Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)IMAGINENCT03434938
IMAGINE Study Protocol
A study testing Motivational interviewing in people with Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points), run by Parc Sanitari Pere Virgili at 6 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 110 years
- Conditions the study is for
- Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)
- What is being tested?
- Motivational interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 272 participants
- Where
- 6 sitesin 2 countries
- Study dates
- 19 Jun 2018to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Spain5 sites, 3 recruiting
- Recruiting
Parc Sanitari Pere Virgili
Barcelona, 08023
Marco Inzitari, MD, PhD, minzitari@perevirgili.cat
Carmina Castellano-Tejedor, PhD, ccastellano@perevirgili.cat
- Active, not recruiting
Hospital Universitari Vall d'Hebron - Fundació Institut de Recerca Vall d'Hebron
Barcelona, 08035
- Active, not recruiting
Fundació Salut i Envelliment Universitat Autònoma de Barcelona
Bellaterra, Barcelona, 08192
- Recruiting
Consorci Sanitari Integral - Hospital General de L'Hospitalet & Hospital de St Joan Despí
L'Hospitalet de Llobregat, Barcelona, 08906
Benito Jesús Fontecha Gómez, MD, bfontecha@csi.cat
José María Santiago Bautista, MD, josemaria.santiago@sanitatintegral.org
- Recruiting
Hospital Universitari Santa Maria
Lleida, 25198
Ana Belén Vena Martínez, MD, PhD, anav@gss.scs.es
About this study
Official title: 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.
Read more
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.
Read the 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.
- Being tested
- Motivational interviewing
- Keywords
- Stroke, Geriatric, Rehabilitation, Functional recovery, Physical activity, Motivational interviewing, Adherence, Clinical trial
- Medical subject headings
- Ischemia, Stroke, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivational interviewingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At admission (within 72 hours), 30 days, and at 3 months follow-up.
Secondary outcomes (13)
Modified-Rankin Scale (mRS)
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".
Measured: At admission (within 72 hours; recall period, previous to event), and at 3 months follow-up.
The Canadian Performance Oriented Measure (COPM).
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).
Measured: At 30 days from admission, and at 3 months follow-up.
In-hospital physical activity.
This will be measured through accelerometers (ActivPAL) located at the preserved leg, to measure mainly time spent sitting and standing.
Measured: 7 consecutive in-hospital days after admission, preferably within 10 days before discharge.
Short Physical Performance Battery (SPPB).
Improvement in physical performance will be measured using the SPPB, including balance, strength and gait velocity sub-items.
Measured: At admission (within 72 hours), 30 days, and at 3 months follow-up.
Number of adverse events registration.
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.
Measured: At 30 days after admission, and at 3 months follow-up.
Self-perceived pain: 10-point numeric scale
Self-perceived pain will be assessed by means of a 10-point numeric scale (0 = no pain at all, 10 = worst possible pain).
Measured: At 30 days after admission, and at 3 months follow-up.
General Self-Efficacy scale (GSE).
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.
Measured: At 30 days after admission, and at 3 months follow-up.
Sense of coherence (SOC) questionnaire.
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).
Measured: At 30 days after admission, and at 3 months follow-up.
Process variables - Length of hospital stay.
Length of stay (total numer of days) for each patient will be measured considering as an endpoint patients' hospital discharge.
Measured: Through study completion, an average of 40 days.
Process variables - Destination at discharge.
Discharge destination (specifically: home, nursing home, long-term care, acute hospital, death) will be registered for each patient.
Measured: Through study completion, an average of 40 days.
Process variables - Total time of rehabilitation.
Total time of rehabilitation (total numer of days) will be registered for each patient.
Measured: Through study completion, an average of 40 days.
Cost-utility measures.
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.
Measured: At admission (within 72 hours), 30 days, and at 3 months follow-up.
Rehabilitation efficiency.
Rehabilitation efficiency scores for each patient will be computed as the improvement in the FIM/length of hospital stay.
Measured: Through study completion, an average of 40 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2018
- Study start19 Jun 2018
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 272 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Parc Sanitari Pere Virgili
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03434938
- Sponsor's protocol ID
- IMAGINE (ID 373 / 49)
- Acronym
- IMAGINE
- Status last verified
- Mar 2021
- First submitted
- 23 Jan 2018
- Last updated
- 10 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 32887564
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Motivational Intervention for Older Adults Undergoing Inpatient Post-stroke Geriatric Rehabilitation and in Transition to Home
- ClinicalTrials.gov ID
- NCT03434938
- Acronym / sponsor ID
- IMAGINE / IMAGINE (ID 373 / 49)
- Keywords
- Stroke, Geriatric, Rehabilitation, Functional recovery, Physical activity, Motivational interviewing, Adherence, Clinical trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 272 participants (estimated)
- Lead sponsor
- Parc Sanitari Pere VirgiliUniversity, hospital or other
- 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
- Study start
- 19 Jun 2018 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 15 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| MI Intervention | Experimental | Behavioral: Motivational interviewingStandard 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. |
Who may qualify
- Ages
- 60 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Motivational interviewingMI 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. | Behavioural | MI Intervention |
Primary outcome
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.
13 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2021.
- Derived from this study: PubMed 32887564Gual 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Motivational interviewing in people with Patients (>=60 Years Old) Suffering From Mild-moderate Stroke (Ischemic or Hemorrhagic, Stroke Severity Assessed by NIHSS <16 Points), run by Parc Sanitari Pere Virgili at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Spain, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marco Inzitari, PhD (932594102, minzitari@perevirgili.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Functional Independence Measure (FIM). (time frame: At admission (within 72 hours), 30 days, and at 3 months follow-up.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03434938, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2021.