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
National University of Singapore
160 participants
Apr 2, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- Aged 40 - 55 years old
- Have hypertension, hyperlipidaemia and/or type-2 diabetes
- Ability to provide written informed consent
- Posses sufficient English language skills in reading, writing and speaking
- Multimorbidity conditions are also acceptable with the exception of life-threatening co-morbidities with life expectancy of less than one year
- Total Risk Score (TRS) for cognitive impairment of at least 3
Exclusion Criteria6
- Physical, visual and/or hearing impairment
- Language impairment (i.e. severe dysarthria or aphasia)
- Not within age range listed
- Major or active psychiatric conditions
- Diagnosis of dementia
- Do not own a mobile device capable of downloading applications (i.e. Zoom), and/or do not have access to internet connection
Interventions
"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.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06582316