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
Por:
Gual N., Pérez L.M., Castellano-Tejedor C., Lusilla-Palacios P., Castro J., Soto-Bagaria L., Coll-Planas L., Roqué M., Vena A.B., Fontecha B., Santiago J.M., Lexell E.M., Chiatti C., Iwarsson S., Inzitari M.
Publicada:
1 ene 2020
Resumen:
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. © 2020 The Author(s).
Filiaciones:
Gual N.:
REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron, Institute of Research, Barcelona, Spain
Pérez L.M.:
REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron, Institute of Research, Barcelona, Spain
Castellano-Tejedor C.:
REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron, Institute of Research, Barcelona, Spain
Autonomous University of Barcelona, Bellaterra, Spain
Lusilla-Palacios P.:
Psychiatry Department, University Hospital Vall d'Hebron, Barcelona, Spain
Castro J.:
REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron, Institute of Research, Barcelona, Spain
Soto-Bagaria L.:
REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron, Institute of Research, Barcelona, Spain
Coll-Planas L.:
Fundació Salut i Envelliment (Foundation on Health and Ageing), Universitat Autònoma de Barcelona, Barcelona, Spain
Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain
Roqué M.:
Fundació Salut i Envelliment (Foundation on Health and Ageing), Universitat Autònoma de Barcelona, Barcelona, Spain
Institute of Biomedical Research (IIB Sant Pau), Barcelona, Spain
Vena A.B.:
University Hospital Santa Maria, Lleida, Spain
Fontecha B.:
Hospital General de l'Hospitalet (Consorci Sanitari Integral), Hospitalet de Llobregat, Spain
Santiago J.M.:
Hospital General de l'Hospitalet (Consorci Sanitari Integral), Hospitalet de Llobregat, Spain
Lexell E.M.:
Department of Health Sciences, Lund University, Lund, Sweden
Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund-Malmö, Sweden
Chiatti C.:
Department of Health Sciences, Lund University, Lund, Sweden
Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund-Malmö, Sweden
Iwarsson S.:
Department of Health Sciences, Lund University, Lund, Sweden
Department of Neurology and Rehabilitation Medicine, Skåne University Hospital, Lund-Malmö, Sweden
Inzitari M.:
REFiT BCN Research Group-Parc Sanitari Pere Virgili-Vall d'Hebron, Institute of Research, Barcelona, Spain
Autonomous University of Barcelona, Bellaterra, Spain
Green Published, gold, Gold, Green
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