IMAGINE Study Protocol

NCT ID: NCT03434938

Last Updated: 2021-03-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 272 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-19
• Study Completion Date: 2021-06-30

Brief 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.

Detailed 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. 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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

MI Intervention

Standard geriatric rehabilitation combined with 4 MI sessions (within 72 hours from admission, within 6 days, at 1 week from the second session and pre-discharge, respectively). MI will be delivered by nurses trained through a certified MI course and additional group coaching sessions will be offered them throughout the study. Quality control of the MI sessions will be carried out using Motivational Interviewing Treatment Integrity (MITI) Code 3.1.1 through random video recording.

Group Type: EXPERIMENTAL

Motivational interviewing

Intervention Type: BEHAVIORAL

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.

Standard rehabilitation

Routine geriatric rehabilitation will include a multidisciplinary and individualized treatment plan based on comprehensive geriatric and specific rehabilitation assessments. As a specific control intervention, within 72 hours from admission a nurse without training in MI will handle the patient written information about generic benefits of exercising.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Older adults (>=60 years old).

2. Admitted to the geriatric rehabilitation hospital after a mild-moderate stroke (ischemic or hemorrhagic); stroke severity assessed by National Institute of Health Stroke Severity (NIHSS) scale <16 points.

3. Able to provide informed consent.

Exclusion Criteria

1. Previous diagnosis of dementia (ascertained from medical records).

2. Moderate-severe post-stroke cognitive impairment (Pfeiffer SMPQ>7 errors) or persistent delirium after 7 days from admission.

3. Previous severe disability in the activities of daily living (pre-stroke Barthel index <20/100 points).

4. Severe stroke which might limit recovery (NIHSS>=16).

5. Aphasia or other problems which limit communication and 6) advanced and terminal condition (prognosis not exceeding 6 months).

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vall d'Hebron Institute of Research

UNKNOWN

Sponsor Role: collaborator

Health and Ageing Foundation of the Autonomous University of Barcelona

UNKNOWN

Sponsor Role: collaborator

Center for Ageing and Supportive Environments

UNKNOWN

Sponsor Role: collaborator

Hospital Universitari de Santa Maria

UNKNOWN

Sponsor Role: collaborator

Consorci Sanitari Integral

OTHER

Sponsor Role: collaborator

Parc Sanitari Pere Virgili

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Fundació Salut i Envelliment Universitat Autònoma de Barcelona

Bellaterra, Barcelona, Spain

Site Status: ACTIVE_NOT_RECRUITING

Consorci Sanitari Integral - Hospital General de L'Hospitalet & Hospital de St Joan Despí

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status: RECRUITING

Parc Sanitari Pere Virgili

Barcelona, , Spain

Site Status: RECRUITING

Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron

Barcelona, , Spain

Site Status: ACTIVE_NOT_RECRUITING

Hospital Universitari Santa Maria

Lleida, , Spain

Site Status: RECRUITING

University of Lund

Lund, , Sweden

Site Status: ACTIVE_NOT_RECRUITING

Countries

Spain; Sweden

Central Contacts

Marco Inzitari, PhD

Role: CONTACT

minzitari@perevirgili.cat

932594102

Carmina Castellano-Tejedor, PhD

Role: CONTACT

ccastellano@perevirgili.cat

932594263

Facility Contacts

Benito Jesús Fontecha Gómez, MD

Role: primary

bfontecha@csi.cat

José María Santiago Bautista, MD

Role: backup

josemaria.santiago@sanitatintegral.org

Marco Inzitari, MD, PhD

Role: primary

minzitari@perevirgili.cat

Carmina Castellano-Tejedor, PhD

Role: backup

ccastellano@perevirgili.cat

Ana Belén Vena Martínez, MD, PhD

Role: primary

anav@gss.scs.es

References

Gual N, Perez LM, Castellano-Tejedor C, Lusilla-Palacios P, Castro J, Soto-Bagaria L, Coll-Planas L, Roque M, Vena AB, Fontecha B, Santiago JM, Lexell EM, Chiatti C, Iwarsson S, Inzitari M. 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. BMC Geriatr. 2020 Sep 4;20(1):321. doi: 10.1186/s12877-020-01694-6.

Reference Type: DERIVED

PMID: 32887564 (View on PubMed)

Other Identifiers

IMAGINE (ID 373 / 49)

Identifier Type: -

Identifier Source: org_study_id