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

Study acronym: DiSaB
StatusUnknown
PhaseNot applicable
Started2025-04-02
View on ClinicalTrials.gov ↗
Record status
This record was last updated May 22, 2025 (before its estimated March 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-09-06
minor
Trial status changed: Recruiting → Unknown
2025-05-19
notable
Not Yet Recruiting→Unknown Study Identification, Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v1
Trial statusNot Yet Recruiting→Unknown
Primary completion date2025-05→2026-03
Completion date2025-12→2026-06
Start dateestimated 2024-09→confirmed 2025-04-02
Study sites0→1
Eligibility criteria+62 characters
[...] g 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 impairme [...]
Secondary endpointsdetails revised at 1 of 1 entry
Primary endpoints16 to 15 entries
Barriers and facilitators questionnaire (nurses) Change in psychosocialquality healthof life measured by EQ-5D-5L
Study titlerevised
Digital Solution for Salutogenic Brain Health (DiSaB): aA Pilot Protocol for Clinical Implementation
2024-08-30
minor
Original filing
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.
Trial Details
NCT Number NCT06582316
Lead Sponsor National University of Singapore
Conditions Chronic Condition
Enrollment 160 participants
Start Date 2025-04-02
Primary Completion 2026-03 (estimated)
Study Completion 2026-06 (estimated)
Updated on ClinicalTrials.gov 2025-05-22