Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care
- Conditions
- Caregiver StressDementiaQuality of Life
- Registration Number
- NCT05849259
- Lead Sponsor
- Massachusetts General Hospital
- 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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Feasibility for the Caregiver to Engage With and Complete Baseline Assessments. Baseline The percentage of identified caregivers who complete baseline assessments.
Feasibility for the Caregiver to Access Educational Materials and Community Resources. Post-intervention (6 months) Percent of caregivers 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 using a questionnaire to the practice
Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads. Baseline Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).
Feasibility for the Practice to Use Baseline Assessments. Post-intervention (6 months) Percent of practice personnel who conduct assessments that rate assessments as feasible to use
Feasibility for the Practice to Complete Baseline Assessments Post-intervention (6 months) The percent of audited assessments that are completed.
- Secondary Outcome Measures
Name Time Method Feasibility for the Practice of Recruiting Patient/Caregiver Dyads Pre-intervention Percentage of eligible dyads who enroll.
Caregivers - Net Promoter Score of Intervention 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.
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
Feasibility for the Practice to Complete Care Modules Post Intervention (6-months) Percent of audited modules that are completed.
Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited. Pre-intervention (baseline) Percentage of eligible dyads who enroll who are racial and ethnic minorities.
Patient Quality of Life Pre-Intervention (baseline) and 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.
Heard and Understood Post Intervention (6 months) A one-item measure of caregivers who report that they felt heard and understood by the practice.
Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference. Post-intervention (6 months) % of case conferences conducted with at least one staff member present from each site
Acceptability of the Intervention to Caregivers to Participate in the Intervention. Pre-intervention (baseline) Percent of caregivers invited to participate who agree to participate in the intervention.
Trial Locations
- Locations (2)
Queens Medical Center
🇺🇸Honolulu, Hawaii, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Queens Medical Center🇺🇸Honolulu, Hawaii, United States