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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-64
SponsorNational University of Singapore

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Physical, visual and/or hearing impairment

Language impairment (i.e. severe dysarthria or aphasia)

Not within age range listed

Major or active psychiatric conditions

Trial design

Design model

Sequential

Treatments tested in this trial

  • Brain Health Training Programme

    Other intervention

    "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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Intervention ArmExperimental treatment 1 intervention
Group B: Control ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Change in heart rate

Heart rate will be measured on-site

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)
2

Change in lipid levels

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

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)
3

Change in HbA1c levels

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

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)
4

Change in blood pressure

Blood pressure will be measured on-site

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)

Secondary outcomes

1

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

For evaluation of economics and further impact

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)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.