Clinical trial NCT06496945: Assessing the Impact of DAy Programs on Individuals Living with Dementia and Their Family/friend Caregivers
Official title: Assessing the Impact of DAy Programs on Individuals Living with Dementia and Their Family/friend Caregivers (AIDA-DemCare)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Adult Day Programs
Continuing Care
Old Age; Dementia
Family/Friend Caregivers
Keywords: Adult day programs
Older adults
Program evaluation
Cohort studies
Health administrative data
Lead sponsor: York University
Sponsor class: OTHER
Collaborators: name: Carswell Family Foundation
name: Alzheimer Society of York Region
First posted: 2024-07-11
Enrollment: 3000
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study focuses on community care systems in the Calgary Health Zone (Alberta), Interior Health Region (British Columbia), Winnipeg Regional Health Authority (Manitoba), and York Region (Ontario). All of these regions assess day program eligibility using comparable processes, criteria, and assessments (i.e. RAI-HC). There are 89 publicly subsidized day programs in Alberta (\~3,300 spaces), 95 (\~1,500 spaces) in British Columbia, 70 (\~1,000 spaces) in Manitoba, and 300 (\~6,000 spaces) in Ontario. The numbers of individuals with dementia in the community are \~32,000 in Alberta, \~47,000 in British Columbia, \~11,000 in Manitoba, \~153,000 in Ontario.

The yearly average number of completed RAI-HC assessments is \~20,000-30,000 in Alberta, \~34,000-39,000 in British Columbia, and \~10,000 in Manitoba. The estimated number of day program attendees is \>20,000/year (\>200,000 within the study period), each with multiple assessments.

Brief summary: This study seeks to understand the effects of adult day programs on older adults, especially those with dementia, and their caregivers. A prospective cohort study will be conducted in the Canadian provinces of Alberta, British Columbia, Manitoba, and Ontario. Participants will be (1) older adults with dementia who attend a day program, and their caregivers, and (2) older adults with dementia in the community who do not attend a day program, and their caregivers. The objectives are to (1) evaluate the effects of day programs on attendee and caregiver outcomes, and (2) compare day program use patterns, attendee and caregiver social identities, day program characteristics, and day program outcomes between the 4 provinces, and (3) to explore what attendee and caregiver social identities and day program characteristics are associated with study outcomes, and with day program attendance/non-attendance.

Detailed description: Adult day programs provide critical supports to both, older adults with dementia in the community, and their family/friend caregivers. This is critical because ensuring high-quality care in the community for as long as possible, and avoiding or delaying facility-based continuing care are key priorities of individuals with dementia, their caregivers, and healthcare systems. While 61% of the 597,000 Canadians with dementia live in the community, about 10% of newly admitted nursing home residents have relatively low care needs that could be met in the community with the right supports. Caregivers to individuals with dementia (most of whom are women) provide more care hours per week (26 vs 17) than caregivers to older adults without dementia, are more likely to experience distress (45% vs 26%), and a caregiver's risk of distress is 1.6 times higher if the individual in need of care exhibits behavioural problems. However, research on the effectiveness of day programs is inconsistent. Generally, the methodological quality of studies is poor, and we especially lack Canadian research and research on individuals with multiple, intersecting vulnerabilities. Our research objectives are:

1. To evaluate the association of day program exposure with primary outcomes (better quality of life of attendees and caregivers), and secondary outcomes (better mental health of attendees and caregivers, increased time to admission to congregate care, slower cognitive and physical decline of attendees, lower rates of attendees' and caregivers' emergency room registrations, hospital admissions, and days in hospital)
2. To compare day program use patterns, attendee and caregiver social identities, day program characteristics, and day program outcomes between the 4 provinces
3. To explore what attendee and caregiver social identities, and day program characteristics are associated with primary and secondary outcomes, and with day program attendance/non-attendance

In this prospective, cross-provincial cohort study (York Region, Ontario; Interior Health, British Columbia; Calgary, Alberta; Winnipeg, Manitoba), a total of 1,000 day program attendees with dementia (250 per region), plus their primary caregivers will be recruited. A comparison group of 2,000 non-attendees with dementia and their caregivers will be created. Participants' longitudinal health administrative data will be combined with repeated (baseline and after 1 and 2 years) surveys to include critical variables not routinely collected by healthcare systems (e.g., quality of life, social identities). Primary study outcomes are quality of life of the person with dementia and their caregiver. Secondary study outcomes include mental health of individuals with dementia and caregivers, cognitive and physical decline of individuals with dementia, time to admission to congregate care, and system-level rates of emergency room registrations, hospital admissions, and days in hospital (including alternative level of care) of individuals with dementia and caregivers. Using a day program survey, we will also assess day program characteristics (e.g., number of spaces, staffing, programming). Using general estimating equations and time-to-event models, these outcomes will be compared between groups of day program exposure (no, low, medium, high). Models will be adjusted for community-based services (e.g., home care, respite care), day program characteristics, social identities of older adults and caregivers, time since day program admission, and other older adult and caregiver characteristics.

Eligibility criteria: Inclusion Criteria:

* Older adults (65+ years) with a diagnosis of dementia, who live in the community, and either attend an adult day program (cohort 1), or receive continuing care in the community with an initial RAI-HC assessment completed (cohort 2)
* Primary caregiver (i.e., most involved with and informed about the care) of an eligible older adult

Exclusion Criteria:

* Older adults with or without dementia who do not receive any community-based continuing care service
* Day program attendees or community care recipients who do not have a diagnosis of dementia or who are younger than 65 years
* Secondary caregivers

Primary outcomes:
measure: Older adult quality of life (self-report)
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
measure: Older adult quality of life (proxy-report)
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
measure: Caregiver quality of life
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
Secondary outcomes:
measure: Older adult mental health
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
measure: Caregiver distress
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
measure: Caregiver symptoms of depression
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
measure: Caregiver symptoms of anxiety
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
measure: Presence or absence of physical decline among older adults
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
measure: Presence or absence of cognitive decline among older adults
timeFrame: Baseline (Jan-Mar 2025), and after 1 and 2 years
measure: Older adult time to admission to a continuing care home
timeFrame: From date of home care admission until the date of admission to a continuing care home or loss to follow up (i.e., death, move out of province), whichever came first, assessed up to 2.5 years (between baseline and 2-year follow up)
measure: Older adult emergency room registrations
timeFrame: 1 and 2 years after the baseline data collection (which is estimated to be carried out Jan-Mar 2025)
measure: Caregiver emergency room registrations
timeFrame: 1 and 2 years after the baseline data collection (which is estimated to be carried out Jan-Mar 2025)
measure: Older adult hospital stays
timeFrame: 1 and 2 years after the baseline data collection (which is estimated to be carried out Jan-Mar 2025)
measure: Caregiver hospital stays
timeFrame: 1 and 2 years after the baseline data collection (which is estimated to be carried out Jan-Mar 2025)
measure: Older adult primary care provider visits
timeFrame: 1 and 2 years after the baseline data collection (which is estimated to be carried out Jan-Mar 2025)
measure: Caregiver primary care provider visits
timeFrame: 1 and 2 years after the baseline data collection (which is estimated to be carried out Jan-Mar 2025)
Other outcomes:
Locations:
city: Edmonton & Calgary
country: Canada
facility: Edmonton and Calgary Health Zones
state: Alberta
city: Multiple
country: Canada
facility: Interior Health Region
state: British Columbia
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Authority
state: Manitoba
city: Multiple
country: Canada
facility: York Region
state: Ontario
Study officials:
affiliation: York University
name: Matthias Hoben, Dr rer medic
role: PRINCIPAL_INVESTIGATOR
References: