The PorchLight Project

Alzheimer Disease Clinical Trial

Official title:

The PorchLight Project

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05550727
• Other study ID #: STUDY00013917
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 23, 2022
• Est. completion date: June 30, 2026

Study information

• Verified date: December 2023
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 their proxies (e.g., family 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 513
• Est. completion date: June 30, 2026
• Est. primary completion date: June 30, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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, client, or proxy 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.

• Caregivers whose care recipient receives volunteer respite, and either the caregiver indicates their care recipient has memory loss or the care recipient has 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.

Note: When discrepancies in reported memory loss between caregivers and clients occur, data from both the caregiver and client will be included and it will be assumed that the client has memory loss. Due to the nature of the data, we expect discrepancies to exist and will document other decisions made during analysis.

Exclusion Criteria:

As data is made available, the UMN research team expects to receive survey data from all the clients, caregivers, 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, caregiver, 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

• Caregivers who do not indicate presence of memory loss for their care recipient.

In addition, any client, caregiver, 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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia
• Memory Disorders
• Memory Loss

Intervention

Other:
• PorchLight
The PorchLight Project intervention consists of three components: 1) CARES® Dementia Care Specialist online training modules; 2) a PorchLight Project training course; and 3) monthly check-in sessions.

Locations

Country	Name	City	State
United States	University of Minnesota (with Lutheran Social Service of Minnesota)	Minneapolis	Minnesota

Sponsors (5)

Lead Sponsor	Collaborator
University of Minnesota	Brown University, Johns Hopkins University, Lutheran Social Service of Minnesota, The University of Texas at Arlington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in Self-Efficacy (Fortinsky, Kercher, & Burant) [Caregivers only]	8-items regarding confidence in caregiving	Baseline, 6 months, and 12 months
Other	Change in Live Well at Home Rapid Screen [Clients only]	6-items regarding falls, caregiving, living status, and cognition	Baseline, 6 months, and 12 months
Other	Change in client service use [Caregivers only]	3-items regarding frequency of overnight hospitalization, emergency department visits, and outpatient visits; checklist of 13-items regarding community based long term service and support use. This measure was designed for LSS-MN to assess the proportion of clients using various services.	Baseline, 6 months, and 12 months
Other	Change in Experience/impact/satisfaction related to LSS programming [All participants]	Experience/impact related to LSS programming (Volunteers: 3 quantitative, 3 open-ended items; Clients: 11 quantitative and 2 open-ended items; Caregiver: 5 quantitative for caregiver, 9 quantitative items about care recipient, 2 open-ended items). These items were designed for LSS-MN to assess both the proportion of participants who are satisfied with LSS programming, and to provide qualitative data about their experience.	Baseline, 6 months, and 12 months
Primary	Change in Volunteer Competence [Volunteers only]	6-items assess the preparedness to provide visiting services for clients with a variety of conditions, including memory loss. This measure was designed for LSS-MN to determine the proportion of volunteers who indicate their level of preparedness.	Baseline, 6 months, and 12 months
Primary	Change in De Jong Gierveld Scale [Clients only]	6-items assessing loneliness	Baseline, 6 months, and 12 months
Primary	Change in Patient-Reported Outcomes Measurement Information System Global Health Scale [All participants]	10-items assessing physical health, mental health, and quality of life.	Baseline, 6 months, and 12 months
Primary	Change in Caregiver Burden [Caregivers only]	2-items regarding time spent caregiving (days, hours) and 1-item regarding stress associated with caregiving (0-10 scale). These measures were designed for LSS-MN to assess the proportion of caregivers indicating burden.	Baseline, 6 months, and 12 months
Secondary	Program Cost-Effectiveness	Incremental cost-effectiveness ratio (ICER) is the difference between the cost of the PorchLight Project and the usual LSS-MN Caregiver & Companion Services divided by the difference in the benefit (is the person with AD/ADRD's quality-adjusted life-years [QALYs]) between the PorchLight Project and the usual Caregiver & Companion Services.	12 months