A Pilot Return-to-Work Cognitive Intervention After Stroke

NCT07116187 | Recruiting

• 1 other identifier: NUS-IRB-2025-223
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Cognition; Return-to-work; Rehabilitation; Intervention; Community; Stroke survivors; Caregivers

Outcome Measures

Primary Outcomes (18)

• 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

• Intervention fidelity

  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

  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

Secondary Outcomes (1)

• Cost Effectiveness Analysis Questionnaire

  Immediately after the intervention, 6-months follow-up

Study Arms (2)

Intervention Arm

EXPERIMENTAL

Participants will undergo the group-based Train-Your-Brain Stroke Recovery Programme.

Other: Train-Your-Brain (TYB) Stroke Recovery Programme

Control Arm

NO INTERVENTION

Participants will undergo treatment-as-usual from their respective treatment providers.

Interventions

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.

Intervention Arm

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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
• Less than 21 years old
• Unable to provide informed consent
• Refuse recording
• Not staying with or not having knowledge of the stroke survivor's functioning
• Major psychiatric illnesses
• Not able to understand and converse in English

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University of Singapore

Singapore, Singapore

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Yanhong Dong

CONTACT

65-65168686; nurdy@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: August 11, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 26, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)