The PorchLight Project

NCT05550727 | Active Not Recruiting DMC

• 1 other identifier: STUDY00013917
• Study Type: interventional
• Target: 342
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Loss; Alzheimer Disease; Dementia

Outcome Measures

Primary Outcomes (3)

• 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

• Change in De Jong Gierveld Scale [Clients only]

  6-items assessing loneliness

  Baseline, 6 months, and 12 months

• 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

Secondary Outcomes (1)

• Program Cost-Effectiveness

  12 months

Other Outcomes (2)

• Change in Live Well at Home Rapid Screen [Clients only]

  Baseline, 6 months, and 12 months

• Change in Experience/impact/satisfaction related to LSS programming [All participants]

  Baseline, 6 months, and 12 months

Study Arms (2)

PorchLight

EXPERIMENTAL

Other: PorchLight

Control

NO INTERVENTION

Interventions

PorchLight OTHER

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.

PorchLight

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• In keeping with the incorporation of pragmatic design elements, the eligibility criteria of volunteers and persons with AD/ADRD 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 programs. 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Minnesota: lead
• Lutheran Social Service of Minnesota: collaborator
• Brown University: collaborator
• The University of Texas at Arlington: collaborator

Study Sites (1)

University of Minnesota (with Lutheran Social Service of Minnesota)

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Memory Disorders; Alzheimer Disease; Dementia

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: September 22, 2022
• Study Start: September 23, 2022
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: December 17, 2025

Record last verified: 2025-12

Locations

US (1)