IMAGINE Study Protocol

NCT03434938 | Unknown

• 1 other identifier: IMAGINE (ID 373 / 49)
• Study Type: interventional
• Target: 272
• Locations: 2 countries
• Sites: 6

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.

Conditions

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

Keywords

Stroke; Geriatric; Rehabilitation; Functional recovery; Physical activity; Motivational interviewing; Adherence; Clinical trial

Outcome Measures

Primary Outcomes (1)

• Change in Functional Independence Measure (FIM).

  The FIM is used to track functional evolution during in-hospital rehabilitation process. FIM is comprised of 18 items, grouped into 2 subscales: 1) motor and 2) cognition. The motor subscale includes: Eating, grooming, bathing, dressing (upper body), dressing (lower body), toileting, bladder management, bowel management, transfers (bed/chair/wheelchair), transfers (toilet), transfers (bath/shower), walk/wheelchair, stairs. The cognition subscale includes: Comprehension, expression, social interaction, problem solving, memory. The total score for the FIM instrument (the sum of the motor and cognition subscale scores) will be a value between 18 and 126. The higher the score, the more independent the patient is in performing the task associated with that item.

  At admission (within 72 hours), 30 days, and at 3 months follow-up.

Secondary Outcomes (13)

• Modified-Rankin Scale (mRS)

  At admission (within 72 hours; recall period, previous to event), and at 3 months follow-up.

• The Canadian Performance Oriented Measure (COPM).

  At 30 days from admission, and at 3 months follow-up.

• In-hospital physical activity.

  7 consecutive in-hospital days after admission, preferably within 10 days before discharge.

• Short Physical Performance Battery (SPPB).

  At admission (within 72 hours), 30 days, and at 3 months follow-up.

• Number of adverse events registration.

  At 30 days after admission, and at 3 months follow-up.

Other Outcomes (1)

• Participants perceptions and experiences of the intervention.

  At 30 days of hospitalization, and at 3 months follow-up.

Study Arms (2)

MI Intervention

EXPERIMENTAL

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.

Behavioral: Motivational interviewing

Standard rehabilitation

NO INTERVENTION

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.

Interventions

Motivational interviewing 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.

MI Intervention

Eligibility Criteria

• Age: 60 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Older adults (\>=60 years old).
• 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.
• Able to provide informed consent.

You may not qualify if:

• Previous diagnosis of dementia (ascertained from medical records).
• Moderate-severe post-stroke cognitive impairment (Pfeiffer SMPQ\>7 errors) or persistent delirium after 7 days from admission.
• Previous severe disability in the activities of daily living (pre-stroke Barthel index \<20/100 points).
• Severe stroke which might limit recovery (NIHSS\>=16).
• Aphasia or other problems which limit communication and 6) advanced and terminal condition (prognosis not exceeding 6 months).

Sponsors & Collaborators

• Parc Sanitari Pere Virgili: lead
• Vall d'Hebron Institute of Research: collaborator
• Health and Ageing Foundation of the Autonomous University of Barcelona: collaborator
• Center for Ageing and Supportive Environments: collaborator
• Hospital Universitari de Santa Maria: collaborator
• Consorci Sanitari Integral: collaborator

Study Sites (6)

Fundació Salut i Envelliment Universitat Autònoma de Barcelona

Bellaterra, Barcelona, 08192, Spain

ACTIVE NOT RECRUITING

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

L'Hospitalet de Llobregat, Barcelona, 08906, Spain

RECRUITING

Parc Sanitari Pere Virgili

Barcelona, 08023, Spain

RECRUITING

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

Barcelona, 08035, Spain

ACTIVE NOT RECRUITING

Hospital Universitari Santa Maria

Lleida, 25198, Spain

RECRUITING

University of Lund

Lund, Sweden

ACTIVE NOT RECRUITING

Related Publications (1)

• 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.

  PMID: 32887564 DERIVED

MeSH Terms

Conditions

Ischemia; Stroke; Motor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Behavior

Intervention Hierarchy (Ancestors)

Directive Counseling; Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services

Central Study Contacts

Marco Inzitari, PhD

CONTACT

932594102; minzitari@perevirgili.cat

Carmina Castellano-Tejedor, PhD

CONTACT

932594263; ccastellano@perevirgili.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: February 15, 2018
• Study Start: June 19, 2018
• Primary Completion: June 30, 2021
• Study Completion: June 30, 2021
• Last Updated: March 10, 2021

Record last verified: 2021-03

Locations

ES (5); SE (1)