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

NCT05849259 | Completed Results

• 1 other identifier: 2022P003057
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Dementia; Quality of Life; Caregiver Stress

Outcome Measures

Primary Outcomes (6)

• Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.

  The percentage of identified caregivers who complete baseline assessments.

  Baseline

• Feasibility for the Caregiver to Access Educational Materials and Community Resources.

  Percent of caregivers will report using 1 or more materials provided by the practice.

  Post-intervention (6 months)

• Feasibility for the Practice of Identifying Potential Patients/Caregivers

  Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice

  Baseline

• Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.

  Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).

  Baseline

• Feasibility for the Practice to Use Baseline Assessments.

  Percent of practice personnel who conduct assessments that rate assessments as feasible to use

  Post-intervention (6 months)

• Feasibility for the Practice to Complete Baseline Assessments

  The percent of audited assessments that are completed.

  Post-intervention (6 months)

Secondary Outcomes (9)

• Feasibility for the Practice of Recruiting Patient/Caregiver Dyads

  Pre-intervention

• Patient Quality of Life

  Pre-Intervention (baseline) and post-intervention (6 months)

• Heard and Understood

  Post Intervention (6 months)

• Caregivers - Net Promoter Score of Intervention

  Post-intervention (6 months)

• Feasibility for the Practice to Use Care Modules.

  Post-intervention (6 months)

Study Arms (1)

Dementia Care Quality at Home

EXPERIMENTAL

Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.

Other: Dementia Care Quality at Home

Interventions

Dementia Care Quality at Home OTHER

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) six 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.

Dementia Care Quality at Home

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Retirement Research Foundation: collaborator

Study Sites (2)

Queens Medical Center

Honolulu, Hawaii, 96813, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23219, United States

Location

Related Publications (31)

• Leff B, Ritchie C, Freeland DG, Jamshed N, Major A, Gallopyn N, Sharieff S, Taylor J, Yudin JA, Sheehan OC. The National Home-Based Primary Care Learning Network: A Practice-Based Quality Improvement and Research Network. J Am Med Dir Assoc. 2022 Aug;23(8):1424-1426. doi: 10.1016/j.jamda.2022.02.017. Epub 2022 Mar 26.

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  BACKGROUND

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  BACKGROUND

• Medical care at home comes of age. [Internet]. California Health Care Foundation. 2021[cited 2022 Apr 25]; Available from: https://www.chcf.org/publication/medical-care-home-comes-age/

  BACKGROUND

• Lucero KS. Net Promoter Score (NPS): What Does Net Promoter Score Offer in the Evaluation of Continuing Medical Education? J Eur CME. 2022 Nov 29;11(1):2152941. doi: 10.1080/21614083.2022.2152941. eCollection 2022.

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• Ritchie C, Leff B, Sy M, Thacker A, Donelan K, Forester B, Sheehan OC; Dementia Care Quality at Home Writing Group. Feasibility and Acceptability of a Clinician-Caregiver Co-Designed Dementia Care Intervention for Home-Based Primary Care. J Am Geriatr Soc. 2025 Dec;73(12):3849-3858. doi: 10.1111/jgs.70112. Epub 2025 Sep 21.

  PMID: 40976934 DERIVED

• Sy M, Thacker A, Sheehan OC, Leff B, Ritchie CS. Caring for caregivers and persons living with dementia under home-based primary care: protocol for an interventional clinical trial. Pilot Feasibility Stud. 2024 Feb 9;10(1):28. doi: 10.1186/s40814-024-01455-x.

  PMID: 38336779 DERIVED

MeSH Terms

Conditions

Dementia; Caregiver Burden

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Dr. Christine S Ritchie
• Organization: Massachusetts General Hospital

csritchie@mgh.harvard.edu

415-672-1780

Study Officials

• Christine S Ritchie, MD, MSPH

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Bruce Leff, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

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

Study Record Dates

• First Submitted: April 7, 2023
• First Posted: May 8, 2023
• Study Start: October 16, 2023
• Primary Completion: October 31, 2024
• Study Completion: December 20, 2024
• Last Updated: September 25, 2025
• Results First Posted: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)