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

21. juli 2026 oppdatert av: Chang Gung Memorial Hospital

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.

Studieoversikt

Detaljert beskrivelse

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).

Studietype

Intervensjonell

Registrering (Antatt)

148

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Nei

Beskrivelse

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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Trippel

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv komparator: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Unmet Needs
Tidsramme: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using the Unmet Needs Questionnaire for young stroke survivors
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Self-Efficacy
Tidsramme: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using the Chinese version of the Stroke Self-Efficacy Questionnaire
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Depressive Symptoms
Tidsramme: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using the Taiwanese Depression Questionnaire
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
WHOQOL-BREF Score
Tidsramme: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using the Taiwan version of the WHOQOL-BREF.
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Activities of Daily Living
Tidsramme: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using the Barthel Index.
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Instrumental Activities of Daily Living
Tidsramme: Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using the Lawton Instrumental Activities of Daily Living Scale.
Baseline, 1 month, 3 months, 6 months, and 12 months after enrollment
Return-to-Work Status
Tidsramme: 1 month, 3 months, 6 months, and 12 months after enrollment
Assessed using a structured return-to-work questionnaire developed for this study.
1 month, 3 months, 6 months, and 12 months after enrollment

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Wen-Yu Kuo, PhD, Chang Gung University of Science and Technology

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

1. august 2026

Primær fullføring (Antatt)

1. juli 2028

Studiet fullført (Antatt)

1. juli 2029

Datoer for studieregistrering

Først innsendt

21. juli 2026

Først innsendt som oppfylte QC-kriteriene

21. juli 2026

Først lagt ut (Faktiske)

24. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

24. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

21. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • 202501542A3
  • NSTC 115-2314-B-255-010-MY3 (Annet stipend/finansieringsnummer: National Science and Technology Council (NSTC), Taiwan)

Legemiddel- og utstyrsinformasjon, studiedokumenter

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Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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