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

Mass General Brigham

Status: Completed

Conditions: Quality of Life; Caregiver Stress; Dementia

Treatments: Other: Dementia Care Quality at Home

Study type: Interventional

Funder types: Other

Identifiers

NCT05849259

2022P003057

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Dementia Care Quality at Home

Experimental group

Description:

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

Treatment:

Other: Dementia Care Quality at Home