Increasing numbers of older adults are living with dementia, particularly in low- and middle-income countries. Most prevention efforts emphasize control of medical risk factors such as hypertension, diabetes and sensory loss, while recent pharmacological approaches have shown limited efficacy and high cost. The protocol describes a different approach: targeting social isolation, a known risk factor for dementia, through an authentic participatory research model intended to increase social engagement and thereby support cognitive processes, especially executive function.
The investigators identify three core features of authentic participatory research—shared governance, use of evidence and innovation—and note their conceptual alignment with components of executive functioning. The pilot study aims to test feasibility and acceptability of this participatory dementia prevention approach in two very different contexts: urban Montreal, Canada, and two rural communities in Botswana.
This is a pilot randomised controlled trial conducted in two settings: urban Montreal and two rural communities in Botswana. The trial uses a delayed-intervention (wait-list) control design, with community-level allocation in Botswana and individual-level allocation in Montreal. The protocol specifies intervention delivery in the immediate arm and provision of the same intervention to the delayed arm after an 18-month waiting period.
Eligible participants are women and men aged 65 years and older who meet the study definition of social isolation: not in paid or voluntary employment and not married. The investigators aim to recruit at least 100 participants in Botswana and at least 100 participants in Montreal. In Montreal, the recruitment includes clinic-related participants for whom ethics approval was obtained for recruitment procedures.
The intervention comprises six structured steps intended to engage participants collaboratively around priorities and solutions:
The approach emphasizes shared governance and local innovation, mobilizing participant-identified priorities to foster social engagement and action. Details about exact group sizes, facilitation methods, or manuals were not reported in the source summary.
The protocol specifies cognitive and questionnaire-based outcome measures collected at baseline, 18 months and 33 months. Executive function will be measured using the Frontal Assessment Battery (FAB). Additional assessments include a questionnaire that measures integral brain health, physical health and degree of social isolation. The study will also collect qualitative material in the form of narratives of change to capture participants' experiences of the intervention.
The study aims to recruit at least 100 participants in each country setting (Botswana and Montreal). In Botswana, randomisation is at the community level: one community is randomly allocated to receive the intervention immediately and the other community to serve as delayed control (receiving the intervention after 18 months). In Montreal, individual participants are randomly allocated to immediate or delayed intervention groups; randomisation occurs before participants are grouped by their shared concern.
No additional power calculations or effect size estimates were reported in the source summary.
Quantitative analysis will include comparison of outcome measures across time points (baseline, 18 months, 33 months) to evaluate feasibility and potential cognitive and health-related changes. The Frontal Assessment Battery scores will be central for assessing executive function. The investigators will also analyse narratives of change at the end of intervention periods to understand participant experience, acceptability and perceived impacts. Specific statistical methods, handling of missing data and predefined primary versus secondary endpoints were not detailed in the provided summary.
Ethical approvals reported in the source include:
Planned dissemination includes community meetings in the Botswana pilot communities, briefings with government and non-government stakeholders convened by the Botswana Ministry of Health and the Social Development Department of the Ministry of Local Government and Traditional Affairs, research meetings and other fora in Montreal, oral and poster presentations at local, national and international conferences, and publication in peer-reviewed indexed journals.
The trial is registered with ISRCTN under the number ISRCTN14273485.