IMAGINE Study Protocol

Summary

Background: Rehabilitation pathways are crucial to reduce stroke-related disability. Motivational Interviewing (MI), a centred-person intervention aimed to empower and motivate the patient, could be a resource to improve rehabilitation and its outcomes for older stroke survivors.

Objective: The IMAGINE project aims to assess the impact of MI associated to standard geriatric rehabilitation, on 30 days functional improvement measured by the Functional Independence Measure (FIM), compared to standard geriatric rehabilitation alone, in patients admitted to geriatric rehabilitation after a stroke. Secondary objectives will be to assess the impact on physical activity and performance, self-efficacy, sense of coherence, safety, cost-utility and participants' experience, plus functional status at 3 months.

Methods: Multicenter randomized clinical trial in three geriatric rehabilitation departments. Older adults after mild-moderate stroke without previous dementia, post-stroke severe cognitive impairment or delirium at admission, severe previous disability, aphasia or terminal conditions will be randomized into the control or the intervention group (136 per group, total N = 272). The control group will receive written information about the benefits of exercising, besides standard rehabilitation. The intervention group, in addition, will receive 4 sessions of MI by trained nurses. A shared tailored plan based on patients' goals, needs, preferences and capabilities will be agreed. Besides the FIM, in-hospital physical activity will be measured through accelerometers (activPAL) and secondary outcomes using internationally validated scales. As a complex intervention, a process evaluation and cost-utility assessments will be performed too.

Results: Final results are expected by end of 2020. Implications: This project aims to achieve impacts on functional status, disability and physical performance and behavioral (increasing physical activity) and psychological implications (on general self-efficacy and sense of coherence) through a non-pharmacological and likely accessible, acceptable and scalable intervention. Efficiency and value, based on costs/quality adjusted life years, will be assessed. Moreover, a reduction in post-stroke disability would have social benefits also for families and would reduce health and social care costs. In brief, advances will be in terms of a better rehabilitation process.

Conditions

• Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)

Interventions

BEHAVIORAL

Motivational interviewing

MI sessions' goals will to obtain patients' collaboration, creating a shared tailored approach to complement the individual geriatric rehabilitation plan, and reinforcing engagement and adherence at 3 months. All 20-minutes sessions will follow the logical sequence of MI by Rollnick and Millner (engaging, focusing, evoking and planning) in a semi-structured format to ensure homogeneity. Content will include: 1) Creating engagement with patients by exploring their preferences, values, goals, and their knowledge and expectations about rehabilitation and recovery, 2) enhancing motivation by evoking patients' strengths and abilities, 3) follow-up and reinforcement, and 4) adapting the plan to the improved abilities and to home setting after discharge.

Sponsors & Collaborators

• Vall d'Hebron Institute of Research

  collaborator UNKNOWN

• Health and Ageing Foundation of the Autonomous University of Barcelona

  collaborator UNKNOWN

• Center for Ageing and Supportive Environments

  collaborator UNKNOWN

• Hospital Universitari de Santa Maria

  collaborator UNKNOWN

• Consorci Sanitari Integral

  collaborator OTHER

• Parc Sanitari Pere Virgili

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

60 Years

Max Age

110 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2018-06-19

Primary Completion

2021-06-30

Completion

2021-06-30

Countries

• Spain
• Sweden

Study Locations