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

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Condition
• Intervention / Treatment: Other: Brain Health Training Programme

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: YanHong Dong, PhD; Phone Number: 65-65168686; Email: nurdy@nus.edu.sg

Study Locations

• Singapore
  • Singapore, Singapore
    • Recruiting
    • National University Polyclinics
    • Contact: Wei Fong Liau; Phone Number: (65) 67163498; Email: wei_fong_liau@nuhs.edu.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Arm; Participants will undergo 8 sessions of digital "Train Your Brain" programme lead by a trained clinical neuropsychologist over 2 months.	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.
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction feedback questionnaire (patients)	Completed online	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
Change in heart rate	Heart rate will be measured on-site	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)
Change in lipid levels	Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps	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)
Change in HbA1c levels	Information will be obtained from patients; HealthHub/Health Buddy/OneNUHS or other health apps	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)
Change in blood pressure	Blood pressure will be measured on-site	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)
Change in SDMT scores	Symbol Digit Modality Test (SDMT). Total maximum score is 110. Higher scores indicate better cognitive performance.	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)
Change in psychosocial health measured by DaSS-21	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.	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)
Change in MoCA scores	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.	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)
Change in quality of life measured by EQ-5D-5L	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.	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)
Change in psychosocial health measured by AD8	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.	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)
Change in psychosocial health measured by Self-care of chronic illness inventory	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.	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)
Feedback from patients using focus group interview	Questions are developed from RE-AIM model. Participants will be randomly chosen (n=30) to take part in the focus group interview.	Final follow up (month 9/12)
Effectiveness of TYB intervention questionnaire (nurses)	Using RE-AIM model; completed online. Questionnaire will be given at multiple time points throughout the study, as listed below.	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)
Effectiveness of DiSaB intervention questionnaire (patients)	Using RE-AIM model; completed online. Questionnaire is given at multiple points throughout the study, as listed below.	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)
Feedback from nurses using focus group interview	Questions are developed from RE-AIM model	Month 6 (immediately after completion of 2-month-long TYB intervention control arm)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Economic evaluation on the feasibility of DiSaB implementation using cost-effectiveness questionnaire	For evaluation of economics and further impact	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)

Collaborators and Investigators

• Sponsor: National University of Singapore

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2025
• Primary Completion (Estimated): March 1, 2026
• Study Completion (Estimated): June 1, 2026

Study Registration Dates

• First Submitted: August 16, 2024
• First Submitted That Met QC Criteria: August 30, 2024
• First Posted (Actual): September 3, 2024

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 19, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Hypertension; Cognition; Implementation Science; Digital Intervention; Type-2 Diabetes; Hyperlipidaemia
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Chronic Disease
• Other Study ID Numbers: 2023/00620

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No