Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial

Introduction Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor a...

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Main Authors: Tsan-Hon Liou, Feng-Hang Chang, Valeria Chiu, Pengsheng Ni, Yen-Nung Lin, Jiunn-Horng Kang, Der-Sheng Han, Shih-Pin Hsu, Juleen Rodakowski
Format: Article
Language:English
Published: BMJ Publishing Group 2025-05-01
Series:BMJ Open
Online Access:https://bmjopen.bmj.com/content/15/5/e090751.full
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author Tsan-Hon Liou
Feng-Hang Chang
Valeria Chiu
Pengsheng Ni
Yen-Nung Lin
Jiunn-Horng Kang
Der-Sheng Han
Shih-Pin Hsu
Juleen Rodakowski
author_facet Tsan-Hon Liou
Feng-Hang Chang
Valeria Chiu
Pengsheng Ni
Yen-Nung Lin
Jiunn-Horng Kang
Der-Sheng Han
Shih-Pin Hsu
Juleen Rodakowski
author_sort Tsan-Hon Liou
collection DOAJ
description Introduction Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor and caregiver needs, are essential during the transition process. However, few interventions equally prioritise the outcomes of both survivors and caregivers. This study aims to evaluate the efficacy of a newly developed dyad-focused strategy training intervention in enhancing participation among stroke survivors and their caregivers.Methods and analysis This study employs a single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding. We aim to enrol 138 stroke survivor-caregiver dyads, randomly assigned in a 1:1 ratio to either the experimental intervention group or the control group. Both groups will receive their usual rehabilitation plus 45–60 min sessions of the intervention twice weekly for a total of 12 sessions. Outcome measures, including the Participation Measure-3 Domains, 4 Dimensions, General Self-Efficacy Scale and Activity Measure for Post-Acute Care, will be collected at baseline, post-intervention and at 3-month, 6-month and 12-month follow-ups. Data will be analysed using multiple linear regression and mixed-effects regression models. Qualitative indepth interviews with participants, caregivers and therapists will be conducted post intervention, transcribed and thematically analysed.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N202203083), National Taiwan University Hospital (approval number: 202207096RINA) and Taipei Tzu Chi Hospital (approval number: 11 M-107). Findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.Trial registration number NCT05571150; Preresults.
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spelling doaj-art-56460a654fc34c5fbebdad2e125057bc2025-08-20T03:47:33ZengBMJ Publishing GroupBMJ Open2044-60552025-05-0115510.1136/bmjopen-2024-090751Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trialTsan-Hon Liou0Feng-Hang Chang1Valeria Chiu2Pengsheng Ni3Yen-Nung Lin4Jiunn-Horng Kang5Der-Sheng Han6Shih-Pin Hsu7Juleen Rodakowski82 Department of Physical Medicine and Rehabilitation, Wan Fang Hospital, Taipei Medical University, Taipei, Taiwan1 Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan10 Department of Physical Medicine and Rehabilitation, Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation, Taipei, Taiwan9 Health Law, Policy & Management, Boston University School of Public Health, Boston, MA, USA1 Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan3 Department of Physical Medicine and Rehabilitation, Taipei Medical University Hospital, Taipei, Taiwan7 Department of Physical Medicine and Rehabilitation, College of Medicine, National Taiwan University, Taipei, Taiwan1 Graduate Institute of Injury Prevention and Control, College of Public Health, Taipei Medical University, Taipei, Taiwan11 Department of Occupational Therapy, University of Pittsburgh, Pittsburgh, Pennsylvania, USAIntroduction Stroke is a leading cause of death and disability worldwide. Stroke survivors and their caregivers often face profound social isolation and various participation restrictions, resulting in frustration and adverse health outcomes. Dyad-focused interventions, which address both survivor and caregiver needs, are essential during the transition process. However, few interventions equally prioritise the outcomes of both survivors and caregivers. This study aims to evaluate the efficacy of a newly developed dyad-focused strategy training intervention in enhancing participation among stroke survivors and their caregivers.Methods and analysis This study employs a single-blind, parallel-group randomised controlled trial with allocation concealment and assessor blinding. We aim to enrol 138 stroke survivor-caregiver dyads, randomly assigned in a 1:1 ratio to either the experimental intervention group or the control group. Both groups will receive their usual rehabilitation plus 45–60 min sessions of the intervention twice weekly for a total of 12 sessions. Outcome measures, including the Participation Measure-3 Domains, 4 Dimensions, General Self-Efficacy Scale and Activity Measure for Post-Acute Care, will be collected at baseline, post-intervention and at 3-month, 6-month and 12-month follow-ups. Data will be analysed using multiple linear regression and mixed-effects regression models. Qualitative indepth interviews with participants, caregivers and therapists will be conducted post intervention, transcribed and thematically analysed.Ethics and dissemination Ethics approval was obtained from the Ethics Committee of Taipei Medical University (approval number: N202203083), National Taiwan University Hospital (approval number: 202207096RINA) and Taipei Tzu Chi Hospital (approval number: 11 M-107). Findings will be disseminated through presentations at scientific conferences and publications in peer-reviewed journals.Trial registration number NCT05571150; Preresults.https://bmjopen.bmj.com/content/15/5/e090751.full
spellingShingle Tsan-Hon Liou
Feng-Hang Chang
Valeria Chiu
Pengsheng Ni
Yen-Nung Lin
Jiunn-Horng Kang
Der-Sheng Han
Shih-Pin Hsu
Juleen Rodakowski
Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial
BMJ Open
title Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial
title_full Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial
title_fullStr Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial
title_full_unstemmed Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial
title_short Enhancing dyadic outcomes of stroke survivors and caregivers: protocol for a randomised controlled trial
title_sort enhancing dyadic outcomes of stroke survivors and caregivers protocol for a randomised controlled trial
url https://bmjopen.bmj.com/content/15/5/e090751.full
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