StrokeNCT07776392
Occupational Therapy Instructmental Activities of Daily Living and Psychosocial Modules Program for Stroke Survivors
A study testing One group received the psychosocial intervention, while the other group engaged in IADL interventions. in people with Stroke, run by Texas Woman's University at 1 site in United States.
Trial summary
The study aims to recruit and enroll 25 participants who meet specific criteria, which will be communicated to potential participants, along with information about the study\'s goals, time commitments, benefits, and risks. Participants can ask questions and receive consent forms to review and sign. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Stroke
- What is being tested?
- One group received the psychosocial intervention, while the other group engaged in IADL interventions.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2024to 17 May 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be at least 18 years old;
- Have a history of unilateral stroke no less than 3 months and be medically stable prior to the study
- Be able to follow three-step commands
- Have a score equal to or less than 20 on the 9-question Patient Health Questionnaire for without depression
- Participants must commit to 8 weeks to participate in the full OT lifestyle redesign program
- Be able to speak and understand English, as the program and study materials are in English
- Internet access for zoom is required for participants
Who cannot join
- Acute medical problems
- Presence of any contraindications, injuries, or surgeries
- Significant pain that interferes with participation in program activities
- Use of medications that may affect participant's level of consciousness or fatigue
- Impaired cognition level: Participants will need to have normal cognition in order to understand the study procedure. Therefore, we will use the Mini-Mental State Exam (MMSE) survey, with a total score of 30, to screen cognition. If the score on the MMSE survey is less than 24, the participant will be excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Occupational Therapy Instrumental Activities of Daily Living and Psychosocial Program for Healthy Habits and Role of Stroke Survivors
The study aims to recruit and enroll 25 participants who meet specific criteria, which will be communicated to potential participants, along with information about the study\'s goals, time commitments, benefits, and risks. Participants can ask questions and receive consent forms to review and sign. Once participants sign consent forms, the primary investigator will generate non-identifiable codes for each participant using an Excel spreadsheet to maintain confidentiality and protect participant identities. Participants will be randomly assigned to one of two groups to minimize potential bias and ensure that each group is representative of the overall population. One group will receive a psychosocial intervention, while the other group will engage in instrumental activities of daily living.
Read the detailed description
Stroke is a prevalent disability that affects 1 in 4 people in their lifetime, according to the World Stroke Organization. Stroke survivors often experience decreased active participation, long-term disabilities, and increased healthcare-related costs, highlighting the critical need for a local client-centered program that prioritizes the well-being and independence of stroke survivors. In a scoping review, Pyatak et al. found that community-based occupational therapy programs improve diverse older adults' quality of life, physical functioning, and mental health. These programs use personal goal setting, meaningful activities, and peer support to enhance overall well-being. They also address health disparities and emphasize client-centered approaches in culturally diverse communities. Lifestyle Redesign, a key component, teaches individuals how their daily choices impact long-term functioning, health, and well-being. This study aims to enhance the overall life satisfaction of stroke survivors by implementing an 8-week program that utilizes a comprehensive and personalized approach with client-based interventions. The program will incorporate various interventions such as meal preparation, exercise and leisure activities, health literacy, caregiver training, and mental well-being.
Research conducted by Guillaumier et al. has shown that online access is a promising approach to increasing effectiveness and improving outcomes. In light of this, weekly interventions for this study will be conducted online to address participants' questions, implement a home exercise program, and increase the accessibility of the program to stroke survivors who may have difficulty attending in-person appointments. This study proposal also aims to bridge the healthcare system and provide the support required for stroke survivors to navigate a healthy lifestyle. Additionally, the program seeks to enhance the life satisfaction of stroke survivors by addressing their physical, mental, and social health and well-being. By providing a holistic approach to stroke recovery, the program is designed to improve the quality of life for stroke survivors, alleviate the strain on healthcare resources, and provide the necessary support required for stroke survivors to maintain a healthy lifestyle.
- Conditions
- Stroke
- Being tested
- One group received the psychosocial intervention, while the other group engaged in IADL interventions.
