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This study addresses the growing burden of stroke in Singapore and highlights the lack of rehabilitation services for return to work after stroke. Despite functional physical recovery, many stroke survivors experience persistent impairments that hinder return-to-work. To bridge this gap, the study will implement a community-based brain health programme targeting cognitive and vocational outcomes in stroke survivors. Caregivers will also be included due to their critical support role. The study will assess the intervention's feasibility, acceptability, and its impact on cognitive function, return-to-work, neuroplasticity, psychosocial health, fatigue, and self-care.
Stroke is the fourth leading cause of death and the leading cause of adult disability in Singapore. Statistics indicate a concerning rise in young stroke cases. The burden of stroke care is expected to increase exponentially, posing significant challenges to the healthcare system and society. Cognitive impairment after stroke has been documented in up to one-third of stroke survivors. These impairments may be subtle but persistent and progressive even after the stroke survivor appears to have made functional recovery in other areas. Existing services in Singapore for stroke survivors typically target physical and daily functioning outcomes with little focus on cognitive functioning. Moreover, there is a lack of services for stroke survivors who face difficulties in returning to work due to cognitive impairment even when they have achieved optimal physical recovery. An important assessment of a rehabilitation intervention programme is in examining whether it drives positive neuroplasticity, which leads to improved cognitive and functional outcomes. There is presently a dearth of literature in brain mechanisms underlying the impact of cognitive rehabilitation.
A community-based brain health intervention, the Train-Your-Brain Stroke Recovery Programme, will be delivered by registered clinical neuropsychologists. Designed to enhance cognitive function and return-to-work outcomes in stroke survivors with mild cognitive impairment, the intervention will be evaluated using a mixed-methods randomized controlled trial. Stroke survivors will be randomized 1:1 into either the intervention or control arm. Caregivers, given their critical support role, will also be recruited to participate in the study. Outcome measures include feasibility of intervention, acceptability of intervention, cognitive function, return-to-work outcomes, changes in biomarkers, neuroimaging findings, psychosocial health, fatigue, and self-care. Outcome measures will be conducted pre-intervention, post-intervention, and 6-month follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | Participants will undergo the group-based Train-Your-Brain Stroke Recovery Programme. |
|
| Control Arm | No Intervention | Participants will undergo treatment-as-usual from their respective treatment providers. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Train-Your-Brain (TYB) Stroke Recovery Programme | Other | The intervention involves a structured brain health programme delivered by clinical neuropsychologists in three phases: an initial needs assessment, a multi-session intervention, and follow-up support. Participants will receive assessments, attend group sessions covering topics such as lifestyle, mood, cognition, and return-to-work strategies, and be supported with workbooks and referrals to community services. The programme combines in-person and online formats. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of eligible/ineligible participants | Percentage of eligible/ineligible participants and reasons for ineligibility | Through study completion, an average of 6 months |
| Recruitment and attrition rates | Percentage of recruited participants and drop-outs | Through study completion, an average of 6 months |
| VasCog Screen Test | Test is comprised of a short-Montreal Cognitive Assessment (total score out of 12) and modified Symbol Digit Modalities Test (score calculated based on correct responses) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Vascular Dementia Battery | Participants will meet criteria for Mild Cognitive Impairment if there is 1 or more domain(s) with failure in at least 50% of tasks in domain | Baseline (pre-intervention) |
| National Institute of Neurological Disorders and Stroke - Canadian Stroke Network (NINDS-CSN) Stroke Protocol | A test battery comprised of cognitive tests that are measured against their respective normative scores | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Return-to-work Questionnaire (National Institute of Neurological Disorders and Stroke - Common Data Elements) | Survey questions of participants' work status before and after stroke with check-box responses | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Cost Effectiveness Analysis Questionnaire | Immediately after the intervention, 6-months follow-up |
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Inclusion Criteria (for stroke survivors):
Inclusion Criteria (for caregivers):
Exclusion Criteria (for stroke survivors):
Exclusion Criteria (for caregivers):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanhong Dong | Contact | 65-65168686 | nurdy@nus.edu.sg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National University of Singapore | Recruiting | Singapore | Singapore |
All collected and deidentified IPD
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| ID | Term |
|---|---|
| D020521 | Stroke |
| ID | Term |
|---|---|
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| Intervention fidelity | Intervention Fidelity Checklist (eNACT Group Facilitation Competency Checklist)
| During the intervention and immediately after the intervention |
| Qualitative interviews | Semi-structured interviews will be conducted with stroke survivors and family members to obtain feedback about their experiences of the intervention | Immediately after the intervention |
| Participants' acceptability of the intervention | Feedback forms provided after each intervention session rated on a 5-point response scale from Strongly Disagree to Strongly Agree | During the intervention |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - 10 | 5-point response scale from Excellent (5) to Poor (1) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Survey questions of participants' Mobility, Self-care, Usual activities, Pain/discomfort, and Anxiety/depression with check-box responses across five levels of severity, ranging from no problems to extreme problems. | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Fatigue Assessment Scale | 5-point response scale from Always (5) to Never (1) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Depression, Anxiety, Stress Scale | 3-point response scale from Did not apply to me at all (0) to Applied to me very much, or most of the time (3) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Zarit Burden Interview | 4-point response scale from Nearly Always (4) to Never (0) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Voils Domains Of Subjective Extent of Nonadherence | Survey questions on participants' extent and reasons for nonadherence with check-box responses (None of the time, A little of the time, Some of the time, Most of the time, Every time) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Blood Pressure Measurement | Measurement of participants' blood pressure reading | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up |
| Blood-Derived Neurotrophic Factor | Blood biomarker derived from participants' blood samples | Immediately after the intervention, 6-months follow-up |
| Functional near-infrared spectroscopy measurement | Measurement of oxyhaemoglobin (HbO2), deoxyheemoglobin (HbR), and regional oxygen saturation (rSO2) while participants undergo various cognitive tests (e.g. N-back Task, verbal fluency test, Stroop Task) | Immediately after the intervention, 6-months follow-up |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |