases of hip fracture hospitalized in orthopedic wards of National Taiwan University Hospital (NTUH) and Chung-Hsing Hospital of Taipei from August 1, 1989 to July 31, 1999 are the study population of the first year in this study. According to their receiving PT or not during hospitalization, the patients are assigned to PT or non-PT group. Basic data such as ID number, age, sex, comorbidity, pre-injury physical status, operation date, operation type, length of hospitalization, complication, are extracted from their charts. The identification (ID) numbers will be matched with the death certificate file of the Department of Health to make sure the survival status. Furthermore, 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fracture. Combining the survival function and HRQL, the QALY could be estimated. Cases of hip fracture admit to the orthopedic ward of NTUH and receive PT program from Jan. 1, 2000 will be the second-year study population in this study. They will be randomly assigned to group of follow-up PT (group I) or non-follow-up PT (group II). The patients assigned to group I will have 4-time PT evaluation and treatment at home after discharge from hospital (1 week, 1-month, 3-month and 6-month after discharge). All patients will be evaluated at discharge, 1-month, 6-month, and 1-year after discharge to follow their survival status, functional status and HRQL. The patients younger than 65 years old will be further evaluated for their working capacity at the last evaluation. In the third year of this study, medical cost and estimated QALY will be collected to perform the CEA for the effectiveness of PT program during hospitalization and after discharge.
The expected results of this study will be to develop the disease-specific questionnaire for hip fracture, to show the functional outcome of cases with hip fracture, to estimate the QALY of them and to perform a CEA to demonstrate the effectiveness of PT.
- Conditions
- Hip Fractures
- Being tested
- home physical therapy
- Keywords
- physical therapy, post surgery
- Medical subject headings
- Hip Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home physical therapyBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life, Harris score, walking velocity, strength
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 1999
- Primary completionJul 2001
- Study completionJul 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- J Y Tsauo, PhD, Study director, Grad School of PT, College of Medicine, NTU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00155597
- Sponsor's protocol ID
- 24368
- Status last verified
- Dec 2009
- First submitted
- 9 Sep 2005
- Last updated
- 12 Jan 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Outcome and Cost Analysis of Home-care Physical Therapy for Postoperative Hip Fracture Patients
- ClinicalTrials.gov ID
- NCT00155597
- Acronym / sponsor ID
- 24368
- Conditions
- Hip Fractures
- Keywords
- physical therapy, post surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 1999
- Primary completion
- Jul 2001 (actual)
- Study completion
- Jul 2001 (actual)
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aims of this study are:
- To develop a disease-specific questionnaire for hip fractures.
- To find the influences of physical therapy (PT) on patients' function and health-related quality of life (HRQL).
- To estimate the quality adjusted life years (QALY) of cases of hip fracture with or without the PT program by a quality-adjusted survival (QAS) method.
- To perform cost effectiveness analysis (CEA) to evaluate the effectiveness of PT and as a base to compare it with other health intervention programs.
At the beginning of the study, the investigators will develop the disease-specific questionnaire for hip fractures. Cases of patients with hip fractures hospitalized in orthopedic wards of the National Taiwan University Hospital (NTUH) and Chung-Hsing Hospital of Taipei from August 1, 1989 to July 31, 1999 are the study population during the first year of this study. According to their receiving PT or not during hospitalization, the patients are assigned to a PT or non-PT group. The identification (ID) numbers will be matched with the death certificate file of the Department of Health to verify the survival status. Furthermore, 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fractures. Combining the survival function and HRQL, the QALY could be estimated. Cases of hip fracture admitted to the orthopedic ward of NTUH and receiving a PT program from January 1, 2000 will be the second-year study population in this study. They will be randomly assigned to a group of follow-up PT (group I) or non-follow-up PT (group II). The patients assigned to group I will have a 4-time PT evaluation and treatment at home after discharge from the hospital (1 week, 1 month, 3 months and 6 months after discharge). All patients will be evaluated at discharge, 1 month, 6 months, and 1 year after discharge to follow their survival status, functional status and HRQL. The expected results of this study will be to develop the disease-specific questionnaire for hip fractures, to show the functional outcomes of cases of hip fracture, and to estimate the QALY of them.
Detailed description
Hip fracture from fall is the most important cause of disability of the aged. Most of the victims receive surgery (internal fixation or arthroplasty) as the primary treatment. However, during the hospitalization of post-surgery, not all the patients receive physical therapy (PT). The program of PT during hospitalization and after discharge affects the functional recovery and the health-related quality of life (HRQL) significantly in our knowledge. Therefore, the aims of this study are:
- To develop the disease-specific questionnaire for hip fracture.
- To find the influences of PT on patients' function and HRQL.
- To estimate the QALY of cases of hip fracture with or without PT program by quality-adjusted survival (QAS) method.
- To perform CEA to evaluate the effectiveness of PT and as a base to compare with other health intervention program.
At the beginning of the study, we will develop the disease-specific questionnaire for hip fracture. And, cases of hip fracture hospitalized in orthopedic wards of National Taiwan University Hospital (NTUH) and Chung-Hsing Hospital of Taipei from August 1, 1989 to July 31, 1999 are the study population of the first year in this study. According to their receiving PT or not during hospitalization, the patients are assigned to PT or non-PT group. Basic data such as ID number, age, sex, comorbidity, pre-injury physical status, operation date, operation type, length of hospitalization, complication, are extracted from their charts. The identification (ID) numbers will be matched with the death certificate file of the Department of Health to make sure the survival status. Furthermore, 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fracture. Combining the survival function and HRQL, the QALY could be estimated. Cases of hip fracture admit to the orthopedic ward of NTUH and receive PT program from Jan. 1, 2000 will be the second-year study population in this study. They will be randomly assigned to group of follow-up PT (group I) or non-follow-up PT (group II). The patients assigned to group I will have 4-time PT evaluation and treatment at home after discharge from hospital (1 week, 1-month, 3-month and 6-month after discharge). All patients will be evaluated at discharge, 1-month, 6-month, and 1-year after discharge to follow their survival status, functional status and HRQL. The patients younger than 65 years old will be further evaluated for their working capacity at the last evaluation. In the third year of this study, medical cost and estimated QALY will be collected to perform the CEA for the effectiveness of PT program during hospitalization and after discharge.
The expected results of this study will be to develop the disease-specific questionnaire for hip fracture, to show the functional outcome of cases with hip fracture, to estimate the QALY of them and to perform a CEA to demonstrate the effectiveness of PT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Hip fracture, post surgery
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| home physical therapy | Behavioural | – |
Primary outcome
Quality of Life, Harris score, walking velocity, strength
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2010.
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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.
J Y Tsauo, PhD study director
Grad School of PT, College of Medicine, NTU
Questions about this trial
What is this clinical trial studying?
A study testing home physical therapy in people with Hip Fractures, run by National Taiwan University Hospital.
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 1 inclusion and 0 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 12 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Quality of Life, Harris score, walking velocity, strength. 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 12 Jan 2010.