Clinical trial NCT06582316: Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Protocol for Clinical Implementation
Official title: Digital Solution for Salutogenic Brain Health (DiSaB): A Pilot Sequential Multiple Assignment Randomised Trial (SMART) Protocol for Clinical Implementation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Condition
Keywords: Cognition
Implementation Science
Digital Intervention
Hypertension
Hyperlipidaemia
Type-2 Diabetes
Lead sponsor: National University of Singapore
Sponsor class: OTHER
First posted: 2024-09-03
Enrollment: 160
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: HEALTH_SERVICES_RESEARCH

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. 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in heart rate
timeFrame: 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)
measure: Change in lipid levels
timeFrame: 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)
measure: Change in HbA1c levels
timeFrame: 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)
measure: Change in blood pressure
timeFrame: 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)
measure: Change in SDMT scores
timeFrame: 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)
measure: Change in psychosocial health measured by DaSS-21
timeFrame: 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)
measure: Change in MoCA scores
timeFrame: 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)
measure: Change in quality of life measured by EQ-5D-5L
timeFrame: 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)
measure: Change in psychosocial health measured by AD8
timeFrame: 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)
measure: Change in psychosocial health measured by Self-care of chronic illness inventory
timeFrame: 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)
measure: Patient satisfaction feedback questionnaire (patients)
timeFrame: 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
measure: Feedback from patients using focus group interview
timeFrame: Final follow up (month 9/12)
measure: Effectiveness of TYB intervention questionnaire (nurses)
timeFrame: 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)
measure: Effectiveness of DiSaB intervention questionnaire (patients)
timeFrame: 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)
measure: Feedback from nurses using focus group interview
timeFrame: Month 6 (immediately after completion of 2-month-long TYB intervention control arm)
Secondary outcomes:
measure: Economic evaluation on the feasibility of DiSaB implementation using cost-effectiveness questionnaire
timeFrame: 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:
Locations:
city: Singapore
country: Singapore
facility: National University Polyclinics
Study officials:
References: