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NCT Number: NCT07725666

Co-Designed Digital Education and Peer Support for 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.

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Key information

Age range

31 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Patient-Centered Digital Education and Peer Support Program

Behavioral

A 12-month patient-centered digital education and peer support program delivered through LINE communities and Google collaborative platforms.

Usual Post-Stroke Care

Other

Routine post-stroke care provided by the participating hospital, including standard discharge education and follow-up telephone contacts.

Primary outcomes

  1. 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

Secondary outcomes

  1. Self-Efficacy

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

    Assessed using the Chinese version of the Stroke Self-Efficacy Questionnaire

  2. Depressive Symptoms

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

    Assessed using the Taiwanese Depression Questionnaire

  3. WHOQOL-BREF Score

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

    Assessed using the Taiwan version of the WHOQOL-BREF.

  4. Activities of Daily Living

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

    Assessed using the Barthel Index.

  5. Instrumental Activities of Daily Living

    Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

    Assessed using the Lawton Instrumental Activities of Daily Living Scale.

  6. Return-to-Work Status

    Time frame: 1 month, 3 months, 6 months, and 12 months after enrollment

    Assessed using a structured return-to-work questionnaire developed for this study.

Study contacts

Contact information is provided by the study sponsor or research team.

Wen-YU Kuo, PhD

CONTACT

[email protected]

+886-3-2118999 ext. 3411

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

A Co-Designed Digital Education and Peer Support Intervention for Reducing Unmet Needs and Enhancing Recovery Among Young and Middle-Aged Stroke Survivors

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Jul 24, 2026
Registry last updated
Jul 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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