EXploring Patterns of Use and Effects of Adult Day Programs to Improve Trajectories of Continuing CarE (EXPEDITE)

January 21, 2025 updated by: Matthias Hoben, York University

EXploring Patterns of Use and Effects of Adult Day Programs to Improve Trajectories of Continuing CarE (EXPEDITE)

This study seeks to understand the impact of Canada's adult day program on attendees and non-attendees, especially those with dementia and other co-morbidities. A retrospective cohort study will be conducted, including older adults in the community who do or do not attend adult day programs in Alberta, British Columbia, and Manitoba, Canada. The objectives are to (1) compare patterns of day program use (including non-use) by Canadian province (Alberta, British Columbia, Manitoba), and time, (2) compare characteristics of older adults by day program use pattern (including non-use), province, and time, and (3) to examine whether those who are exposed to day programs, compared to a propensity-score matched comparison group of non-exposed older adults in the community, enter long-term care homes at later times (primary outcome), are less likely to have depressive symptoms, physical and cognitive change, and have lower use of primary, acute, and emergency care (secondary outcomes).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Adult day programs provide critical supports to both, older adults living in the community, and their family/friend caregivers. This is essential because ensuring high-quality care in the community for as long as possible and avoiding or delaying long-term care home admissions are key priorities of older adults, their caregivers, and healthcare systems. While most older adults in Canada receive care 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 provide most of the care in the community, which puts them at high risk for caregiver burden. Day programs intend to mitigate these issues by providing respite to caregivers. However, research on the effectiveness of day programs is inconsistent. Generally, the methodological quality of studies is poor, and especially Canadian research is lacking. The research objectives are to (1) explore changes in patterns of day program use (including non-use) between provinces and over time, (2) compare characteristics of older adults with different day program use patterns (including non-use), and (3) assess whether day program attendees compared to a propensity score matched control group of non-attendees have better outcomes. This retrospective cohort study will use population-based clinical and health administrative data of older adults (65+ years) who received publicly subsidized continuing care in the community in Alberta, British Columbia, and Manitoba between January 01, 2012 and December 31, 2024. Patterns of day program use (i.e., variations in time to attend a day program for the first time, and frequency and duration of attendance) and how these patterns vary by province and over time will be assessed. Characteristics of older adults with different patterns of day program use (e.g., no, low, medium, high) will be compared. Characteristics of the participants will include age, sex, dementia status, frailty level, comorbidity status, socioeconomic status, availability of a caregiver, and caregiver distress. Finally, propensity-matched comparison group (by region, age, gender, cognitive/physical impairment, type/duration of community care received previously) of older adults who have not attended a day program will be created. Time-to-event models and general estimating equations will assess whether day program attendees compared to non-attendees enter continuing care facilities later (primary outcome); use emergency, acute, or primary care less frequently; experience less cognitive and physical decline; and have better mental health (secondary outcomes). Models will include day program exposure as an independent variable and will be adjusted for province, participant demographics, medical and functional conditions, caregiver availability/distress, other community services received (e.g., home care, in-home respite), and (if appropriate) matching variables.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Matthias Hoben, Dr rer medic
  • Phone Number: +1 437-335-1338
  • Email: mhoben@yorku.ca

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study focuses on community care systems in Alberta, British Columbia, and Manitoba, all of which assess day program eligibility using comparable processes, criteria, and assessments (i.e. RAI-HC). 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.

Description

Inclusion criteria:

  • Persons aged 65 years and over
  • Initial RAI-HC assessment completed
  • Attendance of an adult day program (for cohort 1)
  • Receipt of any community-based continuing care services, other than adult day program (cohort 2)

Exclusion criteria:

- No receipt of any community-based continuing care service

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Day program attendees
Older adults (65+ years) attending an adult day program in Alberta, British Columbia, or Manitoba
Other: Adult day program use
Day program use patterns will be determined, using Latent Class Analysis. Three continuous variables will be categorized as low, low-moderate, high-moderate, high, using sample distribution quartiles: (1) Time between first RAI-HC assessment and first attendance of a day program, (2) average number of hours of day program attendance (i.e., total number of hours spent in a day program divided by the number of times attended), and (3) total number of days a person attended a day program.
Non-attendees
Older adults with an initial Resident Assessment Instrument - Home Care (RAI-HC), who are not attending a day program in Alberta, British Columbia, or Manitoba
Other: Other community care (non-attendees)
Any publicly funded continuing care services in the community, other than adult day programming (e.g., home care, in-home respite). Community care participants will be propensity score matched with day program participants, using RAI-HC variables on day program eligibility (to ensure similarity of non-attendees to day program attendees). Matching variables will include: physical functioning, cognition, behavioural symptoms, bladder/bowel continence, availability of a caregiver, and caregiver distress. The investigators will also include variables on health and social characteristics (e.g., age, sex, type/duration of publicly funded community care received before the matching index date, deprivation indices).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to admission to a long-term care homes
Time Frame: From date of home care admission until the date of admission to a long-term care home or loss to follow up (i.e., death, move out of province), whichever came first, assessed up to 12 years (between Jan 31, 2012 and Dec 31, 2024)
Data will come from provincial continuing care registries, which document the start date of any publicly funded continuing care service a person receives, the end date of this service, and the type of service. The outcome will be the time between a person's first RAI-HC assessment and admission to a long-term care home (i.e., an assisted living home or nursing home).
From date of home care admission until the date of admission to a long-term care home or loss to follow up (i.e., death, move out of province), whichever came first, assessed up to 12 years (between Jan 31, 2012 and Dec 31, 2024)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Symptoms of depression
Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
To determine the presence or absence of depressive symptoms, the validated RAI-HC Depression Rating Scale (DRS) will be used. DRS scores range from 0-14, and a cut-point of 3 or higher represents clinically meaningful depressive symptoms.
Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
Presence or absence of physical decline
Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
Change in physical functioning will be captured, using the validated RAI-HC Activities of Daily Living Hierarchy (ADLh) scale. The scale ranges from 0 (no impairment) to 6 (maximum impairment), and the outcome will be dichotomous, indicating any increase (versus no change or a decrease) between the previous and follow up measurement in this scale.
Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
Presence or absence of cognitive decline
Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
Change in cognition will be captured, using the validated RAI-HC Cognitive Performance Scale (CPS). The scale ranges from 0 (no impairment) to 6 (maximum impairment), and the outcome will be dichotomous, indicating any increase (versus no change or a decrease) between the previous and follow up measurement in this scale.
Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
Emergency room registrations
Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
The National Ambulatory Care Report System (NACRS) captures all emergency department visits and diagnoses. The outcome will be the yearly average number of a person's emergency department visits.
Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
Hospital stays
Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
The Discharge Abstract Database (DAD) includes information on all inpatient hospital stays, including diagnoses and length of stay. The outcome will be the yearly average number of a person's hospital stays.
Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
Primary care provider visits
Time Frame: Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first
Care provider claims data includes health service claims submitted for payment by primary care providers (e.g., general practitioners, nurse practitioners, geriatricians, geriatric psychiatrists, neurologists, therapists). The outcome will be the yearly average number of a person's primary care provider visits.
Baseline (date of home care admission) and annually until study end (Dec 31, 2024) or loss to follow up, whichever came first

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
York University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Carswell Family Foundation
Alzheimer Society of York Region

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Matthias Hoben, PhD, York University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 563198b

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The health administrative data used in this study are owned by the respective provincial health authorities. Provincial data policies do not allow public sharing of these data. The research team will work with an in-house health system data analyst in each of the provinces to carry out the analyses. Data are required to stay within the respective province and within the province's protected and secure data repository.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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