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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05368480
Other study ID # 22-04-7161
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date May 2, 2022
Est. completion date December 1, 2025

Study information

Verified date May 2022
Source University of Notre Dame
Contact William N Evans, PhD
Phone 574-631-7039
Email wevans1@nd.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Senior Companion Programs (SCP) facilitate partnerships between community volunteers and local homebound seniors. Seniors served by the SCP will be provided with a companion who will conduct weekly visits with them, help with meal preparation or deliveries, provide transportation, assist with simple housekeeping, and socialize with the client amongst other tasks. These services are directed towards helping the senior client continue living independently in their own home instead of moving into an assisted living or nursing home. The SCP model is being evaluated to determine the impact of the services on the client's overall well-being and independent living status.


Description:

When a client calls an agency or referring agency to ask for a senior companion, the client will be screened for the above-mentioned eligibility criteria. Typically, most SCPs have wait lists for services. If the client calls when no companions are available the client will be told that the client is on a waitlist for services. When a companion becomes available, the agency will call the top two clients on the waitlist that match the new companion's available location (since most of the agencies involved serve large regions, matching on geography is important). With each of these clients, the agency worker will meet in person to conduct an intake interview. During the interview, the clients will be provided with information about the study and asked to consent. It is up to the agency to determine if the client is capable of directing their own care. If the client is not capable, and the client has a Power of Attorney (POA), the POA must be present and provide consent on behalf of the new client. If the client is not capable, and the client does not have a POA, the client will not be consented into the study. All clients, regardless of consent status will complete the intake interview with the agency caseworker. This information will act as a baseline survey. In rare cases, seeing a client's home in person might make them ineligible (if it appears unsafe for a companion to visit them), in which case the agency will interview the next person on the waitlist. Once two clients are eligible and have completed intake interviews, the agency will use a separate survey application, which on the backend will randomly assign one client to treatment and one to control. The agency will call each client and let them know either that they will receive a companion or that they do not have the capacity to provide them with a companion. The above procedure will be in effect when there is an active wait list for services. If a senior calls to request services when a companion is available and there are no other requests for services, the client will immediately be given the companion and will not be a part of the study. All clients will be surveyed 6- and 18-months post-randomization and will be tracked in administrative datasets.


Recruitment information / eligibility

Status Recruiting
Enrollment 1040
Est. completion date December 1, 2025
Est. primary completion date December 1, 2025
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years and older
Eligibility Inclusion Criteria: - Each agency will maintain their standard of care definition of eligibility for services. Generally, these criteria include: the client must be at least 21+ or 65+ years of age (depending on the agency) and the client's current living situation makes them a good fit for services. "Good fit for services" is up to the agency based on how they typically admit clients for services. Some factors that enter into the definition of a good fit include: the client must either be isolated, lacking in social ties that assist them, or their caregivers need respite services, in which case we provide them the same services as an isolated individual. Volunteer assistance must be vital to the client remaining in the home. Exclusion Criteria: - Participants under the age requirement for a given home will be excluded as will those who are deemed not a good fit for services. This might include clients who are not homebound or who's homes are in such poor condition that an agency doesn't feel the visiting companion would be safe.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Senior Companion Program
Receives a companion to socialize with them, help with daily tasks, etc.

Locations

Country Name City State
United States University of Notre Dame Notre Dame Indiana

Sponsors (6)

Lead Sponsor Collaborator
William Evans Catholic Charities of Southeast Michigan, Georgia Southern University, Health Association of Niagara County, Inc., Positive Maturity, Inc., The Evangelical Lutheran Good Samaritan Society

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Self-reported physical and mental health Self-reported physical and mental health as measured on follow-up surveys. These items are highly predictive of mortality. 6- and 18-months after study enrollment
Primary Difference in rates of self-reported loneliness between treatment and control groups The research team will use survey data to quantify the effect of receiving a senior companion on self-reported loneliness 6- and 18-months after study enrollment. 6- and 18-months after study enrollment
Primary Difference in rates of self-reported life satisfaction between treatment and control groups The research team will use survey data to quantify the effect of receiving a senior companion on self-reported life satisfaction 6- and 18-months after study enrollment. 6- and 18-months after study enrollment
Primary Difference in rates of self-reported independent living status between treatment and control groups The research team will use survey data to quantify the effect of receiving a senior companion on self-reported independent living status 6- and 18-months after study enrollment. 6- and 18-months after study enrollment
Primary Difference in mortality rates of between treatment and control groups The research team will match participants in the study to the Social Security Administration's Master Death File to determine deaths among the study participants to quantify the effect of receiving a senior companion on mortality. 6- and 18-months after study enrollment
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