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One group received the psychosocial intervention, while the other group engaged in IADL interventions.Behavioural
The program took place in two separate office rooms at a Stroke Center at North Texas University. Participants engaged in an eight-week program targeting strategies for IADLs. Group sessions were held in person and lasted approximately 45 minutes. The sessions included an opening message, instructions, and structured group discussions. Research conducted by Guillaumier et al. (2022) has demonstrated that online access is a promising approach to increasing program effectiveness and improving outcomes. In light of this, this study will leverage a weekly, less than 30-minute phone consultation to address participants\' questions, implement a home exercise program, and enhance accessibility for stroke survivors who may face challenges attending in-person appointments. Additionally, individual sessions were conducted via phone to cover the material discussed for that week and to facilitate knowledge retention, reflection, and teach-back opportunities by the research team members.
| Study group | Role | What they receive |
|---|---|---|
| Stroke survivors were recruited from The Stroke Center in Texas. | Experimental | Participants engaged in an eight-week program targeting strategies for IADLs. Group sessions were held in person and lasted approximately 45 minutes. Receives: Behavioral: One group received the psychosocial intervention, while the other group engaged in IADL interventions. |
| Psychosocial modules | Active comparator | psychosocial modules, including healthy habits, routines, and mental well-being Receives: Behavioral: One group received the psychosocial intervention, while the other group engaged in IADL interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Canadian Occupational Performance Measure
Participants repeated the Canadian Occupational Performance Measure (COPM) to assess satisfaction and performance and pre- and post-surveys to evaluate their knowledge of healthy habits and roles in terms of creating new roles, active participation, life habit enhancement, and preventative care.
This outcome measure is a scale (1-10), where 1 = not important at all and 10 = very important in terms of satisfaction and performance.
Measured: The pre- and post-surveys evaluate their change from the baseline prior to treatment, and the post-surveys are within one week of 8 weeks of intervention sessions.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start8 Jan 2024
- Primary completion17 May 2024
- Study completion17 May 2024
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas Woman's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, William Sit, Texas Woman's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07776392
- Sponsor's protocol ID
- IRB-FY2024-14
- Status last verified
- Aug 2026
- First submitted
- 13 Aug 2026
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Occupational Therapy Instrumental Activities of Daily Living and Psychosocial Program for Healthy Habits and Role of Stroke Survivors
- ClinicalTrials.gov ID
- NCT07776392
- Acronym / sponsor ID
- IRB-FY2024-14
- Conditions
- Stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Texas Woman's UniversityUniversity, hospital or other
- Study start
- 8 Jan 2024 (actual)
- Primary completion
- 17 May 2024 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 20 Aug 2026 (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.
The study aims to recruit and enroll 25 participants who meet specific criteria, which will be communicated to potential participants, along with information about the study\'s goals, time commitments, benefits, and risks. Participants can ask questions and receive consent forms to review and sign. Once participants sign consent forms, the primary investigator will generate non-identifiable codes for each participant using an Excel spreadsheet to maintain confidentiality and protect participant identities. Participants will be randomly assigned to one of two groups to minimize potential bias and ensure that each group is representative of the overall population. One group will receive a psychosocial intervention, while the other group will engage in instrumental activities of daily living.
Detailed description
Stroke is a prevalent disability that affects 1 in 4 people in their lifetime, according to the World Stroke Organization. Stroke survivors often experience decreased active participation, long-term disabilities, and increased healthcare-related costs, highlighting the critical need for a local client-centered program that prioritizes the well-being and independence of stroke survivors. In a scoping review, Pyatak et al. found that community-based occupational therapy programs improve diverse older adults' quality of life, physical functioning, and mental health. These programs use personal goal setting, meaningful activities, and peer support to enhance overall well-being. They also address health disparities and emphasize client-centered approaches in culturally diverse communities. Lifestyle Redesign, a key component, teaches individuals how their daily choices impact long-term functioning, health, and well-being. This study aims to enhance the overall life satisfaction of stroke survivors by implementing an 8-week program that utilizes a comprehensive and personalized approach with client-based interventions. The program will incorporate various interventions such as meal preparation, exercise and leisure activities, health literacy, caregiver training, and mental well-being.
