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Active, Not Recruiting

NCT Number: NCT05550727

The PorchLight Project

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Memory Loss Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota (with Lutheran Social Service of Minnesota)

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Volunteer Competence [Volunteers only]

    Time frame: Baseline, 6 months, and 12 months

    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.

  2. Change in De Jong Gierveld Scale [Clients only]

    Time frame: Baseline, 6 months, and 12 months

    6-items assessing loneliness

  3. Change in Patient-Reported Outcomes Measurement Information System Global Health Scale [All participants]

    Time frame: Baseline, 6 months, and 12 months

    10-items assessing physical health, mental health, and quality of life.

Secondary outcomes

  1. Program Cost-Effectiveness

    Time frame: 12 months

    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.

Other outcomes

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

    Time frame: Baseline, 6 months, and 12 months

    6-items regarding falls, caregiving, living status, and cognition

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

    Time frame: Baseline, 6 months, and 12 months

    Experience/impact related to LSS programming (Volunteers: 3 quantitative, 3 open-ended items; Clients: 11 quantitative and 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.

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

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

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 22, 2022
Registry last updated
Dec 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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