- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05368480
Evaluating the Impact of Senior Companion Programs
Evaluating the Impact of Senior Companion Programs on Homebound Adults' Well-being and Independent Living Status
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: William N Evans, PhD
- Phone Number: 574-631-7039
- Email: wevans1@nd.edu
Study Contact Backup
- Name: Vivian W Crumlish, MEd
- Phone Number: 574-631-1669
- Email: vcrumlis@nd.edu
Study Locations
-
-
Indiana
-
Notre Dame, Indiana, United States, 46556
- Recruiting
- University of Notre Dame
-
Contact:
- Vivian W Crumlish, MEd
- Phone Number: 574-631-1669
- Email: vcrumlis@nd.edu
-
Contact:
- William Evans, PhD
- Phone Number: 574-631-7039
- Email: wevans1@nd.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Senior Companion
Receives a companion to socialize with them, help with daily tasks, etc.
|
Receives a companion to socialize with them, help with daily tasks, etc.
|
No Intervention: Control
Referred to other services available in the community
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Difference in rates of self-reported loneliness between treatment and control groups
Time Frame: 6- and 18-months after study enrollment
|
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
|
Difference in rates of self-reported life satisfaction between treatment and control groups
Time Frame: 6- and 18-months after study enrollment
|
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
|
Difference in rates of self-reported independent living status between treatment and control groups
Time Frame: 6- and 18-months after study enrollment
|
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
|
Difference in mortality rates of between treatment and control groups
Time Frame: 6- and 18-months after study enrollment
|
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
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Self-reported physical and mental health
Time Frame: 6- and 18-months after study enrollment
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: William N Evans, PhD, University of Notre Dame
- Principal Investigator: Sarah Kroeger, PhD, University of Notre Dame
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 22-04-7161
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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