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Not yet recruiting NCT07725666

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

No phase Interventional Stroke Stroke (6 Months or More After Onset)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patient-Centered Digital Education and Peer Support Program, Usual Post-Stroke Care.
Who it may be relevant to
Registry conditions: Stroke, Stroke (6 Months or More After Onset). Basic parameters: 31 years — 64 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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).

Interventions

  • Behavioral 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.
  • Other Usual Post-Stroke Care
    Routine post-stroke care provided by the participating hospital, including standard discharge education and follow-up telephone contacts.

Primary outcome measures

  • Unmet Needs [Time frame: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment]
Secondary outcome measures (6)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07725666 · 202501542A3 · NSTC 115-2314-B-255-010-MY3

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