Digital Solution for Salutogenic Brain Health (DiSaB): a Pilot Protocol for Clinical Implementation
NCT Number: NCT06582316
Acronym: DiSaB
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Chronic Condition
Sponsor: National University of Singapore
Sex: ALL
Age: ADULT
Enrollment: 160
Study Design: Allocation: RANDOMIZED|Intervention Model: SEQUENTIAL|Masking: SINGLE (PARTICIPANT)|Primary Purpose: HEALTH_SERVICES_RESEARCH
Start Date: 2024-09
Completion Date: 2025-12

Summary:
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:

1. Does the DiSaB intervention improve participants' cognitive functions, health measures, and psychosocial health?
2. Is an individualised or group-based health education session better at improving cognitive, physical and psychosocial health in participants who did not respond to the DiSaB intervention?
3. How useful and practical is the DiSaB intervention, according to

   1. participants and
   2. nurses carrying out the intervention?

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

1. Complete cognitive assessments, questionnaires, and health tests before intervention, immediately after the intervention, and 6 months after the intervention
2. Either undergo no intervention, or undergo the DiSaB intervention over 2 months
3. Be randomly selected to attend focus group interviews

Local champions will complete questionnaires and attend focus group interviews after administering and/or co-facilitating the intervention.

Primary Outcome Measures: Change in heart rate, Heart rate will be measured on-site, 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 8/9)|Change in lipid levels, Information will be obtained from patients\&#39; HealthHub/Health Buddy/OneNUHS or other health apps, 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 8/9)|Change in HbA1c levels, Information will be obtained from patients\&#39; HealthHub/Health Buddy/OneNUHS or other health apps, 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 8/9)|Change in blood pressure, Blood pressure will be measured on-site, 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 8/9)|Change in SDMT scores, Symbol Digit Modality Test (SDMT). Total maximum score is 110. Higher scores indicate better cognitive performance., 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 8/9)|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., 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 8/9)|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., 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 8/9)|Change in psychosocial health 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., 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 8/9)|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., 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 8/9)|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., 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 8/9)|Patient satisfaction feedback questionnaire (patients), Completed online, 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. Intervention arm participants will be randomly chosen (n=6) to take part in the focus group interview., Final follow up (month 9-10)|Barriers and facilitators questionnaire (nurses), Completed online. The questionnaire will be administered multiple times throughout the study, at the specific time points as stated below., Baseline (month 0), weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm OR months 4-6 for control arm), final follow up (month 8/9)|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., Baseline (month 0), weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm OR months 4-6 for control arm), final follow up (month 8/9)|Effectiveness of DiSaB intervention questionnaire (patients), Using RE-AIM model; completed online. Questionnaire is given at multiple points throughout the study, as listed below., Once at the end of TYB intervention (month 3 for intervention arm, month 6 for control arm), once during final follow-up (month 8/9 for all participants)|Feedback from nurses using focus group interview, Questions are developed from RE-AIM model, Month 3 for intervention arm OR 6 for control arm (immediately after completion of 2-month-long TYB intervention)
Secondary Outcome Measures: Economic evaluation on the feasibility of DiSaB implementation using cost-effectiveness questionnaire, For evaluation of economics and further impact, Month 9