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

Quality of Life Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05849259
• Other study ID #: 2022P003057
• Status: Recruiting
• Phase: N/A
• Start date: October 16, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: October 2023
• Source: Massachusetts General Hospital
• Contact: Maimouna Sy, BS
• Phone: 617-643-9070
• Email: masy[@]mgh.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 98
• Est. completion date: September 30, 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Caregiver Stress
• Dementia
• Quality of Life

Intervention

Other:
• Dementia Care Quality at Home
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) seven 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.

Locations

Country	Name	City	State
United States	Queens Medical Center	Honolulu	Hawaii
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	Retirement Research Foundation

Country where clinical trial is conducted

United States, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Feasibility for the practice of recruiting patient/caregiver dyads	Percentage of eligible dyads who enroll.	Post-intervention (6 months)
Other	Feasibility for the practice of percent of racial and ethnic minorities recruited.	Percentage of eligible dyads who enroll who are racial and ethnic minorities.	Post-intervention (6 months)
Other	Feasibility for the practice to use care modules.	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 and the percent of audited modules that are completed.	Post-intervention (6 months)
Other	Feasibility for the practice of clinicians to engage with the tele-video case conference.	Percent of virtual meetings attended.	Post-intervention (6 months)
Other	Net promoter score	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.	Post-intervention (6 months)
Other	Acceptability of the intervention to caregivers and patient to participate in the intervention.	Percent of CGs invited to participate who agree to participate in the intervention.	Post-intervention (6 months)
Other	Heard and understood	A one-item measure of CGs who report that they felt heard and understood by the practice.	Pre and post intervention (prior to and 6 months after)
Other	Caregiver well-being	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.	Post-intervention (6 months)
Primary	Feasibility for the caregiver to engage with and complete baseline assessments.	The percentage of identified CGs who complete baseline assessments.	Baseline
Primary	Feasibility for the caregiver to access educational materials and community resources.	Percent of CGs will report using 1 or more materials provided by the practice.	Post-intervention (6 months)
Primary	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
Primary	Feasibility for the practice of assessing eligible patient/caregiver dyads.	Ability of practice to identify eligible patient/caregiver dyads (e.g., CG experiencing burden or distress).	Baseline
Primary	Feasibility for the practice to use patient and caregiver assessments.	Percent of practice personnel who conduct assessments that rate assessments as feasible to use and percent of audited assessments that are completed.	Post-intervention (6 months)