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

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, 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

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.

Keywords: Adherence; Clinical trial; Functional recovery; Geriatrics; Motivational interviewing; Physical activity; Rehabilitation; Stroke.

Conflict of interest statement

The authors declare that they have no competing financial or personal interests related to IMAGINE project. The funding source had no role in the design of this study and will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.

Figures

Fig. 1
Fig. 1
Logic model of IMAGINE project
Fig. 2
Fig. 2
Structure and main contents of MI sessions
Fig. 3
Fig. 3
Flow chart

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