Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06582316

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Chronic Condition Cardiovascular Diseases Chronic Disease Disease Attributes Dyslipidemias Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Vascular Diseases

Age range

40 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The effectiveness of the DiSaB intervention implementation at primary care setting amongst participants with long term conditions will be evaluated using the Reach, Effectiveness, Adoption, Implementation and Maintenance (RE-AIM) model.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Brain Health Training Programme

Other

"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.

Primary outcomes

  1. Change in heart rate

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)

    Heart rate will be measured on-site

  2. Change in lipid levels

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)

    Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps

  3. Change in HbA1c levels

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)

    Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps

  4. Change in blood pressure

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)

    Blood pressure will be measured on-site

  5. Change in SDMT scores

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)

    Symbol Digit Modality Test (SDMT). Total maximum score is 110. Higher scores indicate better cognitive performance.

  6. Change in psychosocial health measured by DaSS-21

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)

    Depression, Anxiety and Stress Scale -21 item (DASS-21) Physical or online. There are 21 questions that are scored from 0 to 3, and the highest possible score is 63. Higher scores indicate poorer psychological health.

  7. Change in MoCA scores

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)

    Montreal Cognitive Assessment (MoCA). Total possible score is 30 (scoring is on the MoCA form itself), and a score of at least 26 indicates normal cognition. Higher scores indicate better cognition.

  8. Change in quality of life measured by EQ-5D-5L

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)

    EuroQol 5 Dimension 5 Level (EQ-5D-5L) Physical or online. Each question is scored from 1 to 5, with 1 indicating no problems in that dimension and 5 indicating total inability to perform in that dimension.

  9. Change in psychosocial health measured by AD8

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)

    Alzheimer's Disease-8 Component (AD8) Physical or online. There are a total of 8 questions asking about thinking ability, and each answer is coded 1 (yes, change present) or 0 (no change). 0 or 1 indicates normal cognition, and a score of at least 2 suggests that cognition issues might be present.

  10. Change in psychosocial health measured by Self-care of chronic illness inventory

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; month 9/12)

    Physical or online. 29 questions in total, answers are scored from 1 to 5. Higher scores indicate better self-care. When referencing standard scores, a standard score of 70 is the cut-off point for self-care adequacy.

  11. Patient satisfaction feedback questionnaire (patients)

    Time frame: Weekly (right after each TYB intervention) for 2 months. Also after health education sessions: either once [individual session] OR monthly for 3 months [group session]; during months 4-6) - intervention arm non-responders only

    Completed online

  12. Feedback from patients using focus group interview

    Time frame: Final follow up (month 9/12)

    Questions are developed from RE-AIM model. Participants will be randomly chosen (n=30) to take part in the focus group interview.

  13. Effectiveness of TYB intervention questionnaire (nurses)

    Time frame: Weekly for 2 months (after each TYB intervention - months 1-3 for intervention arm and months 4-6 for control arm), final follow up (month 12)

    Using RE-AIM model; completed online. Questionnaire will be given at multiple time points throughout the study, as listed below.

  14. Effectiveness of DiSaB intervention questionnaire (patients)

    Time frame: Once at the end of TYB intervention (month 3 for intervention arm, month 6 for control arm), once during final follow-up (month 9/12 for all participants)

    Using RE-AIM model; completed online. Questionnaire is given at multiple points throughout the study, as listed below.

  15. Feedback from nurses using focus group interview

    Time frame: Month 6 (immediately after completion of 2-month-long TYB intervention control arm)

    Questions are developed from RE-AIM model

Secondary outcomes

  1. Economic evaluation on the feasibility of DiSaB implementation using cost-effectiveness questionnaire

    Time frame: Baseline (all participants; month 0), first follow up (all participants; month 3), second follow up (only for control group; at month 6), and final follow up (all participants; months 9/12)

    For evaluation of economics and further impact

Study contacts

Contact information is provided by the study sponsor or research team.

YanHong Dong, PhD

CONTACT

[email protected]

65-65168686

Sponsors and collaborators

Lead sponsor

National University of Singapore

Other

Registry information

Official study title

Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Sequential Multiple Assignment Randomised Trial (SMART) Protocol for Clinical Implementation

Acronym: DiSaB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 3, 2024
Registry last updated
May 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.