An interventional study of Brain Health Training Programme in Chronic Condition, sponsored by National University of Singapore. Recruiting at 1 site in Singapore. Open to participants aged 40 Years to 64 Years. Per ClinicalTrials.gov, last updated 2025-05-22.
Sponsored by National University of Singapore · Not applicable, Interventional, and Health services research
The goal of this clinical trial is to develop and learn if a digitally delivered brain health intervention (DiSaB) can help improve cognitive, physical and psychosocial health in middle-aged adults with chronic conditions at-risk for cognitive decline. The clinical trial also aims to find out the push and pull factors of implementing the intervention in primary care settings. The main questions it aims to answer are:
How useful and practical is the DiSaB intervention, according to
The investigators will compare a DiSaB intervention to a control condition (where participants do not undergo any intervention) to see if the DiSaB intervention works in improving participants' health.
The investigators will also compare individualised versus group health education sessions to see which session is better at improving the health of participants who did not respond to the DiSaB intervention.
Participants will
Local champions will complete questionnaires and attend focus group interviews after administering and/or co-facilitating the intervention.
The effectiveness of the DiSaB intervention implementation at primary care setting amongst participants with long term conditions will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model.
Secondly, the barriers and facilitators to DiSaB implementation amongst local champions [e.g., advanced practice nurses (APNs)] will be determined. Specifically, using the Capability, Opportunity, Motivation and Behavior (COM-B) model, the investigators will evaluate the barriers and facilitators towards DiSaB intervention implementation among healthcare professionals.
Third, sequential multiple assignment randomised trial (SMART) study design will also be employed in this study for the development of dynamic treatment regimens (DTRs) tailored for individual needs. The investigators first aim to evaluate the feasibility and compare the efficacy of additional individual intervention (i.e. a health education individual feedback session within 1 - 2 months) vs a smaller group intervention (i.e. health education group sessions over 3 months, once per month) post-standard TYB intervention amongst non-responders, in improving cognitive functions and management of their long-term conditions. Finally, the investigators will compare two embedded DTRs in the SMART, namely, (1) standard TYB followed by individualised health education session for non-responders and usual care for responders, and (2) standard TYB followed by group health education session for non-responders and usual care for responders.
Lastly, an economic evaluation will be carried out to evaluate cost-effectiveness and further impacts of the DiSaB implementation.
990 studies on the registry are indexed under Chronic Disease; 178 are open to participants now.
This study's planned enrollment of 160 is above the median of 120 across 722 interventional studies indexed under Chronic Disease.
Browse Chronic Disease studies →National University of Singapore is the lead sponsor of 206 studies on the registry; 52 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will undergo 8 sessions of digital "Train Your Brain" programme lead by a trained clinical neuropsychologist over 2 months.
Other: Brain Health Training Programme
Participants will not undergo any sessions of digital "Train Your Brain" programme for 2 months when intervention arm's brain health training programme is ongoing.
"Train Your Brain (TYB)" - group-based cognitive intervention programme for mild cognitive impairments. This programme equips participants with knowledge on cognition and brain health, provide cognitive coping strategies and boost their confidence and maintain independence in daily activities.
Change in heart rate
Heart rate will be measured on-site
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Change in lipid levels
Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
Change in HbA1c levels
Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in blood pressure
Blood pressure will be measured on-site
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in SDMT scores
Symbol Digit Modality Test (SDMT). Total maximum score is 110. Higher scores indicate better cognitive performance.
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in psychosocial health measured by DaSS-21
Depression, Anxiety and Stress Scale -21 item (DASS-21) Physical or online. There are 21 questions that are scored from 0 to 3, and the highest possible score is 63. Higher scores indicate poorer psychological health.
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in MoCA scores
Montreal Cognitive Assessment (MoCA). Total possible score is 30 (scoring is on the MoCA form itself), and a score of at least 26 indicates normal cognition. Higher scores indicate better cognition.
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in quality of life measured by EQ-5D-5L
EuroQol 5 Dimension 5 Level (EQ-5D-5L) Physical or online. Each question is scored from 1 to 5, with 1 indicating no problems in that dimension and 5 indicating total inability to perform in that dimension.
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in psychosocial health measured by AD8
Alzheimer's Disease-8 Component (AD8) Physical or online. There are a total of 8 questions asking about thinking ability, and each answer is coded 1 (yes, change present) or 0 (no change). 0 or 1 indicates normal cognition, and a score of at least 2 suggests that cognition issues might be present.
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Change in psychosocial health measured by Self-care of chronic illness inventory
Physical or online. 29 questions in total, answers are scored from 1 to 5. Higher scores indicate better self-care. When referencing standard scores, a standard score of 70 is the cut-off point for self-care adequacy.
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)
Patient satisfaction feedback questionnaire (patients)
Completed online
Time frame: Weekly (right after each TYB intervention) for 2 months. Also after health education sessions: either once [individual session] OR monthly for 3 months [group session]; during months 4-6) - intervention arm non-responders only
Feedback from patients using focus group interview
Questions are developed from RE-AIM model. Participants will be randomly chosen (n=30) to take part in the focus group interview.
Time frame: Final follow up (month 9/12)
Effectiveness of TYB intervention questionnaire (nurses)
Using RE-AIM model; completed online. Questionnaire will be given at multiple time points throughout the study, as listed below.
Time frame: Weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm and months 4-6 for control arm), final follow up (month 12)
Effectiveness of DiSaB intervention questionnaire (patients)
Using RE-AIM model; completed online. Questionnaire is given at multiple points throughout the study, as listed below.
Time frame: Once at the end of TYB intervention (month 3 for intervention arm, month 6 for control arm), once during final follow-up (month 9/12 for all participants)
Feedback from nurses using focus group interview
Questions are developed from RE-AIM model
Time frame: Month 6 (immediately after completion of 2-month-long TYB intervention control arm)
Economic evaluation on the feasibility of DiSaB implementation using cost-effectiveness questionnaire
For evaluation of economics and further impact
Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)
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National University of Singapore