Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care (NCT05849259) | Clinical Trial Compass
CompletedNot Applicable
Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care
United States50 participantsStarted 2023-10-16
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.
Timeframe: Baseline
2
Feasibility for the Caregiver to Access Educational Materials and Community Resources.
Timeframe: Post-intervention (6 months)
3
Feasibility for the Practice of Identifying Potential Patients/Caregivers
Timeframe: Baseline
4
Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.
Timeframe: Baseline
5
Feasibility for the Practice to Use Baseline Assessments.
Timeframe: Post-intervention (6 months)
6
Feasibility for the Practice to Complete Baseline Assessments