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OpenTrials
Completed

NCT Number: NCT05849259

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

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.

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Key information

Conditions

Dementia Behavior Behavioral Symptoms Brain Diseases Caregiver Burden Caregiver Stress Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Quality of Life Stress, Psychological

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queens Medical Center, Honolulu, Hawaii, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dementia Care Quality at Home

Other

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) six 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.

Primary outcomes

  1. Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.

    Time frame: Baseline

    The percentage of identified caregivers who complete baseline assessments.

  2. Feasibility for the Caregiver to Access Educational Materials and Community Resources.

    Time frame: Post-intervention (6 months)

    Percent of caregivers will report using 1 or more materials provided by the practice.

  3. Feasibility for the Practice of Identifying Potential Patients/Caregivers

    Time frame: Baseline

    Ability of practice to generate list of their patients living with dementia using a questionnaire to the practice

  4. Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.

    Time frame: Baseline

    Ability of practice to identify eligible patient/caregiver dyads (e.g., caregiver experiencing burden or distress).

  5. Feasibility for the Practice to Use Baseline Assessments.

    Time frame: Post-intervention (6 months)

    Percent of practice personnel who conduct assessments that rate assessments as feasible to use

  6. Feasibility for the Practice to Complete Baseline Assessments

    Time frame: Post-intervention (6 months)

    The percent of audited assessments that are completed.

Secondary outcomes

  1. Feasibility for the Practice of Recruiting Patient/Caregiver Dyads

    Time frame: Pre-intervention

    Percentage of eligible dyads who enroll.

  2. Patient Quality of Life

    Time frame: 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.

  3. Heard and Understood

    Time frame: Post Intervention (6 months)

    A one-item measure of caregivers who report that they felt heard and understood by the practice.

  4. Caregivers - Net Promoter Score of Intervention

    Time frame: 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.

  5. Feasibility for the Practice to Use Care Modules.

    Time frame: 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

  6. Feasibility for the Practice to Complete Care Modules

    Time frame: Post Intervention (6-months)

    Percent of audited modules that are completed.

  7. Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.

    Time frame: Post-intervention (6 months)

    % of case conferences conducted with at least one staff member present from each site

  8. Acceptability of the Intervention to Caregivers to Participate in the Intervention.

    Time frame: Pre-intervention (baseline)

    Percent of caregivers invited to participate who agree to participate in the intervention.

  9. Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.

    Time frame: Pre-intervention (baseline)

    Percentage of eligible dyads who enroll who are racial and ethnic minorities.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Retirement Research Foundation

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 8, 2023
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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