NCT05368480

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,040

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 2, 2022

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 1, 2022

Status Verified

May 1, 2022

Enrollment Period

3.6 years

First QC Date

May 5, 2022

Last Update Submit

May 25, 2022

Conditions

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Other Outcomes (1)

  • Self-reported physical and mental health

    6- and 18-months after study enrollment

Study Arms (2)

Senior Companion

EXPERIMENTAL

Receives a companion to socialize with them, help with daily tasks, etc.

Other: Senior Companion Program

Control

NO INTERVENTION

Referred to other services available in the community

Interventions

Receives a companion to socialize with them, help with daily tasks, etc.

Senior Companion

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Notre Dame

Notre Dame, Indiana, 46556, United States

RECRUITING

Study Officials

  • William N Evans, PhD

    University of Notre Dame

    PRINCIPAL INVESTIGATOR
  • Sarah Kroeger, PhD

    University of Notre Dame

    PRINCIPAL INVESTIGATOR

Central Study Contacts

William N Evans, PhD

CONTACT

Vivian W Crumlish, MEd

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Clients will be kept on a waitlist. When a companion becomes available in a particular geographic area, the agency will take the top two on the list with corresponding geographies, complete an intake interview for both and then use a computer to randomly assign one to treatment (receiving the companion) and one to control (referrals to other services).
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Dr. William Evans, Keough Hesburgh Professor of Economics

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 10, 2022

Study Start

May 2, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

June 1, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

We plan to create a de-identified dataset of participant data, which we will make available for other researchers. This dataset will contain the data necessary to replicate the analysis detailed in publications resulting from the study. We will only share data in a manner consistent with data sharing agreements which we establish with data providers. These data sharing agreements are still in process, so while we plan to share de-identified data at this time, we will only do so if our data sharing agreements allow it.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
We will make data available when we release a publication resulting from the study. There will not be an end date for when data will be available.
Access Criteria
We will make our dataset available to the general public by posting it on the website for the Inter-University Consortium for Political and Social Research (ICPSR).

Locations