StrokeNCT06280599
Transitional Care Model for Patients With Stroke
A study testing Transitional care model in people with Stroke, run by Kaohsiung Medical University at 1 site in Indonesia.
Trial summary
Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Stroke
- What is being tested?
- Transitional care model
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Sep 2023to 29 Apr 2024
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being at least 18 years old, being admitted in neurology department for at least 24 to 48 hours,
- Not having cognitive impairment as measured by the Montreal cognitive assessment (score ≥ 23),
- Being able to communicate in Indonesia, having the ability to provide informed consent,
- Being willing to participate in this study during hospitalization and 8 weeks after hospital discharge
Who cannot join
- Have potentially biased information, such as being unable to provide informed consent due to cognitive impairment,
- Having major speech and language problems or aphasia that prevent them from participating in the study,
- Having serious psychiatric disorders or other with terminal disease requiring active treatment, and
- Being discharged to a nursing home or welfare institution.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site, 1 recruiting
- Recruiting
RSUD Prof. Dr. W Z Johannes Kupang
Kupang, 308
Sakti Oktaria Batubara, oktariabatubara@gmail.com
itadaryanti05@gmail.com
About this study
Official title: An Experimental Study of the Application of Transitional Care Model on Patients With Stroke
Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings.
Read the detailed description
A stroke may be a profound and life-changing occurrence for both the survivors and those who care for them, mandating participation in the adaptation and reinvention of a new post-stroke lifestyle that is sometimes unpredictable and temperamental. The sudden onset of a stroke and its accompanying treatment in an acute hospital setting can be distressing for both patients and caregivers. Admission after stroke may have a profound impact as patients and their caregiver start to understand the effects of the occurrence, which is scary, puzzling, and stressful. Nonetheless, adjusting to situations or life after a stroke might be made easier by implementing relevant and timely strategies throughout hospitalization, discharge, and the post-discharge period. Both populations, stroke patients and caregivers, may have unmet needs once the patients are discharged at home, such as communication, recovery plan and process, medicine, emotional needs, and stroke information, as well as social involvement. To address unmet needs after discharge from the hospital to a variety of settings, such transitional care is recommended to tackle the adverse outcomes.One of the widely used transitional care models is TCM, which was developed at the University of Pennsylvania under the direction of a nurse and was then made available to patients who were elderly at risk of poor outcomes and suffering from chronic illnesses including stroke patients. Incorporated into the model, TCM were developed to meet the needs that arose during hospitalization and to provide continuity of care for patients, including those with stroke, who were unable to receive it after their acute illness treatment
- Conditions
- Stroke
- Being tested
- Transitional care model
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transitional care modelBehavioural
In-hospital assessments, video-based stroke education, home visits, and weekly telephone follow-up
| Study group | Role | What they receive |
|---|---|---|
| Transitional care model | Experimental | In-hospital assessments, video-based stroke education, home visits, and weekly telephone follow-up Receives: Behavioral: Transitional care model |
| Post-stroke usual care | No intervention | Treatment as usual after discharged home |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-efficacy
Self-efficacy has been proposed as an important determinant of the adaptation process in people who have had a stroke. The Indonesian version of Stroke Self-Efficacy Questionnaire (SSEQ-I) will be used in this study to assess participants' beliefs in their ability to perform and manage daily activities following a stroke. Participants rate their confidence in their ability to complete each of the 13 items on a 10-point scale, with 0 representing not at all confident and 10 representing very confident. Higher score indicates a higher level of self-efficacy (range 0-130).
Measured: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Activities of daily living
The ability to perform ADLs independently is a short-term rehabilitation goal during stroke recovery. The Indonesian version of the Modified Barthel Index (MBI-I) will be used to assess behavior related to activities of daily living in stroke patients or patients with other disabling conditions. The ten functional domains (activities) covered by this questionnaire include bowel and bladder control, grooming assistance, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing. Each item is graded on a scale of 0 to a maximum of 15. A total item score of less than or equal to 20 indicates total dependence, 21-60 severe dependence, 61-90 moderate dependence, 91-99 slight dependence and a total 100 indicates independence.
Measured: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Secondary outcomes (3)
Instrumental activities of daily living
The Lawton IADL-Indonesian Version will be used to assess engagement in more complex activities in stroke patients. Each item is graded on a 2-point scale. The total score can range between 0 and 8. A total score is obtained by adding the items and normalizing to 8 for high function or independence for woman and 5 for man. For women, a score of 0 indicates total dependence or low function, 1-7 dependence or mild to moderate function, and a total 8 indicates independence or high function. For men, a score of 0 indicates total dependence or low function, 1-4 dependence or mild to moderate function, and a total 5 indicates independence or high function.
Measured: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Depression symptoms
Depression symptoms following a stroke covers roughly one-third of stroke survivors at any given time after the stroke. The Indonesian version of Geriatric Depression Scale (GDS), will be used to assess depression in stroke patients. Each item with 15 questions was scored on a 2-point scale (0 = "no," 1 = "yes"). Scores between 0 and 4 are considered normal, scores between 5-8, 9 to 11, and 12 to 15 indicate mild, moderate, and severe depression (range 0-15).
Measured: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Quality of life in stroke patients
The 26-item Indonesian version of World Health Organization Quality of Life-BREF (WHOQoL-BREF) will be used to assess the quality of life of stroke patients. This questionnaire comprises on four dimensions including physical health, psychological health, social relationships, and environmental health. Each dimension had five Likert response options, which were recoded into scores ranging from 0 to 4, with 0 being "never" and 4 being "always". Higher score indicates more severe of frequent problems or lower level of quality of life (range 0-104).
