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

NCT07725666 | Not Yet Recruiting

• 2 other identifiers: 202501542A3NSTC 115-2314-B-255-010-MY3
• Study Type: interventional
• Target: 148
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Stroke; Stroke (6 Months or More After Onset)

Keywords

Stroke; Digital Health; Peer Support

Outcome Measures

Primary Outcomes (1)

• Unmet Needs

  Assessed using the Unmet Needs Questionnaire for young stroke survivors

  Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

Secondary Outcomes (6)

• Self-Efficacy

  Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

• Depressive Symptoms

  Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

• WHOQOL-BREF Score

  Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

• Activities of Daily Living

  Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

• Instrumental Activities of Daily Living

  Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

Study Arms (2)

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

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.

Other: Usual Post-Stroke Care

Interventions

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.

Experimental

Usual Post-Stroke Care OTHER

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

Usual Care

Eligibility Criteria

• Age: 31 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chang Gung Memorial Hospital: lead

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Wen-Yu Kuo, PhD

  Chang Gung University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen-YU Kuo, PhD

CONTACT

+886-3-2118999; wykuo@mail.cgust.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants are informed that they will receive one of two post-stroke education programs but are not informed which program is the intervention. Research staff delivering the interventions and outcome assessors are blinded to treatment allocation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: July 24, 2026

Record last verified: 2026-07