A Pilot Return-to-Work Cognitive Intervention After Stroke
- Conditions
- Stroke
- Registration Number
- NCT07116187
- Lead Sponsor
- National University of Singapore
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Recruitment and attrition rates Through study completion, an average of 6 months Percentage of recruited participants and drop-outs
Fatigue Assessment Scale Baseline (pre-intervention), immediately after the intervention, 6-months follow-up 5-point response scale from Always (5) to Never (1)
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
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)
Blood-Derived Neurotrophic Factor Immediately after the intervention, 6-months follow-up Blood biomarker derived from participants' blood samples
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
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
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
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 facilitationQualitative 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
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)
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.
- Secondary Outcome Measures
Name Time Method Cost Effectiveness Analysis Questionnaire Immediately after the intervention, 6-months follow-up