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

NCT06582316 | Recruiting

• 1 other identifier: 2023/00620
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the DiSaB intervention improve participants' cognitive functions, health measures, and psychosocial health?
2. 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. 3.How useful and practical is the DiSaB intervention, according to
4. 4.participants and
5. 5.nurses carrying out the intervention?
6. 6.Complete cognitive assessments, questionnaires, and health tests before intervention, immediately after the intervention, and 6 months after the intervention
7. 7.Either undergo no intervention, or undergo the DiSaB intervention over 2 months
8. 8.Be randomly selected to attend focus group interviews

Conditions

Chronic Condition

Keywords

Cognition; Implementation Science; Digital Intervention; Hypertension; Hyperlipidaemia; Type-2 Diabetes

Outcome Measures

Primary Outcomes (15)

• 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)

• 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

• 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 Outcomes (1)

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

  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)

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Control Arm

NO INTERVENTION

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.

Interventions

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.

Intervention Arm

Eligibility Criteria

• Age: 40 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National University of Singapore: lead

Study Sites (1)

National University Polyclinics

Singapore, Singapore

RECRUITING

Related Publications (1)

• 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.

  PMID: 40132849 DERIVED

MeSH Terms

Conditions

Chronic Disease; Hypertension; Hyperlipidemias

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

YanHong Dong, PhD

CONTACT

65-65168686; nurdy@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 16, 2024
• First Posted: September 3, 2024
• Study Start: April 2, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 22, 2025

Record last verified: 2024-08

Locations

SG (1)