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Open Access 01-12-2020 | Stroke | Study protocol

IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors

Authors: Neus Gual, Laura Mónica Pérez, Carmina Castellano-Tejedor, Pilar Lusilla-Palacios, Judith Castro, Luís Soto-Bagaria, Laura Coll-Planas, Marta Roqué, Ana Belen Vena, Benito Fontecha, Jose M. Santiago, Eva Månsson Lexell, Carlos Chiatti, Susanne Iwarsson, Marco Inzitari

Published in: BMC Geriatrics | Issue 1/2020

Abstract

Background

Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), as a person-centered complex intervention, aimed to empower and motivate, and could be a resource to improve rehabilitation outcomes for older stroke survivors. The IMAGINE project aims to assess the impact of MI, as a complement to standard geriatric rehabilitation, on functional improvement at 30 days after admission, compared to standard geriatric rehabilitation alone, in persons admitted to geriatric rehabilitation after a stroke. Secondary objectives include assessing the impact of MI on physical activity and performance, self-efficacy, safety, cost-utility, participants’ experiences and functional status at 3 months.

Methods

We will conduct a multicenter randomized clinical trial in three geriatric rehabilitation hospitals in Spain. Older adults after mild-moderate stroke without previous severe cognitive impairment or disability will be randomized into the control or intervention group (136 per group, total N = 272). The intervention group will receive 4 sessions of MI by trained nurses, including the design of a personalized rehabilitation plan agreed between stroke survivors and nurses based on stroke survivors´ goals, needs, preferences and capabilities. Main outcome will be the Functional Independence Measure (FIM). In-hospital physical activity will be measured through accelerometers and secondary outcomes using validated scales. The study includes a process evaluation and cost-utility analysis.

Discussion

Final results are expected by end of 2020. This study will provide relevant information on the implementation of MI as a rehabilitation reinforcement tool in older stroke survivors. A potential reduction in post-stroke disability and dependence would increase person’s health-related quality of life and well-being and reduce health and social care costs. IMAGINE has the potential to inform practice and policymakers on how to move forward towards shared decision-making and shared responsibilities in the vulnerable population of older stroke survivors.

Trial registration

ClinicalTrials.gov: NCT03434938, registered on January 2018.

Available only for authorised users

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Title: IMAGINE study protocol of a clinical trial: a multi-center, investigator-blinded, randomized, 36-month, parallel-group to compare the effectiveness of motivational interview in rehabilitation of older stroke survivors
Authors: Neus Gual
Laura Mónica Pérez
Carmina Castellano-Tejedor
Pilar Lusilla-Palacios
Judith Castro
Luís Soto-Bagaria
Laura Coll-Planas
Marta Roqué
Ana Belen Vena
Benito Fontecha
Jose M. Santiago
Eva Månsson Lexell
Carlos Chiatti
Susanne Iwarsson
Marco Inzitari
Publication date: 01-12-2020
Publisher: BioMed Central
Keyword: Stroke
Published in: BMC Geriatrics / Issue 1/2020
Electronic ISSN: 1471-2318
DOI: https://doi.org/10.1186/s12877-020-01694-6

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