Authentic participatory research with older adults for cognitive health

ISRCTN ISRCTN14273485
DOI https://doi.org/10.1186/ISRCTN14273485
Submission date
24/01/2025
Registration date
10/02/2025
Last edited
10/02/2025
Recruitment status
Recruiting
Overall study status
Ongoing
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Most people with dementia live in low- and middle-income countries, where there are fewer care resources. This study aims to prevent cognitive loss and improve care for older adults in Montreal and a rural area in Botswana. It focuses on increasing social engagement to help prevent dementia.

Who can participate?
Older women and men who are associated with a well-known long-term care organization in Montreal or who live in rural communities in south-eastern Botswana.

What does the study involve?
Participants will identify challenges in their living conditions and work together to find solutions. They will use visual and arts-based methods to express their needs. The study will compare these participants with others who receive usual care, measuring cognitive health and wellbeing.

What are the possible benefits and risks of participating?
Benefits may include improved cognitive health, better social engagement, and enhanced wellbeing. There are no significant risks mentioned, but as with any study, there may be unforeseen challenges.

Where is the study run from?
The study is run from Montreal, Canada, and rural communities in south-eastern Botswana.

When is the study starting and how long is it expected to run for?
The study starts in April 2024 and is expected to run until March 2028.

Who is funding the study?
The study is funded by the Canadian Institutes for Health Research.

Who is the main contact?
The main contact for the study is Professor Neil Andersson, who can be reached at neil.andersson@mcgill.ca.

Study website

Contact information

Prof Neil Andersson
Public, Scientific, Principal Investigator

Family Medicine, 5858 Cote des Neige
Montreal
H3Z 1Z1
Canada

ORCiD logoORCID ID 0000-0003-1121-6918
Phone +1 8196640040
Email neil.andersson@mcgill.ca

Study information

Study designMulticenter intervention open-label cluster randomized controlled trial
Primary study designInterventional
Secondary study designCluster randomised trial
Study setting(s)Community
Study typePrevention
Participant information sheet Not available in web format, please use contact details to request a participant information sheet
Scientific titleImplications of participation mechanisms on executive function and dementia prevention
Study acronymAPROACH
Study objectivesCo-management of shared concerns, active use of evidence and innovation, corresponding with hypothesized executive functions, revitalizes cognitive capacity and prevents Alzheimer's Disease
Ethics approval(s)

Approved 18/09/2024, Institutional Review Board McGill Faculty of Medicine and Health Sciences (3655 Sir William Osler #633, Montreal, H3G 1Y6, Canada; +1 (514) 398-3124; researchethics@mcgill.ca), ref: A066-M27-24A (24-06-020)

Health condition(s) or problem(s) studiedAlzheimer's Disease
InterventionControl (delayed intervention) Arm:
- Clinical exam (blood pressure, diabetes, sight, hearing)
- Cognitive test (Frontal Assessment Battery)
- Baseline questionnaire including individual priority issue and personal goal
- After 18 months, the intervention will begin in the control arm, and the baseline implemented in a new control (delayed intervention) arm

Intervention arm
- Clinical exam (blood pressure, diabetes, sight, hearing)
- Cognitive test (Frontal Assessment Battery)
- Baseline questionnaire including individual priority issue and personal goal
- Intervention protocol
• Group Assignments: 3-8 members sharing priority
• Collaborative Analysis in groups
• Participant-led actions/innovations
• Group socializing results (using visual and arts-based media)
• Self-evaluation - participants to rate their progress against their personal goals through interview after conclusion of the cycle or sharing of results, the 12th session or before (we expect 6 months per cycle)

Randomisation:
-Cluster randomisation using online random number generator.
Intervention typeBehavioural
Primary outcome measureExecutive function as measured by Frontal Assessment Battery and MOCA at baseline, 12 months, 24 months
Secondary outcome measures1. Self-assessed Integral brain health measured using the Integral Brain Health questionnaire at baseline and each year
2. Behavioural outcomes at baseline and annual follow up:
2.1. Berkman-Syme isolation index
2.2. Health self-assessment
2.3. Physical activity self-assessment
2.4. Autonomy self-assessment related to finances and medication administration
2.5. Health services use
3. Cognitive assessment: Participant changes in overall cognitive functioning will be measured using the MoCA64; we will use the five items of MOCA to validate the Frontal Assessment Battery (FAB) at baseline and each year
Overall study start date01/04/2024
Completion date30/03/2028

Eligibility

Participant type(s)Resident
Age groupSenior
Lower age limit65 Years
Upper age limit100 Years
SexBoth
Target number of participants100 clusters with 20-40 participants in each
Key inclusion criteria1. Older than 65 years
2. Completed FAB-MOCA baseline (non-dementia)
3. Health exam addressing eyesight, hearing, blood pressure and diabetes management
4. Complete baseline questionnaire
Key exclusion criteriaCognitive disability including dementia
Date of first enrolment01/03/2025
Date of final enrolment01/03/2028

Locations

Countries of recruitment

  • Botswana
  • Canada

Study participating centres

CIET Trust
POBox 1240
Gaborone
-
Botswana
Centre for Research in Aging
Lady Davis Institute for Medical Research - Jewish General Hospital
3755 Cote Ste-Catherine, H-461
Montreal
H3T 1E2
Canada

Sponsor information

Canadian Institutes for Health Research
Research council

160 Elgin Street, 9th Floor
Ottawa
K1A 0W9
Canada

Phone +1 613-941-2672
Email support-soutien@cihr-irsc.gc.ca
Website https://cihr-irsc.gc.ca/

Funders

Funder type

Government

Canadian Institutes for Health Research

No information available

Results and Publications

Intention to publish date01/03/2029
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryAvailable on request
Publication and dissemination planPlanned publication in peer-reviewed journals
IPD sharing planData sharing will be determined by the conditions agreed in the informed consent. No individual or community identities will be shared.

Editorial Notes

27/01/2025: Trial's existence confirmed by McGill University