NCT06582316

Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Protocol for Clinical Implementation

Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Sequential Multiple Assignment Randomised Trial (SMART) Protocol for Clinical Implementation

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 160 (estimated)
• Sponsor: National University of Singapore · Academic / Other
• Sex: All
• Age: 40 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Chronic Condition

Interventions

Type	Name	Description
OTHER	Brain Health Training Programme	"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.

Timeline

• Start date: 2025-04-02
• Primary completion: 2026-03-01
• Completion: 2026-06-01
• First posted: 2024-09-03
• Last updated: 2025-05-22

Locations

1 site across 1 country: Singapore