---
title: IMAGINE Study Protocol
nct_id: NCT03434938
overall_status: UNKNOWN
phase: NA
sponsor: Parc Sanitari Pere Virgili
study_type: INTERVENTIONAL
primary_condition: Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)
countries: Spain, Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03434938.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03434938"
ct_last_update_post_date: 2021-03-10
last_seen_at: "2026-05-12T07:31:08.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# IMAGINE Study Protocol

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

**NCT ID:** [NCT03434938](https://clinicaltrials.gov/study/NCT03434938)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 272
- **Lead Sponsor:** Parc Sanitari Pere Virgili
- **Collaborators:** Vall d'Hebron Institute Research, Health and Ageing Foundation of the Autonomous University of Barcelona, Center for Ageing and Supportive Environments, Hospital Universitari Santa Maria, Spain, Consorci Sanitari Integral
- **Conditions:** Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)
- **Start Date:** 2018-06-19
- **Completion Date:** 2021-06-30
- **CT.gov Last Update:** 2021-03-10

## 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

- **Minimum age:** 60 Years
- **Maximum age:** 110 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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).
```

## Arms

- **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.
- **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.

## Primary Outcomes

- **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.

## Secondary Outcomes

- **Modified-Rankin Scale (mRS)** _(time frame: 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.)_
- **In-hospital physical activity.** _(time frame: 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.)_
- **Number of adverse events registration.** _(time frame: 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.)_
- **General Self-Efficacy scale (GSE).** _(time frame: 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.)_
- **Process variables - Length of hospital stay.** _(time frame: Through study completion, an average of 40 days.)_
- **Process variables - Destination at discharge.** _(time frame: Through study completion, an average of 40 days.)_
- **Process variables - Total time of rehabilitation.** _(time frame: 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.)_
- **Rehabilitation efficiency.** _(time frame: Through study completion, an average of 40 days.)_

## Locations (6)

- Fundació Salut i Envelliment Universitat Autònoma de Barcelona, Bellaterra, Barcelona, Spain — _ACTIVE_NOT_RECRUITING_
- Consorci Sanitari Integral - Hospital General de L'Hospitalet & Hospital de St Joan Despí, L'Hospitalet de Llobregat, Barcelona, Spain — _RECRUITING_
- Parc Sanitari Pere Virgili, Barcelona, Spain — _RECRUITING_
- Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron, Barcelona, Spain — _ACTIVE_NOT_RECRUITING_
- Hospital Universitari Santa Maria, Lleida, Spain — _RECRUITING_
- University of Lund, Lund, Sweden — _ACTIVE_NOT_RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.fundació salut i envelliment universitat autònoma de barcelona|bellaterra|barcelona|spain` — added _(2026-05-12)_
- `locations.consorci sanitari integral - hospital general de l'hospitalet & hospital de st joan despí|l'hospitalet de llobregat|barcelona|spain` — added _(2026-05-12)_
- `locations.parc sanitari pere virgili|barcelona||spain` — added _(2026-05-12)_
- `locations.hospital universitari vall d'hebron - fundació institut de recerca vall d'hebron|barcelona||spain` — added _(2026-05-12)_
- `locations.hospital universitari santa maria|lleida||spain` — added _(2026-05-12)_
- `locations.university of lund|lund||sweden` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03434938*  
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