IMAGINE Study Protocol
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: MI intervention will be associated to standard geriatric rehabilitation. MI will be structured in 4 sessions (within 72 hours from admission, within next 6 days after first MI session, at 1 week from the second session and pre-discharge), with the goals of reducing disability obtaining patients' collaboration, creating a shared tailored plan which would complement the individual approach established by the multidisciplinary team as part of routine geriatric rehabilitation unit, and reinforcing engagement and adherence at 3 months. Standard rehabilitation and control includes a multidisciplinary and individualized treatment plan based on comprehensive geriatric and specific rehabilitation assessments.Masking: Triple (Participant, Investigator, Outcomes Assessor)Masking Description: After inclusion in the study and obtaining informed consent, participants will be randomized to intervention or control group in a concealed allocation manner. Centralized randomization will be conducted through a block randomization procedure, with random-varying block size, stratified by participating centre. Participants will be randomized after the baseline assessment, guaranteeing the blinded assessment. The 30 days and 3 months assessments will be conducted by an assessor blinded to participants' group allocation, who will ask the participants not to disclose their group allocation. Afterwards, the assessor will record whether he/she was made aware of the participant allocation.Primary Purpose: Prevention
Participation Requirements
- Age
- Between 60 years and 110 years
- Gender
- Both males and females
Description
IMAGINE project aims to investigate the effect of adding an adapted MI approach to the usual geriatric rehabilitation to motivate and empower stroke patients to participate in their own rehabilitation plan and thus, to increase their physical activity and engagement in self-care and other activities...
IMAGINE project aims to investigate the effect of adding an adapted MI approach to the usual geriatric rehabilitation to motivate and empower stroke patients to participate in their own rehabilitation plan and thus, to increase their physical activity and engagement in self-care and other activities. The main aim is to finally improve patients' physical and global function and, in turn, to reduce dependency. As mentioned, there is evidence-base around MI in rehabilitation, which covers functional, clinical and efficiency aspects. It is expected that IMAGINE project will add a relevant contribution for the implementation of this intervention in older adults with post-stroke residual disability and dependency needing rehabilitation. Accordingly, this study should inform practice and policy on how to move forward towards shared decision making and shared responsibilities in a vulnerable population such as older adults with a recent stroke.
Tracking Information
- NCT #
- NCT03434938
- Collaborators
- Vall d'Hebron Institute of Research
- Health and Ageing Foundation of the Autonomous University of Barcelona
- Center for Ageing and Supportive Environments
- Hospital Universitari de Santa Maria
- Consorci Sanitari Integral
- Investigators
- Not Provided
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