AgingNCT05368480
Evaluating the Impact of Senior Companion Programs
A study testing Senior Companion Program in people with Aging and Disabilities Multiple, run by William Evans at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Disabilities Multiple
- What is being tested?
- Senior Companion Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,040 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2022to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Notre Dame
Notre Dame, Indiana, 46556
William Evans, PhD, 574-631-7039, wevans1@nd.edu
Vivian W Crumlish, MEd, 574-631-1669, vcrumlis@nd.edu
About this study
Official title: Evaluating the Impact of Senior Companion Programs on Homebound Adults' Well-being and Independent Living Status
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.
Read the 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.
- Conditions
- Aging, Disabilities Multiple
- Being tested
- Senior Companion Program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Senior Companion ProgramOther
Receives a companion to socialize with them, help with daily tasks, etc.
| Study group | Role | What they receive |
|---|---|---|
| Senior Companion | Experimental | Receives a companion to socialize with them, help with daily tasks, etc. Receives: Other: Senior Companion Program |
| Control | No intervention | Referred to other services available in the community |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6- and 18-months after study enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start2 May 2022
- Primary completion1 Dec 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 1,040 participants (estimated)
Sponsor and investigators
- Lead sponsor
- William Evans
- Sponsor type
- University, hospital or other
- Collaborators
- Health Association of Niagara County, Inc., Catholic Charities, Georgia Southern University, The Evangelical Lutheran Good Samaritan Society, Positive Maturity, Inc.
- Responsible party
- Sponsor-investigator, William Evans, University of Notre Dame
- Investigators
- William N Evans, PhD, Principal investigator, University of Notre DameSarah Kroeger, PhD, Principal investigator, University of Notre Dame
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05368480
- Sponsor's protocol ID
- 22-04-7161
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Impact of Senior Companion Programs on Homebound Adults' Well-being and Independent Living Status
- ClinicalTrials.gov ID
- NCT05368480
- Acronym / sponsor ID
- 22-04-7161
- Conditions
- Aging, Disabilities Multiple
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,040 participants (estimated)
- Lead sponsor
- William EvansUniversity, hospital or other
- Collaborators
- Health Association of Niagara County, Inc., Catholic Charities, Georgia Southern University, The Evangelical Lutheran Good Samaritan Society, Positive Maturity, Inc.
- Study start
- 2 May 2022 (actual)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 10 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Senior Companion | Experimental | Other: Senior Companion ProgramReceives a companion to socialize with them, help with daily tasks, etc. |
| Control | No intervention | –Referred to other services available in the community |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Senior Companion ProgramReceives a companion to socialize with them, help with daily tasks, etc. | Other | Senior Companion |
Primary outcome
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.
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William N Evans, PhD principal investigator
University of Notre Dame
Sarah Kroeger, PhD principal investigator
University of Notre Dame
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Senior Companion Program in people with Aging and Disabilities Multiple, run by William Evans at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact William N Evans, PhD (574-631-7039, wevans1@nd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in rates of self-reported loneliness between treatment and control groups (time frame: 6- and 18-months after study enrollment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2022.