StrokeNCT07725666
Co-Designed Digital Education and Peer Support for Young and Middle-Aged Stroke Survivors
A study testing Patient-Centered Digital Education and Peer Support Program and Usual Post-Stroke Care in people with Stroke and Stroke (6 Months or More After Onset), run by Chang Gung Memorial Hospital.
Trial summary
Stroke survivors often experience persistent unmet needs during long-term recovery. Young and middle-aged stroke survivors may face additional challenges in balancing rehabilitation with work and family responsibilities. Read more about this study
- Who is it for?
- Ages 31 to 64 years
- Conditions the study is for
- Stroke, Stroke (6 Months or More After Onset)
- What is being tested?
- Patient-Centered Digital Education and Peer Support Program and Usual Post-Stroke Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 31 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged 31 to 64 years.
- Diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) and physician diagnosis.
- Received treatment at the Stroke Center of Linkou Chang Gung Memorial Hospital.
- Conscious and able to communicate, including individuals with mild aphasia.
- Willing and able to provide informed consent.
Who cannot join
- End-stage cancer.
- Severe aphasia resulting in inability to communicate.
- Dependent in basic activities of daily living before the index stroke (Barthel Index <100), regardless of the underlying cause.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Co-Designed Digital Education and Peer Support Intervention for Reducing Unmet Needs and Enhancing Recovery Among Young and Middle-Aged Stroke Survivors
Stroke survivors often experience persistent unmet needs during long-term recovery. Young and middle-aged stroke survivors may face additional challenges in balancing rehabilitation with work and family responsibilities. Although digital health interventions have the potential to improve access to education and self-management support, existing programs are often provider-driven, provide limited peer support, and have short follow-up periods.
This study aims to evaluate the effectiveness of a patient-centered digital education and peer support intervention co-designed with young and middle-aged stroke survivors. Participants will be randomly assigned to either the intervention group or the usual care group. The intervention will be delivered through LINE communities and Google collaborative platforms over a 12-month period. The primary outcome is unmet needs. Secondary outcomes include stroke self-efficacy, depressive symptoms, quality of life, activities of daily living, instrumental activities of daily living, and return-to-work status.
Read the detailed description
Stroke survivors require continuous support to develop healthy lifestyles and self-management behaviors after hospital discharge. However, young and middle-aged stroke survivors often have work and family responsibilities that limit participation in conventional face-to-face education programs. Digital health interventions may improve accessibility and flexibility; however, previous studies have primarily been healthcare provider-led, with limited patient involvement in intervention development, insufficient peer support, relatively short intervention periods, and limited assessment of psychosocial outcomes.
This study consists of two phases. During Phase I, young and middle-aged stroke survivors will participate in a co-design process to develop a patient-centered digital education and peer support intervention. Feedback from a pilot study will be used to refine the intervention before the randomized controlled trial.
During Phase II, eligible participants will be randomly assigned to either the intervention group or the usual care group. Participants in the intervention group will receive a 12-month digital education and peer support program delivered through LINE communities and Google collaborative platforms. The program includes digital educational materials, peer interaction, online meetings, and ongoing support from healthcare professionals. Participants in the control group will receive usual post-stroke care.
Outcome measures will be collected at baseline and at 1, 3, 6, and 12 months after enrollment. The primary outcome is unmet needs. Secondary outcomes include stroke self-efficacy, depressive symptoms, quality of life, activities of daily living, instrumental activities of daily living, and return-to-work status. Longitudinal changes between groups will be analyzed using generalized estimating equations (GEE).
- Conditions
- Stroke, Stroke (6 Months or More After Onset)
- Being tested
- Patient-Centered Digital Education and Peer Support Program, Usual Post-Stroke Care
- Keywords
- Stroke, Digital Health, Peer Support
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient-Centered Digital Education and Peer Support ProgramBehavioural
A 12-month patient-centered digital education and peer support program delivered through LINE communities and Google collaborative platforms.
Usual Post-Stroke CareOther
Routine post-stroke care provided by the participating hospital, including standard discharge education and follow-up telephone contacts.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Participants will receive a 12-month patient-centered digital education and peer support program Receives: Behavioral: Patient-Centered Digital Education and Peer Support Program |
| Usual Care | Active comparator | Participants will receive usual post-stroke care, including routine follow-up and telephone contacts, without access to the digital education and peer support program. Receives: Other: Usual Post-Stroke Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Unmet Needs
Assessed using the Unmet Needs Questionnaire for young stroke survivors
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Secondary outcomes (6)
Self-Efficacy
Assessed using the Chinese version of the Stroke Self-Efficacy Questionnaire
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Depressive Symptoms
Assessed using the Taiwanese Depression Questionnaire
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
WHOQOL-BREF Score
Assessed using the Taiwan version of the WHOQOL-BREF.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Activities of Daily Living
Assessed using the Barthel Index.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Instrumental Activities of Daily Living
Assessed using the Lawton Instrumental Activities of Daily Living Scale.
Measured: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Return-to-Work Status
Assessed using a structured return-to-work questionnaire developed for this study.
