Recruiting

Observational Study

Sponsor:

William Evans

Code:

NCT05368480

Conditions

Aging

Disabilities Multiple

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Senior Companion Program

Study Details

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.

Conditions

Aging

Disabilities Multiple

Study ID

NCT05368480

Start date

May 2, 2022

Status verified date

May, 2022

Completion date

Dec 1, 2025

Anticipated

Primary completion date

Dec 1, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

1040 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Senior Companion

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

no intervention: Control

Referred to other services available in the community

Interventions

Senior Companion Program

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

Primary outcome measure

  • Difference in rates of self-reported loneliness between treatment and control groups [ Time Frame: 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 ]
  • Difference in rates of self-reported independent living status between treatment and control groups [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

William N Evans, PhD

574-631-7039wevans1@nd.edu

Vivian W Crumlish, MEd

574-631-1669vcrumlis@nd.edu

Locations

University of Notre Dame

Recruiting

Notre Dame, Indiana, United States, 46556

Contacts

William Evans, PhD

574-631-7039wevans1@nd.edu

Vivian W Crumlish, MEd

574-631-1669vcrumlis@nd.edu

More Information

Sponsor

William Evans

Last update posted

Jun 1, 2022

Last verified

May, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by William Evans on 2022-06-01.