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

National University of Singapore

Status: Enrolling

Conditions: Chronic Condition

Treatments: Other: Brain Health Training Programme

Study type: Interventional

Funder types: Other

Identifiers

NCT06582316

2023/00620

Details and patient eligibility

About

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.

Full 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.

Enrollment: 160 estimated patients

Sex: All

Ages: 40 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Intervention Arm

Experimental group

Description:

Participants will undergo 8 sessions of digital "Train Your Brain" programme lead by a trained clinical neuropsychologist over 2 months.

Treatment:

Other: Brain Health Training Programme

Control Arm

No Intervention group

Description:

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.