Measured: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Sep 2023
- Primary completion1 Apr 2024 (estimated)
- Study completion29 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The patients were divided into two groups: intervention (n=40) and contrast (n=40). Both groups received post-stroke usual care. The intervention group received an 8-week transitional care model for stroke patients, which included comprehensive discharge planning and home follow-up
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ita Daryanti Saragih, Kaohsiung Medical University
- Investigators
- Bih-O Lee, Professor, Study chair, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06280599
- Sponsor's protocol ID
- SON KMU
- Status last verified
- Apr 2024
- First submitted
- 20 Feb 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Experimental Study of the Application of Transitional Care Model on Patients With Stroke
- ClinicalTrials.gov ID
- NCT06280599
- Acronym / sponsor ID
- SON KMU
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Kaohsiung Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 29 Apr 2024 (estimated)
- First posted
- 28 Feb 2024 (actual)
- 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.
Patients with stroke benefitted from superior improvements in physical function, particularly when performing activities of daily living, fewer visits to the emergency room, less depression symptoms, and improved health-related quality of life thanks to transitional model care. Despite widespread implementation of transitional care for stroke patients, intervention effectiveness remains inconclusive, and another concern with transitional care for patients is the scarcity of effects on specific findings.
Detailed description
A stroke may be a profound and life-changing occurrence for both the survivors and those who care for them, mandating participation in the adaptation and reinvention of a new post-stroke lifestyle that is sometimes unpredictable and temperamental. The sudden onset of a stroke and its accompanying treatment in an acute hospital setting can be distressing for both patients and caregivers. Admission after stroke may have a profound impact as patients and their caregiver start to understand the effects of the occurrence, which is scary, puzzling, and stressful. Nonetheless, adjusting to situations or life after a stroke might be made easier by implementing relevant and timely strategies throughout hospitalization, discharge, and the post-discharge period. Both populations, stroke patients and caregivers, may have unmet needs once the patients are discharged at home, such as communication, recovery plan and process, medicine, emotional needs, and stroke information, as well as social involvement. To address unmet needs after discharge from the hospital to a variety of settings, such transitional care is recommended to tackle the adverse outcomes.One of the widely used transitional care models is TCM, which was developed at the University of Pennsylvania under the direction of a nurse and was then made available to patients who were elderly at risk of poor outcomes and suffering from chronic illnesses including stroke patients. Incorporated into the model, TCM were developed to meet the needs that arose during hospitalization and to provide continuity of care for patients, including those with stroke, who were unable to receive it after their acute illness treatment
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The patients were divided into two groups: intervention (n=40) and contrast (n=40). Both groups received post-stroke usual care. The intervention group received an 8-week transitional care model for stroke patients, which included comprehensive discharge planning and home follow-up
| Arm | Type | Receives |
|---|---|---|
| Transitional care model | Experimental | Behavioral: Transitional care modelIn-hospital assessments, video-based stroke education, home visits, and weekly telephone follow-up |
| Post-stroke usual care | No intervention | –Treatment as usual after discharged home |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Being at least 18 years old, being admitted in neurology department for at least 24 to 48 hours,
- Not having cognitive impairment as measured by the Montreal cognitive assessment (score ≥ 23),
- Being able to communicate in Indonesia, having the ability to provide informed consent,
- Being willing to participate in this study during hospitalization and 8 weeks after hospital discharge
Key exclusion criteria (4 listed)
- Have potentially biased information, such as being unable to provide informed consent due to cognitive impairment,
- Having major speech and language problems or aphasia that prevent them from participating in the study,
- Having serious psychiatric disorders or other with terminal disease requiring active treatment, and
- Being discharged to a nursing home or welfare institution.
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 |
|---|---|---|
| Transitional care modelIn-hospital assessments, video-based stroke education, home visits, and weekly telephone follow-up | Behavioural | Transitional care model |
Primary outcome
Self-efficacy
Time frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Self-efficacy has been proposed as an important determinant of the adaptation process in people who have had a stroke. The Indonesian version of Stroke Self-Efficacy Questionnaire (SSEQ-I) will be used in this study to assess participants' beliefs in their ability to perform and manage daily activities following a stroke. Participants rate their confidence in their ability to complete each of the 13 items on a 10-point scale, with 0 representing not at all confident and 10 representing very confident. Higher score indicates a higher level of self-efficacy (range 0-130).
Activities of daily living
Time frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8
The ability to perform ADLs independently is a short-term rehabilitation goal during stroke recovery. The Indonesian version of the Modified Barthel Index (MBI-I) will be used to assess behavior related to activities of daily living in stroke patients or patients with other disabling conditions. The ten functional domains (activities) covered by this questionnaire include bowel and bladder control, grooming assistance, toilet use, feeding, transfers, walking, dressing, climbing stairs, and bathing. Each item is graded on a scale of 0 to a maximum of 15. A total item score of less than or equal to 20 indicates total dependence, 21-60 severe dependence, 61-90 moderate dependence, 91-99 slight dependence and a total 100 indicates independence.
3 secondary outcomes
Instrumental activities of daily living
Time frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Depression symptoms
Time frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Quality of life in stroke patients
Time frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
- Individual participant dataSharing planned: No
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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.
Bih-O Lee, Professor study chair
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transitional care model in people with Stroke, run by Kaohsiung Medical University at 1 site in Indonesia.
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 4 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: status not confirmed, as of the sponsor's last update on 3 Apr 2024. 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 Indonesia. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ita Saragih, PhD student (+886 986 226143, itadaryanti05@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-efficacy (time frame: Baseline, at week 4 intervention, and immediately post-intervention at week 8). The study lists 2 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 3 Apr 2024.