Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Protocol for Clinical Implementation
NCT ID: NCT06582316
Last Updated: 2025-05-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
160 participants
INTERVENTIONAL
2025-04-02
2026-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
My Healthy Brain: Preserving and Promoting Brain Health Through Evidence-based Practices
NCT04537728
Improving Well-Being for Older Adult Family Dementia Caregivers
NCT03881631
Mindfulness to Improve Elders' Immune and Health Status
NCT01027780
Cerebrovascular Health and Resilience in Midlife
NCT06029348
Promoting Mental and Cognitive Health in Old Age Through Scalable Evidence-based Interventions
NCT07072338
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SEQUENTIAL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention Arm
Participants will undergo 8 sessions of digital "Train Your Brain" programme lead by a trained clinical neuropsychologist over 2 months.
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.
Control Arm
Participants will not undergo any sessions of digital "Train Your Brain" programme for 2 months when intervention arm's brain health training programme is ongoing.
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
40 Years
64 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National University of Singapore
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Catherine Yanhong Dong, PhD
Assistant Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
National University Polyclinics
Singapore, , Singapore
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
Chang CSY, Phua V, Tham XC, Jia Y, Chen NYC, Zhou W, Liau WF, Xu J, Chakraborty B, Graves N, Sevdalis N, Dong Y. Digital solution for salutogenic brain health: a pilot sequential multiple assignment randomised trial (SMART) protocol for clinical implementation. BMJ Open. 2025 Mar 25;15(3):e096568. doi: 10.1136/bmjopen-2024-096568.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023/00620
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.