Digital intervention for improving brain health in middle-aged adults
Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Sequential Multiple Assignment Randomised Trial (SMART) Protocol for Clinical Implementation
This study is testing a digital program to see if it can help middle-aged adults with chronic conditions improve their brain health and overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 160 (estimated) |
| Ages | 40 Years to 64 Years |
| Sex | All |
| Sponsor | National University of Singapore Academic / other |
| Locations | 1 site (Singapore) |
| Trial ID | NCT06582316 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a digitally delivered brain health intervention called DiSaB, designed to enhance cognitive, physical, and psychosocial health in middle-aged adults with chronic conditions at risk for cognitive decline. The study will compare the effectiveness of the DiSaB intervention against a control group receiving no intervention, utilizing the RE-AIM model to assess its implementation in primary care settings. Additionally, it will explore the barriers and facilitators to implementing the intervention among healthcare professionals using the COM-B model. The trial will also employ a sequential multiple assignment randomized trial (SMART) design to tailor treatment regimens based on individual responses.
Who should consider this trial
Good fit: Ideal candidates are middle-aged adults aged 40-55 with hypertension, hyperlipidaemia, and/or type-2 diabetes who are at risk for cognitive decline.
Not a fit: Patients with major psychiatric conditions, dementia, or severe impairments that prevent participation may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve cognitive and overall health outcomes for middle-aged adults with chronic conditions.
How similar studies have performed: Other studies have shown promise in using digital interventions for health improvement, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Singapore
- National University Polyclinics — Singapore, Singapore (Recruiting)
Study contacts
- Study coordinator: YanHong Dong, PhD
- Email: nurdy@nus.edu.sg
- Phone: 65-65168686
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.