Measured: 1 month, 3 months, 6 months, and 12 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study startNov 2026 (estimated)
- Primary completionJul 2028 (estimated)
- Study completionJul 2029 (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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 148 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen-Yu Kuo, PhD, Principal investigator, Chang Gung University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07725666
- Sponsor's protocol ID
- 202501542A3
- Other IDs
- NSTC 115-2314-B-255-010-MY3
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2026
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Co-Designed Digital Education and Peer Support Intervention for Reducing Unmet Needs and Enhancing Recovery Among Young and Middle-Aged Stroke Survivors
- ClinicalTrials.gov ID
- NCT07725666
- Acronym / sponsor ID
- 202501542A3
- Conditions
- Stroke, Stroke (6 Months or More After Onset)
- Keywords
- Stroke, Digital Health, Peer Support
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 148 participants (estimated)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 24 Jul 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.
Stroke survivors often experience persistent unmet needs during long-term recovery. Young and middle-aged stroke survivors may face additional challenges in balancing rehabilitation with work and family responsibilities. Although digital health interventions have the potential to improve access to education and self-management support, existing programs are often provider-driven, provide limited peer support, and have short follow-up periods.
This study aims to evaluate the effectiveness of a patient-centered digital education and peer support intervention co-designed with young and middle-aged stroke survivors. Participants will be randomly assigned to either the intervention group or the usual care group. The intervention will be delivered through LINE communities and Google collaborative platforms over a 12-month period. The primary outcome is unmet needs. Secondary outcomes include stroke self-efficacy, depressive symptoms, quality of life, activities of daily living, instrumental activities of daily living, and return-to-work status.
Detailed description
Stroke survivors require continuous support to develop healthy lifestyles and self-management behaviors after hospital discharge. However, young and middle-aged stroke survivors often have work and family responsibilities that limit participation in conventional face-to-face education programs. Digital health interventions may improve accessibility and flexibility; however, previous studies have primarily been healthcare provider-led, with limited patient involvement in intervention development, insufficient peer support, relatively short intervention periods, and limited assessment of psychosocial outcomes.
This study consists of two phases. During Phase I, young and middle-aged stroke survivors will participate in a co-design process to develop a patient-centered digital education and peer support intervention. Feedback from a pilot study will be used to refine the intervention before the randomized controlled trial.
During Phase II, eligible participants will be randomly assigned to either the intervention group or the usual care group. Participants in the intervention group will receive a 12-month digital education and peer support program delivered through LINE communities and Google collaborative platforms. The program includes digital educational materials, peer interaction, online meetings, and ongoing support from healthcare professionals. Participants in the control group will receive usual post-stroke care.
Outcome measures will be collected at baseline and at 1, 3, 6, and 12 months after enrollment. The primary outcome is unmet needs. Secondary outcomes include stroke self-efficacy, depressive symptoms, quality of life, activities of daily living, instrumental activities of daily living, and return-to-work status. Longitudinal changes between groups will be analyzed using generalized estimating equations (GEE).
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Behavioral: Patient-Centered Digital Education and Peer Support ProgramParticipants will receive a 12-month patient-centered digital education and peer support program |
| Usual Care | Active comparator | Other: Usual Post-Stroke CareParticipants will receive usual post-stroke care, including routine follow-up and telephone contacts, without access to the digital education and peer support program. |
Who may qualify
- Ages
- 31 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Aged 31 to 64 years.
- Diagnosis of stroke confirmed by computed tomography (CT) or magnetic resonance imaging (MRI) and physician diagnosis.
- Received treatment at the Stroke Center of Linkou Chang Gung Memorial Hospital.
- Conscious and able to communicate, including individuals with mild aphasia.
- Willing and able to provide informed consent.
Key exclusion criteria (3 listed)
- End-stage cancer.
- Severe aphasia resulting in inability to communicate.
- Dependent in basic activities of daily living before the index stroke (Barthel Index <100), regardless of the underlying cause.
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 |
|---|---|---|
| Patient-Centered Digital Education and Peer Support ProgramA 12-month patient-centered digital education and peer support program delivered through LINE communities and Google collaborative platforms. | Behavioural | Experimental |
| Usual Post-Stroke CareRoutine post-stroke care provided by the participating hospital, including standard discharge education and follow-up telephone contacts. | Other | Usual Care |
Primary outcome
Unmet Needs
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using the Unmet Needs Questionnaire for young stroke survivors
6 secondary outcomes
Self-Efficacy
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Depressive Symptoms
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
WHOQOL-BREF Score
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Activities of Daily Living
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Instrumental Activities of Daily Living
Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Return-to-Work Status
Time frame: 1 month, 3 months, 6 months, and 12 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2026.
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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.
Wen-Yu Kuo, PhD principal investigator
Chang Gung University of Science and Technology
Questions about this trial
What is this clinical trial studying?
A study testing Patient-Centered Digital Education and Peer Support Program and Usual Post-Stroke Care in people with Stroke and Stroke (6 Months or More After Onset), run by Chang Gung Memorial 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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 22 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen-YU Kuo, PhD (+886-3-2118999 ext. 3411, wykuo@mail.cgust.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Unmet Needs (time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment). 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 22 Oct 2026.