CClinicalTrials.gg
Not yet recruitingNCT07725666Updated Jul 24, 2026

Co-Designed Digital Education and Peer Support for Young and Middle-Aged Stroke Survivors

An interventional study of Patient-Centered Digital Education and Peer Support Program and Usual Post-Stroke Care in Stroke and Stroke (6 Months or More After Onset), sponsored by Chang Gung Memorial Hospital. Not yet recruiting. Open to participants aged 31 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-07-24.

Sponsored by Chang Gung Memorial Hospital · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
148
Allocation
Randomized
Ages
31 Years to 64 Years
Sex
All
01

Study 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. 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).

02

Conditions studied

  • Stroke
  • Stroke (6 Months or More After Onset)

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Keywords

  • Stroke
  • Digital Health
  • Peer Support
03

In context

Stroke

7,283 studies on the registry are indexed under Stroke; 2,013 are open to participants now.

This study's planned enrollment of 148 is above the median of 50 across 5,366 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Chang Gung Memorial Hospital is the lead sponsor of 1,064 studies on the registry; 235 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
31 Years to 64 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Outcomes assessor)
Enrollment
148 participants (estimated)

Study arms

  • Experimental
    Experimental

    Participants will receive a 12-month patient-centered digital education and peer support program

    Behavioral: Patient-Centered Digital Education and Peer Support Program

  • Active comparator
    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.

    Other: Usual Post-Stroke Care

Interventions

  • BehavioralPatient-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.

  • OtherUsual Post-Stroke Care

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

06

What researchers measure

Primary outcomes

  1. Unmet Needs

    Assessed using the Unmet Needs Questionnaire for young stroke survivors

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

Secondary outcomes

  1. Self-Efficacy

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

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

  2. Depressive Symptoms

    Assessed using the Taiwanese Depression Questionnaire

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

  3. WHOQOL-BREF Score

    Assessed using the Taiwan version of the WHOQOL-BREF.

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

  4. Activities of Daily Living

    Assessed using the Barthel Index.

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

  5. Instrumental Activities of Daily Living

    Assessed using the Lawton Instrumental Activities of Daily Living Scale.

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

  6. Return-to-Work Status

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

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

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Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07725666
Lead sponsor
Chang Gung Memorial Hospital
Responsible party
Sponsor
First posted
Jul 24, 2026
Start date
Aug 2026 (estimated)
Primary completion
Jul 2028 (estimated)
Completion
Jul 2029 (estimated)
Last update
Jul 24, 2026

Study contacts

Wen-YU Kuo, PhD
Contact
wykuo@mail.cgust.edu.tw
+886-3-2118999 ext. 3411
Wen-Yu Kuo, PhD
principal investigator · Chang Gung University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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