Clinical trial NCT03434938: IMAGINE Study Protocol
Official title: Motivational Intervention for Older Adults Undergoing Inpatient Post-stroke Geriatric Rehabilitation and in Transition to Home
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
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
Lead sponsor: Parc Sanitari Pere Virgili
Sponsor class: OTHER
Collaborators: name: Vall d'Hebron Institute of Research
name: Health and Ageing Foundation of the Autonomous University of Barcelona
name: Center for Ageing and Supportive Environments
name: Hospital Universitari de Santa Maria
name: Consorci Sanitari Integral
First posted: 2018-02-15
Enrollment: 272
Sex: ALL
Minimum age (years): 60
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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).

Primary outcomes:
measure: Change in Functional Independence Measure (FIM).
timeFrame: At admission (within 72 hours), 30 days, and at 3 months follow-up.
Secondary outcomes:
measure: Modified-Rankin Scale (mRS)
timeFrame: At admission (within 72 hours; recall period, previous to event), and at 3 months follow-up.
measure: The Canadian Performance Oriented Measure (COPM).
timeFrame: At 30 days from admission, and at 3 months follow-up.
measure: In-hospital physical activity.
timeFrame: 7 consecutive in-hospital days after admission, preferably within 10 days before discharge.
measure: Short Physical Performance Battery (SPPB).
timeFrame: At admission (within 72 hours), 30 days, and at 3 months follow-up.
measure: Number of adverse events registration.
timeFrame: At 30 days after admission, and at 3 months follow-up.
measure: Self-perceived pain: 10-point numeric scale
timeFrame: At 30 days after admission, and at 3 months follow-up.
measure: General Self-Efficacy scale (GSE).
timeFrame: At 30 days after admission, and at 3 months follow-up.
measure: Sense of coherence (SOC) questionnaire.
timeFrame: At 30 days after admission, and at 3 months follow-up.
measure: Process variables - Length of hospital stay.
timeFrame: Through study completion, an average of 40 days.
measure: Process variables - Destination at discharge.
timeFrame: Through study completion, an average of 40 days.
measure: Process variables - Total time of rehabilitation.
timeFrame: Through study completion, an average of 40 days.
measure: Cost-utility measures.
timeFrame: At admission (within 72 hours), 30 days, and at 3 months follow-up.
measure: Rehabilitation efficiency.
timeFrame: Through study completion, an average of 40 days.
Other outcomes:
measure: Participants perceptions and experiences of the intervention.
timeFrame: At 30 days of hospitalization, and at 3 months follow-up.
Locations:
city: Bellaterra
country: Spain
facility: Fundació Salut i Envelliment Universitat Autònoma de Barcelona
state: Barcelona
city: L'Hospitalet De Llobregat
country: Spain
facility: Consorci Sanitari Integral - Hospital General de L'Hospitalet & Hospital de St Joan Despí
state: Barcelona
city: Barcelona
country: Spain
facility: Parc Sanitari Pere Virgili
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron
city: Lleida
country: Spain
facility: Hospital Universitari Santa Maria
city: Lund
country: Sweden
facility: University of Lund
Study officials:
References:
citation: 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.