Clinical trial NCT05550727: The PorchLight Project
Official title: The PorchLight Project
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Memory Loss
Alzheimer Disease
Dementia
Lead sponsor: University of Minnesota
Sponsor class: OTHER
Collaborators: name: Lutheran Social Service of Minnesota
name: Brown University
name: The University of Texas at Arlington
First posted: 2022-09-22
Enrollment: 342
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed project is a fully embedded pragmatic trial (R01), following an R61 pilot collaboration with Lutheran Social Service of Minnesota (LSS-MN).

For this project: a) the training program for Senior Companions that was developed in the R61 Phase will now be delivered as part of a routine onboarding process provided by LSS-MN to all senior support volunteers in half of their program regions across Minnesota; LSS-MN will offer the PorchLight Project program to all regions and volunteers in the state during the final months of the proposed NIA project, consistent with quality improvement approaches; and b) LSS-MN will administer regular surveys to volunteers, clients, and caregivers as part of ongoing tracking and quality improvement efforts. The University of Minnesota investigators will not collect data nor administer training, as these activities will be fully integrated into the workflow of LSS-MN. \[Note: Since it was learned that caregivers receiving services/affiliated with LSS-MN programming who receive surveys are for the most part not providing care to LSS-MN clients, as of fall 2024, UMN will no longer request and analyze data on LSS-MN caregivers.\]

UNIVERSITY OF MINNESOTA INVOLVEMENT:

The University of Minnesota and collaborating investigators outside of LSS-MN will only 1) assist in survey item selection, 2) randomize the LSS-MN regions for the initial phases of the real-world trial for evaluation purposes, 3) analyze the de-identified data shared by LSS-MN, and 4) disseminate the project results in scientific, practice, and policy outlets/contexts.


Eligibility criteria: The eligibility criteria of volunteers, persons with AD/ADRD, and their caregivers is deliberately lax in order to best reflect LSS-MN "routine practice." Participants must be either a volunteer or client involved in the LSS-MN standard Caregiver \& Companion Program service program. Programmatic and survey data on the volunteers, clients, and proxies involved will be shared with the UMN team. While all data received may be analyzed (see analysis section below), data analysis is expected to focus on those who meet the following additional criteria:

* Volunteers who are listed in the LSS database.
* Clients with cognitive concerns (i.e. minor confusion, memory loss, diagnosis for their memory loss, or concerns about cognition) via the LSS-MN surveys and/or the LSS-MN CRM database.

If memory loss is indicated via the database or survey, it will be assumed that the client has memory loss, even if there are discrepancies. Due to the nature of the data, we expect discrepancies to exist and will document other decisions made during analysis.

Note: Due to the general ineligibility of caregivers (caregivers in LSS-MN programming are not generally caring for care recipients receiving LSS-MN respite programming), caregiver data will not be used for PorchLight analysis any longer.

Exclusion Criteria:

As data is made available, the UMN research team expects to receive survey data from all the clients and volunteers in LSS-MN Caregiver \& Companion Services programming who complete the surveys, and those included in the LSS database. Since LSS-MN administers surveys to every client and volunteer involved in their LSS-MN Caregiver \& Companion program (as able), data likely will be obtained from individuals who do not meet the memory-specific criteria. However, as needed, UMN may choose to exclude one or more of the following from analysis. Again, the researcher/research staff best judgement will be used when conducting analyses and will document decisions accordingly:

● Clients who do not have memory loss

In addition, any client and volunteer can choose to not complete surveys, so we would not have survey data from those individuals, and may continue with routine attempts at surveying at the next data collection time-point. Missing surveys may be considered during analysis.

Please note: Due to the eligibility criteria for volunteers and clients in the LSS-MN program, we do not anticipate any data for those under 18 years of age. Although the real-world, pragmatic design will allow us to include caregivers under the age of 21), it is important to note that LSS-MN's most recent data on caregivers participating in their volunteer programs indicate none under the age of 21

Primary outcomes:
measure: Change in Volunteer Competence [Volunteers only]
timeFrame: Baseline, 6 months, and 12 months
measure: Change in De Jong Gierveld Scale [Clients only]
timeFrame: Baseline, 6 months, and 12 months
measure: Change in Patient-Reported Outcomes Measurement Information System Global Health Scale [All participants]
timeFrame: Baseline, 6 months, and 12 months
Secondary outcomes:
measure: Program Cost-Effectiveness
timeFrame: 12 months
Other outcomes:
measure: Change in Live Well at Home Rapid Screen [Clients only]
timeFrame: Baseline, 6 months, and 12 months
measure: Change in Experience/impact/satisfaction related to LSS programming [All participants]
timeFrame: Baseline, 6 months, and 12 months
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota (with Lutheran Social Service of Minnesota)
state: Minnesota
Study officials:
References: