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

NCT06582316 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2025-05-22

No results posted yet for this study

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.

Conditions

  • Chronic Condition

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
40 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-02
Primary Completion
2026-03-31
Completion
2026-06-30

Countries

  • Singapore

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06582316 on ClinicalTrials.gov