Motivational Intervention for Older Adults Undergoing Inpatient Post-stroke Geriatric Rehabilitation and in Transition to Home
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 272
- 试验地点
- 11
- 主要终点
- Change in Functional Independence Measure (FIM).
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 60 Years 至 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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).
结局指标
主要结局
Change in Functional Independence Measure (FIM).
时间窗: 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.
次要结局
- Short Physical Performance Battery (SPPB).(At admission (within 72 hours), 30 days, and at 3 months follow-up.)
- Sense of coherence (SOC) questionnaire.(At 30 days after admission, and at 3 months follow-up.)
- Process variables - Length of hospital stay.(Through study completion, an average of 40 days.)
- Rehabilitation efficiency.(Through study completion, an average of 40 days.)
- The Canadian Performance Oriented Measure (COPM).(At 30 days from admission, and at 3 months follow-up.)
- Number of adverse events registration.(At 30 days after admission, and at 3 months follow-up.)
- Self-perceived pain: 10-point numeric scale(At 30 days after admission, and at 3 months follow-up.)
- Modified-Rankin Scale (mRS)(At admission (within 72 hours; recall period, previous to event), and at 3 months follow-up.)
- In-hospital physical activity.(7 consecutive in-hospital days after admission, preferably within 10 days before discharge.)
- Process variables - Destination at discharge.(Through study completion, an average of 40 days.)
- General Self-Efficacy scale (GSE).(At 30 days after admission, and at 3 months follow-up.)
- Process variables - Total time of rehabilitation.(Through study completion, an average of 40 days.)
- Cost-utility measures.(At admission (within 72 hours), 30 days, and at 3 months follow-up.)