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

October 16, 2023 updated by: Christine S. Ritchie, MD, MPH, Massachusetts General Hospital

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

98

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
    • Virginia
      • Richmond, Virginia, United States, 23219

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility for the caregiver to engage with and complete baseline assessments.
Time Frame: Baseline
The percentage of identified CGs who complete baseline assessments.
Baseline
Feasibility for the caregiver to access educational materials and community resources.
Time Frame: Post-intervention (6 months)
Percent of CGs will report using 1 or more materials provided by the practice.
Post-intervention (6 months)
Feasibility for the practice of assessing eligible patient/caregiver dyads.
Time Frame: Baseline
Ability of practice to identify eligible patient/caregiver dyads (e.g., CG experiencing burden or distress).
Baseline
Feasibility for the practice to use patient and caregiver assessments.
Time Frame: 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.
Post-intervention (6 months)
Feasibility for the practice of identifying potential patients/caregivers
Time Frame: Baseline
Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice
Baseline

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility for the practice of recruiting patient/caregiver dyads
Time Frame: Post-intervention (6 months)
Percentage of eligible dyads who enroll.
Post-intervention (6 months)
Feasibility for the practice of percent of racial and ethnic minorities recruited.
Time Frame: Post-intervention (6 months)
Percentage of eligible dyads who enroll who are racial and ethnic minorities.
Post-intervention (6 months)
Feasibility for the practice to use care modules.
Time Frame: 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.
Post-intervention (6 months)
Feasibility for the practice of clinicians to engage with the tele-video case conference.
Time Frame: Post-intervention (6 months)
Percent of virtual meetings attended.
Post-intervention (6 months)
Net promoter score
Time Frame: 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.
Post-intervention (6 months)
Acceptability of the intervention to caregivers and patient to participate in the intervention.
Time Frame: Post-intervention (6 months)
Percent of CGs invited to participate who agree to participate in the intervention.
Post-intervention (6 months)
Heard and understood
Time Frame: 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.
Pre and post intervention (prior to and 6 months after)
Caregiver well-being
Time Frame: 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.
Post-intervention (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Massachusetts General Hospital

Collaborators

Retirement Research Foundation

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 16, 2023

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

September 30, 2024

Study Registration Dates

First Submitted

April 7, 2023

First Submitted That Met QC Criteria

May 5, 2023

First Posted (Actual)

May 8, 2023

Study Record Updates

Last Update Posted (Actual)

October 18, 2023

Last Update Submitted That Met QC Criteria

October 16, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022P003057

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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