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

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

Non Recruiting
18 years and older
All
Phase N/A

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Overview

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.

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.

Eligibility

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 details
    Dementia
    Quality of Life
    Caregiver Stress

NCT05849259

Massachusetts General Hospital

20 August 2025

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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