Research conducted by Guillaumier et al. has shown that online access is a promising approach to increasing effectiveness and improving outcomes. In light of this, weekly interventions for this study will be conducted online to address participants' questions, implement a home exercise program, and increase the accessibility of the program to stroke survivors who may have difficulty attending in-person appointments. This study proposal also aims to bridge the healthcare system and provide the support required for stroke survivors to navigate a healthy lifestyle. Additionally, the program seeks to enhance the life satisfaction of stroke survivors by addressing their physical, mental, and social health and well-being. By providing a holistic approach to stroke recovery, the program is designed to improve the quality of life for stroke survivors, alleviate the strain on healthcare resources, and provide the necessary support required for stroke survivors to maintain a healthy lifestyle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stroke survivors were recruited from The Stroke Center in Texas. | Experimental | Behavioral: One group received the psychosocial intervention, while the other group engaged in IADL interventions.Participants engaged in an eight-week program targeting strategies for IADLs. Group sessions were held in person and lasted approximately 45 minutes. |
| Psychosocial modules | Active comparator | Behavioral: One group received the psychosocial intervention, while the other group engaged in IADL interventions.psychosocial modules, including healthy habits, routines, and mental well-being |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Be at least 18 years old;
- Have a history of unilateral stroke no less than 3 months and be medically stable prior to the study
- Be able to follow three-step commands
- Have a score equal to or less than 20 on the 9-question Patient Health Questionnaire for without depression
- Participants must commit to 8 weeks to participate in the full OT lifestyle redesign program
Key exclusion criteria (5 listed)
- Acute medical problems
- Presence of any contraindications, injuries, or surgeries
- Significant pain that interferes with participation in program activities
- Use of medications that may affect participant's level of consciousness or fatigue
- Impaired cognition level: Participants will need to have normal cognition in order to understand the study procedure. Therefore, we will use the Mini-Mental State Exam (MMSE) survey, with a total score of 30, to screen cognition. If the score on the MMSE survey is less than 24, the participant will be excluded.
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 |
|---|---|---|
| One group received the psychosocial intervention, while the other group engaged in IADL interventions.The program took place in two separate office rooms at a Stroke Center at North Texas University. Participants engaged in an eight-week program targeting strategies for IADLs. Group sessions were held in person and lasted approximately 45 minutes. The sessions included an opening message, instructions, and structured group discussions. Research conducted by Guillaumier et al. (2022) has demonstrated that online access is a promising approach to increasing program effectiveness and improving outcomes. In light of this, this study will leverage a weekly, less than 30-minute phone consultation to address participants\' questions, implement a home exercise program, and enhance accessibility for stroke survivors who may face challenges attending in-person appointments. Additionally, individual sessions were conducted via phone to cover the material discussed for that week and to facilitate knowledge retention, reflection, and teach-back opportunities by the research team members. | Behavioural | Psychosocial modules, Stroke survivors were recruited from The Stroke Center in Texas. |
Primary outcome
Canadian Occupational Performance Measure
Time frame: The pre- and post-surveys evaluate their change from the baseline prior to treatment, and the post-surveys are within one week of 8 weeks of intervention sessions.
Participants repeated the Canadian Occupational Performance Measure (COPM) to assess satisfaction and performance and pre- and post-surveys to evaluate their knowledge of healthy habits and roles in terms of creating new roles, active participation, life habit enhancement, and preventative care. This outcome measure is a scale (1-10), where 1 = not important at all and 10 = very important in terms of satisfaction and performance.
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 20 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing One group received the psychosocial intervention, while the other group engaged in IADL interventions. in people with Stroke, run by Texas Woman's University at 1 site in United States.
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 7 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 20 Aug 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 United States. 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?
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?
Canadian Occupational Performance Measure (time frame: The pre- and post-surveys evaluate their change from the baseline prior to treatment, and the post-surveys are within one week of 8 weeks of intervention sessions.). 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 20 Aug 2026.