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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

Gual, Neus ; Pérez, Laura Mónica ; Castellano-Tejedor, Carmina ; Lusilla-Palacios, Pilar ; Castro, Judith ; Soto-Bagaria, Luís ; Coll-Planas, Laura ; Roqué, Marta ; Vena, Ana Belen and Fontecha, Benito , et al. (2020) In BMC Geriatrics 20(1).
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Adherence, Clinical trial, Functional recovery, Geriatrics, Motivational interviewing, Physical activity, Rehabilitation, Stroke
in
BMC Geriatrics
volume
20
issue
1
article number
321
publisher
BioMed Central (BMC)
external identifiers
  • pmid:32887564
  • scopus:85090507806
ISSN
1471-2318
DOI
10.1186/s12877-020-01694-6
language
English
LU publication?
yes
id
483f514f-c769-4f2f-8f7a-5b50ec59b51f
date added to LUP
2020-09-29 15:12:14
date last changed
2024-04-03 15:11:43
@article{483f514f-c769-4f2f-8f7a-5b50ec59b51f,
  abstract     = {{<p>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.</p>}},
  author       = {{Gual, Neus and Pérez, Laura Mónica and Castellano-Tejedor, Carmina and Lusilla-Palacios, Pilar and Castro, Judith and Soto-Bagaria, Luís and Coll-Planas, Laura and Roqué, Marta and Vena, Ana Belen and Fontecha, Benito and Santiago, Jose M. and Lexell, Eva Månsson and Chiatti, Carlos and Iwarsson, Susanne and Inzitari, Marco}},
  issn         = {{1471-2318}},
  keywords     = {{Adherence; Clinical trial; Functional recovery; Geriatrics; Motivational interviewing; Physical activity; Rehabilitation; Stroke}},
  language     = {{eng}},
  number       = {{1}},
  publisher    = {{BioMed Central (BMC)}},
  series       = {{BMC Geriatrics}},
  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}},
  url          = {{http://dx.doi.org/10.1186/s12877-020-01694-6}},
  doi          = {{10.1186/s12877-020-01694-6}},
  volume       = {{20}},
  year         = {{2020}},
}