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The PorchLight Project

Primary Purpose

Memory Loss, Alzheimer Disease, Dementia

Status

Active

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

PorchLight

About this trial

This is an interventional supportive care trial for Memory Loss

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Screening:

All screening of volunteers, clients, and caregivers will occur outside of the context of this project and in line with standard practices by LSS-MN Caregiver & Companion Service programs.

The eligibility criteria of volunteers, persons with AD/ADRD, and their caregivers is deliberately lax in order to best reflect LSS-MN "routine practice."

Inclusion Criteria:

1) A Volunteer, client, or proxy involved in the LSS-MN standard Caregiver & Companion Program service program.

Note: De-identified programmatic and survey data on the volunteers, clients, and proxies involved will be shared with the UMN team. While all de-identified data received may be analyzed, data analysis is expected to focus on those who meet the following additional criteria:

Volunteers who completed LSS-MN required training components.
Clients who report memory loss and/or a diagnosis for their memory loss, via the LSS-MN surveys.
Caregivers whose care recipient has memory loss and/or diagnosis for their memory loss based on LSS survey responses.

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. Since LSS-MN administers surveys to every client, caregiver, and volunteer involved in their LSS-MN Caregiver & Companion program (as able), de-identified 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
Treatment group volunteers not completing required LSS-MN PorchLight program training
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

Sites / Locations

University of Minnesota (with Lutheran Social Service of Minnesota)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PorchLight

Control

Arm Description

Outcomes

Primary Outcome Measures

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.

Change in De Jong Gierveld Scale [Clients only]

6-items assessing loneliness

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

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

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.

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT05550727

First Posted

August 8, 2022

Last Updated

February 23, 2023

Sponsor

University of Minnesota

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05550727

Brief Title

The PorchLight Project

Official Title

The PorchLight Project

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

September 23, 2022 (Actual)

Primary Completion Date

June 30, 2026 (Anticipated)

Study Completion Date

June 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Minnesota

Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Memory Loss, Alzheimer Disease, Dementia

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Model Description

This study doesn't use any drugs or devices and is exempt from IRB approval requirements.

Masking

None (Open Label)

Allocation

Randomized

Enrollment

513 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PorchLight

Arm Type

Experimental

Arm Title

Control

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

PorchLight

Intervention Description

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 Outcome Measure Information:

Title

Change in Volunteer Competence [Volunteers only]

Description

Time Frame

Baseline, 6 months, and 12 months

Title

Change in De Jong Gierveld Scale [Clients only]

Description

6-items assessing loneliness

Time Frame

Baseline, 6 months, and 12 months

Title

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

Description

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

Time Frame

Baseline, 6 months, and 12 months

Title

Change in Caregiver Burden [Caregivers only]

Description

Time Frame

Baseline, 6 months, and 12 months

Secondary Outcome Measure Information:

Title

Program Cost-Effectiveness

Description

Time Frame

12 months

Other Pre-specified Outcome Measures:

Title

Change in Self-Efficacy (Fortinsky, Kercher, & Burant) [Caregivers only]

Description

8-items regarding confidence in caregiving

Time Frame

Baseline, 6 months, and 12 months

Title

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

Description

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

Time Frame

Baseline, 6 months, and 12 months

Title

Change in client service use [Caregivers only]

Description

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.

Time Frame

Baseline, 6 months, and 12 months

Title

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

Description

Experience/impact related to LSS programming (Volunteers: 3 quantitative, 1 open-ended item; Clients: 11 quantitative and 1 open-ended item; Family: 5 quantitative for caregiver, 9 quantitative items about care recipient, 1 open-ended item). 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.

Time Frame

Baseline, 6 months, and 12 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Screening: All screening of volunteers, clients, and caregivers will occur outside of the context of this project and in line with standard practices by LSS-MN Caregiver & Companion Service programs. The eligibility criteria of volunteers, persons with AD/ADRD, and their caregivers is deliberately lax in order to best reflect LSS-MN "routine practice." Inclusion Criteria: 1) A Volunteer, client, or proxy involved in the LSS-MN standard Caregiver & Companion Program service program. Note: De-identified programmatic and survey data on the volunteers, clients, and proxies involved will be shared with the UMN team. While all de-identified data received may be analyzed, data analysis is expected to focus on those who meet the following additional criteria: Volunteers who completed LSS-MN required training components. Clients who report memory loss and/or a diagnosis for their memory loss, via the LSS-MN surveys. Caregivers whose care recipient has memory loss and/or diagnosis for their memory loss based on LSS survey responses. 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. Since LSS-MN administers surveys to every client, caregiver, and volunteer involved in their LSS-MN Caregiver & Companion program (as able), de-identified 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 Treatment group volunteers not completing required LSS-MN PorchLight program training 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

Facility Information:

Facility Name

University of Minnesota (with Lutheran Social Service of Minnesota)

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55455

Country

United States

12. IPD Sharing Statement

Learn more about this trial

The PorchLight Project

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