Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05849259

Collaborator

Retirement Research Foundation (Other)

Enrollment

Locations

Arm

Anticipated Duration (Months)

Patients Per Site

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this clinical trial is to develop a dementia care intervention for persons receiving home-based primary care (HBPC) and living with dementia (PLWD) and their caregivers, and test the feasibility of implementing the intervention in HBPC practices to ultimately improve outcomes of PLWD and their caregivers.

The main aims are to:

Develop and refine HBPC Dementia Care Quality at Home
Establish feasibility (primary outcome), acceptability, and fidelity of HBPC Dementia Care Quality at Home through an open-pilot trial involving two HBPC practices. Trained clinicians and staff at two HBPC practices will implement the intervention

Relevant stakeholders (caregivers of PLWD, and HBPC clinicians and staff) will participate in qualitative focus groups to provide feedback on the intervention.

Condition or Disease	Intervention/Treatment	Phase
Dementia Quality of Life Caregiver Stress	Other: Dementia Care Quality at Home	N/A

Detailed Description

The overarching goal of this project is to develop a dementia care intervention for PLWD and their caregivers, Dementia Care Quality at Home, and test the feasibility of implementing the intervention in two HBPC practices to ultimately improve outcomes of PLWD and their caregivers.

The investigators will evaluate the feasibility, acceptability, and fidelity in implementing HBPC Dementia Care Quality at Home in two practices for persons living with dementia and their caregivers through an open pilot. Hypothesis: HBPC Dementia Care Quality at Home will meet benchmarks of feasibility, acceptability, and fidelity by the HBPC practices implementing it and by caregivers of PLWD who experience the intervention. The investigators will assess feasibility of caregivers of PLWD to engage with the intervention, the acceptability of the intervention to caregivers, and the impact of the intervention on caregiver well-being by surveying caregivers at the conclusion of the pilot. In addition, the investigators will assess feasibility, acceptability, and fidelity of the intervention in the practices.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

A live open-pilot trial will be conducted of the HBPC Dementia Care Quality at Home intervention in two HBPC practices.A live open-pilot trial will be conducted of the HBPC Dementia Care Quality at Home intervention in two HBPC practices.

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Jul 1, 2024

Anticipated Study Completion Date :

Sep 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dementia Care Quality at Home Each HBPC practice will receive the Dementia Care Quality at Home intervention.	Other: Dementia Care Quality at Home Each of the two HBPC practices will identify at least two trained Dementia Care Quality at Home Champions who will be trained in the intervention comprised of 1) a standardized assessment tool to assess PLWD and caregiver needs; 2) seven modules created to optimize the well-being of the PLWD and their caregiver; and 3) regular team-based review of persons participating in the program to address care challenges and a team-based case conference approach to solve these challenges.

Arm

Intervention/Treatment

Experimental: Dementia Care Quality at Home

Each HBPC practice will receive the Dementia Care Quality at Home intervention.

Other: Dementia Care Quality at Home

Each of the two HBPC practices will identify at least two trained Dementia Care Quality at Home Champions who will be trained in the intervention comprised of 1) a standardized assessment tool to assess PLWD and caregiver needs; 2) seven modules created to optimize the well-being of the PLWD and their caregiver; and 3) regular team-based review of persons participating in the program to address care challenges and a team-based case conference approach to solve these challenges.

Outcome Measures

Primary Outcome Measures

Feasibility for the caregiver to engage with and complete baseline assessments. [Baseline]
The percentage of identified CGs who complete baseline assessments.
Feasibility for the caregiver to access educational materials and community resources. [Post-intervention (6 months)]
Percent of CGs will report using 1 or more materials provided by the practice.
Feasibility for the practice of identifying potential patients/caregivers [Baseline]
Ability of practice to generate list of their patients living with dementia.
Feasibility for the practice of assessing eligible patient/caregiver dyads. [Baseline]
Ability of practice to identify eligible patient/caregiver dyads (e.g., CG experiencing burden or distress).
Feasibility for the practice to use patient and caregiver assessments. [Post-intervention (6 months)]
Percent of practice personnel who conduct assessments that rate assessments as feasible to use and percent of audited assessments that are completed.

Other Outcome Measures

Feasibility for the practice of recruiting patient/caregiver dyads [Post-intervention (6 months)]
Percentage of eligible dyads who enroll.
Feasibility for the practice of percent of racial and ethnic minorities recruited. [Post-intervention (6 months)]
Percentage of eligible dyads who enroll who are racial and ethnic minorities.
Feasibility for the practice to use care modules. [Post-intervention (6 months)]
The percentage that rates modules as feasible to use. The percentage of practice personnel who complete the modules that rate the modules as feasible to use and the percent of audited modules that are completed.
Feasibility for the practice of clinicians to engage with the tele-video case conference. [Post-intervention (6 months)]
Percent of virtual meetings attended.
Net promoter score [Post-intervention (6 months)]
The single question - "How likely are you to recommend X to a friend [or colleague]?" is rated from 0 - Not at all likely to 10 - Extremely likely.
Acceptability of the intervention to caregivers and patient to participate in the intervention. [Post-intervention (6 months)]
Percent of CGs invited to participate who agree to participate in the intervention.
Heard and understood [Pre and post intervention (prior to and 6 months after)]
A one-item measure of CGs who report that they felt heard and understood by the practice.
Caregiver well-being [Post-intervention (6 months)]
Quality of Life in Alzheimer's Disease. The QoL-AD is comprised of 13 items (physical health, energy, mood, living situation, memory, family, marriage, friends, self as a whole, ability to do chores, ability to do things for fun, money and life as a whole). Response options include 1(poor), 2(fair), 3(good) and 4 (excellent), for a total score of 13-52, with higher scores indicating better QoL.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Caregiver participants will:

be adults (18 years or older)
have English fluency and literacy
live in the United States
live with and care for an individual with Alzheimer's Disease and Alzheimer's Disease Related Dementias (ADRD)
anticipate providing care for the next 6 months
provide an average 4 hours of supervision or direct assistance per day for the care recipient and
have been identified by the practice as experiencing caregiver stress.

Staff participants will:

be 18 years or older
have English fluency and literacy and live in the United States and
be part of a HBPC primary care program or closely connected to the practice.

Exclusion Criteria:

Participants under the age 18.
Participants who have no English fluency and literacy and do not live in the United States.
For caregiver participants, not caring for and living with a patient that is part of a HBPC primary care program or closely connected to the practice.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Queens Medical Center	Honolulu	Hawaii	United States	96813
2	Virginia Commonwealth University	Richmond	Virginia	United States	23219

Sponsors and Collaborators

Massachusetts General Hospital
Retirement Research Foundation

Investigators

Principal Investigator: Christine S Ritchie, MD, MSPH, Massachusetts General Hospital
Principal Investigator: Bruce Leff, MD, Johns Hopkins University

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Christine S. Ritchie, MD, MPH, Professor of Medicine, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT05849259

Other Study ID Numbers:

2022P003057

First Posted:

May 8, 2023

Last Update Posted:

May 8, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Study Results

No Results Posted as of May 8, 2023