- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07725666
Co-Designed Digital Education and Peer Support for Young and Middle-Aged Stroke Survivors
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.
연구 개요
상태
상세 설명
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).
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Wen-YU Kuo, PhD
- 전화번호: 3411 +886-3-2118999
- 이메일: wykuo@mail.cgust.edu.tw
참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Experimental
Participants will receive a 12-month patient-centered digital education and peer support program
|
A 12-month patient-centered digital education and peer support program delivered through LINE communities and Google collaborative platforms.
|
|
활성 비교기: Usual Care
Participants will receive usual post-stroke care, including routine follow-up and telephone contacts, without access to the digital education and peer support program.
|
Routine post-stroke care provided by the participating hospital, including standard discharge education and follow-up telephone contacts.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Unmet Needs
기간: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using the Unmet Needs Questionnaire for young stroke survivors
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Self-Efficacy
기간: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using the Chinese version of the Stroke Self-Efficacy Questionnaire
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
Depressive Symptoms
기간: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
Assessed using the Taiwanese Depression Questionnaire
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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WHOQOL-BREF Score
기간: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using the Taiwan version of the WHOQOL-BREF.
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
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Activities of Daily Living
기간: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using the Barthel Index.
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
|
|
Instrumental Activities of Daily Living
기간: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using the Lawton Instrumental Activities of Daily Living Scale.
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Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
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Return-to-Work Status
기간: 1 month, 3 months, 6 months, and 12 months after enrollment
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Assessed using a structured return-to-work questionnaire developed for this study.
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1 month, 3 months, 6 months, and 12 months after enrollment
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Wen-Yu Kuo, PhD, Chang Gung University of Science and Technology
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .