IMAGINE Study Protocol (IMAGINE)

March 9, 2021 updated by: Parc Sanitari Pere Virgili

Motivational Intervention for Older Adults Undergoing Inpatient Post-stroke Geriatric Rehabilitation and in Transition to Home

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

272

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08023
        • Recruiting
        • Parc Sanitari Pere Virgili
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marco Inzitari, MD, PhD
        • Sub-Investigator:
          • Neus Gual Tarrada, MD
        • Sub-Investigator:
          • Laura Mónica Pérez Bazán, MD, PhD
        • Sub-Investigator:
          • Judit Castro Díez
        • Sub-Investigator:
          • Luis Ignacio Soto Bagaria
        • Sub-Investigator:
          • Carmina Castellano Tejedor, PhD
      • Barcelona, Spain, 08035
        • Active, not recruiting
        • Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron
      • Lleida, Spain, 25198
        • Recruiting
        • Hospital Universitari Santa María
        • Contact:
    • Barcelona
      • Bellaterra, Barcelona, Spain, 08192
        • Active, not recruiting
        • Fundació Salut i Envelliment Universitat Autònoma de Barcelona
      • L'Hospitalet De Llobregat, Barcelona, Spain, 08906
  • Sweden
      • Lund, Sweden
        • Active, not recruiting
        • University of Lund

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 110 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Functional Independence Measure (FIM).
Time Frame: At admission (within 72 hours), 30 days, and at 3 months follow-up.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified-Rankin Scale (mRS)
Time Frame: At admission (within 72 hours; recall period, previous to event), and at 3 months follow-up.
The Modified Rankin Scale (mRS) assesses disability in post-stroke patients and it can be used to track functional evolution over time. A score of 0 is "no disability", 5 is "disability requiring constant care for all needs" and 6 is "death".
At admission (within 72 hours; recall period, previous to event), and at 3 months follow-up.
The Canadian Performance Oriented Measure (COPM).
Time Frame: At 30 days from admission, and at 3 months follow-up.
The COPM is a semi-structure interview that enables patient to identify problems and priorities in the three areas of occupational performance: self-care, productivity, and leisure. Once problems have been identify, patient needs to rate them using a 10-point scale. Then, patient will need to pick up to 5 most important problems to work. Finally, two subscale scores are obtained: performance (COPM-P) and satisfaction with performance (COPM-S).
At 30 days from admission, and at 3 months follow-up.
In-hospital physical activity.
Time Frame: 7 consecutive in-hospital days after admission, preferably within 10 days before discharge.
This will be measured through accelerometers (ActivPAL) located at the preserved leg, to measure mainly time spent sitting and standing.
7 consecutive in-hospital days after admission, preferably within 10 days before discharge.
Short Physical Performance Battery (SPPB).
Time Frame: At admission (within 72 hours), 30 days, and at 3 months follow-up.
Improvement in physical performance will be measured using the SPPB, including balance, strength and gait velocity sub-items.
At admission (within 72 hours), 30 days, and at 3 months follow-up.
Number of adverse events registration.
Time Frame: At 30 days after admission, and at 3 months follow-up.
The incidence of diverse adverse events will be registered (yes vs. no; and number of times occuring each incident). Variables collected are: Falls, fractures, cranial traumatism, cardiovascular events (specifically: angina, myocardial infarction, TIA, stroke), aspiration pneumonia/respiratory infections, readmissions to acute hospitals and death. A final composite (total number of adverse events for each patient) will be obtained.
At 30 days after admission, and at 3 months follow-up.
Self-perceived pain: 10-point numeric scale
Time Frame: At 30 days after admission, and at 3 months follow-up.
Self-perceived pain will be assessed by means of a 10-point numeric scale (0 = no pain at all, 10 = worst possible pain).
At 30 days after admission, and at 3 months follow-up.
General Self-Efficacy scale (GSE).
Time Frame: At 30 days after admission, and at 3 months follow-up.
The GSE is a 10-item tool designed to assess optimistic self-beliefs to cope with a variety of difficult demands in life. This scale is correlated to emotion, optimism and work satisfaction. Negative coefficients are found for depression, stress, health complaints, burnout, and anxiety. The total score is calculated by finding the sum of the all items. For the GSE, the total score ranges between 10 and 40, with a higher score indicating more self-efficacy.
At 30 days after admission, and at 3 months follow-up.
Sense of coherence (SOC) questionnaire.
Time Frame: At 30 days after admission, and at 3 months follow-up.
SOC-13 has three components: Comprehensibility, Manageability and Meaningfulness. This scale is rated on a 7-point likert scale, a total score can also be used. The mean alpha of the SOC-13 scale was .82 (range = .74 - .81).
At 30 days after admission, and at 3 months follow-up.
Process variables - Length of hospital stay.
Time Frame: Through study completion, an average of 40 days.
Length of stay (total numer of days) for each patient will be measured considering as an endpoint patients' hospital discharge.
Through study completion, an average of 40 days.
Process variables - Destination at discharge.
Time Frame: Through study completion, an average of 40 days.
Discharge destination (specifically: home, nursing home, long-term care, acute hospital, death) will be registered for each patient.
Through study completion, an average of 40 days.
Process variables - Total time of rehabilitation.
Time Frame: Through study completion, an average of 40 days.
Total time of rehabilitation (total numer of days) will be registered for each patient.
Through study completion, an average of 40 days.
Cost-utility measures.
Time Frame: At admission (within 72 hours), 30 days, and at 3 months follow-up.

Cost-utility will be measured as the ratio between direct costs during hospitalization (considering costs that include workforce time use, exams, use of other hospital resources, visits) and Quality Adjusted Life Years (QALYs) obtained by means of the EQoL-5D administered before and after the treatment.

Cost-utility will be calculated as the incremental ratio €/QALYs in the intervention vs. control group.
At admission (within 72 hours), 30 days, and at 3 months follow-up.
Rehabilitation efficiency.
Time Frame: Through study completion, an average of 40 days.
Rehabilitation efficiency scores for each patient will be computed as the improvement in the FIM/length of hospital stay.
Through study completion, an average of 40 days.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participants perceptions and experiences of the intervention.
Time Frame: At 30 days of hospitalization, and at 3 months follow-up.
Qualitative evaluation will be aimed to explore participant's experiences in the frame of the process evaluation of the intervention. Process evaluation will be based on MRC guidance, and will focus on how the context, implementation and impact mechanisms will influence the results. In particular, participants' experiences, their perceived impacts as well as unexpected effects will be explored through in-depth interviews at 30 days and at 3 months on a purposeful sample of participants, selected to maximize variability (by gender, disability levels, socio-economic levels, and social support). In addition, a purposeful sample of caregivers and professionals who performed the intervention will be also interviewed and we will conduct a focus group with reference professionals of the wards.
At 30 days of hospitalization, and at 3 months follow-up.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Parc Sanitari Pere Virgili

Collaborators

Consorci Sanitari Integral
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 19, 2018

Primary Completion (Anticipated)

June 30, 2021

Study Completion (Anticipated)

June 30, 2021

Study Registration Dates

First Submitted

January 23, 2018

First Submitted That Met QC Criteria

February 14, 2018

First Posted (Actual)

February 15, 2018

Study Record Updates

Last Update Posted (Actual)

March 10, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IMAGINE (ID 373 / 49)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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