Authentic participatory research with older adults for cognitive health
| ISRCTN | ISRCTN14273485 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14273485 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | Canadian Institutes for Health Research |
| Funder | Canadian Institutes for Health Research |
- 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
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.
Contact information
Public, Scientific, Principal investigator
Family Medicine, 5858 Cote des Neige
Montreal
H3Z 1Z1
Canada
 ORCID ID |
0000-0003-1121-6918 |
|---|---|
| Phone | +1 8196640040 |
| neil.andersson@mcgill.ca |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicenter intervention open-label cluster randomized controlled trial |
| Secondary study design | Cluster randomised trial |
| Study type | Participant information sheet |
| Scientific title | Implications of participation mechanisms on executive function and dementia prevention |
| Study acronym | APROACH |
| Study objectives | Co-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) studied | Alzheimer's Disease |
| Intervention | Control (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 type | Behavioural |
| Primary outcome measure(s) |
Executive function as measured by Frontal Assessment Battery and MOCA at baseline, 12 months, 24 months |
| Key secondary outcome measure(s) |
1. Self-assessed Integral brain health measured using the Integral Brain Health questionnaire at baseline and each year |
| Completion date | 30/03/2028 |
Eligibility
| Participant type(s) | Resident |
|---|---|
| Age group | Senior |
| Lower age limit | 65 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 2000 |
| Key inclusion criteria | 1. 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 criteria | Cognitive disability including dementia |
| Date of first enrolment | 01/03/2025 |
| Date of final enrolment | 01/03/2028 |
Locations
Countries of recruitment
- Botswana
- Canada
Study participating centres
Gaborone
-
Botswana
3755 Cote Ste-Catherine, H-461
Montreal
H3T 1E2
Canada
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | Data sharing will be determined by the conditions agreed in the informed consent. No individual or community identities will be shared. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/01/2025: Trial's existence confirmed by McGill University
