Stroke
Conditions
Keywords
Cognition, Return-to-work, Rehabilitation, Intervention, Community, Stroke survivors, Caregivers
Brief summary
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.
Detailed description
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.
Interventions
OTHERTrain-Your-Brain (TYB) Stroke Recovery Programme
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.
Sponsors
National University of Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
(for stroke survivors): * Between 21 to 65 years old * Ability to provide informed consent * Consent to recording / photo-taking * Living in the community with at least three months after stroke * Looking to return to work or switch jobs after stroke * No significant aphasia or physical disability issues which will impede them from performing cognitive tasks in the interventions and assessments * No major psychiatric illnesses * Able to understand and converse in English * Score on MoCA ≤22 and/or SDMT ≤13 (for those educated ≤6 years) or SDMT ≤32 (for those educated \>6 years) * Meet criteria for Mild Cognitive Impairment based on the Vascular Dementia Battery Inclusion Criteria (for caregivers): * At least 21 years old * Ability to provide informed consent * Consent to recording / photo-taking * Staying with or having knowledge of the stroke survivor's functioning * No major psychiatric illnesses * Able to understand and converse in English
Exclusion criteria
(for stroke survivors): * Less than 21 years old * More than 65 years old * Unable to provide informed consent * Refuse recording * Not living in the community and having less than three months after stroke * Significant aphasia or physical disability issues which will impede them from performing cognitive tasks in the interventions and assessments * Major psychiatric illnesses * Not able to understand and converse in English
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Functional near-infrared spectroscopy measurement | Immediately after the intervention, 6-months follow-up | 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) |
| Number of eligible/ineligible participants | Through study completion, an average of 6 months | Percentage of eligible/ineligible participants and reasons for ineligibility |
| Recruitment and attrition rates | Through study completion, an average of 6 months | Percentage of recruited participants and drop-outs |
| VasCog Screen Test | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 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) |
| Vascular Dementia Battery | Baseline (pre-intervention) | 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 |
| National Institute of Neurological Disorders and Stroke - Canadian Stroke Network (NINDS-CSN) Stroke Protocol | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | A test battery comprised of cognitive tests that are measured against their respective normative scores |
| Return-to-work Questionnaire (National Institute of Neurological Disorders and Stroke - Common Data Elements) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | Survey questions of participants' work status before and after stroke with check-box responses |
| Intervention fidelity | During the intervention and immediately after the intervention | Intervention Fidelity Checklist (eNACT Group Facilitation Competency Checklist) * Observed - Done well and Observed - Done adequately is equivalent to a score of 2; Observed - Not done well is equivalent to a score of 1; Not observed - despite opportunity is equivalent to a score of 0 * An overall score of 2 reflects adequate competence in group facilitation |
| Qualitative interviews | Immediately after the intervention | Semi-structured interviews will be conducted with stroke survivors and family members to obtain feedback about their experiences of the intervention |
| Participants' acceptability of the intervention | During the intervention | Feedback forms provided after each intervention session rated on a 5-point response scale from Strongly Disagree to Strongly Agree |
| Patient-Reported Outcomes Measurement Information System (PROMIS) - 10 | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 5-point response scale from Excellent (5) to Poor (1) |
| EuroQol 5-Dimension 5-Level (EQ-5D-5L) | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 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. |
| Fatigue Assessment Scale | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 5-point response scale from Always (5) to Never (1) |
| Depression, Anxiety, Stress Scale | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 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) |
| Zarit Burden Interview | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 4-point response scale from Nearly Always (4) to Never (0) |
| Voils Domains Of Subjective Extent of Nonadherence | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | 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) |
| Blood Pressure Measurement | Baseline (pre-intervention), immediately after the intervention, 6-months follow-up | Measurement of participants' blood pressure reading |
| Blood-Derived Neurotrophic Factor | Immediately after the intervention, 6-months follow-up | Blood biomarker derived from participants' blood samples |
Secondary
| Measure | Time frame |
|---|---|
| Cost Effectiveness Analysis Questionnaire | Immediately after the intervention, 6-months follow-up |
Countries
Singapore
Contacts
Primary ContactYanhong Dong
Outcome results
None listed