N/A N=50 Supportive Care

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

Dementia · Quality of Life · Caregiver Stress

Bottom Line

View on ClinicalTrials.gov: NCT05849259 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2025

Primary outcome: Primary: Feasibility for the Caregiver to Engage With and Complete Baseline Assessments. — 50 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Dementia Care Quality at Home (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Massachusetts General Hospital
Primary completion: Oct 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.	50	—
PRIMARY Feasibility for the Caregiver to Access Educational Materials and Community Resources.	50	—
PRIMARY Feasibility for the Practice of Identifying Potential Patients/Caregivers	18	—
PRIMARY Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.	18	—
PRIMARY Feasibility for the Practice to Use Baseline Assessments.	18	—
PRIMARY Feasibility for the Practice to Complete Baseline Assessments	7	—
SECONDARY Feasibility for the Practice of Recruiting Patient/Caregiver Dyads	50	—
SECONDARY Patient Quality of Life	25.5; 28.5	—
SECONDARY Heard and Understood	37	—
SECONDARY Caregivers - Net Promoter Score of Intervention	8.8	—
SECONDARY Feasibility for the Practice to Use Care Modules.	18	—
SECONDARY Feasibility for the Practice to Complete Care Modules	11	—
SECONDARY Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.	25	—
SECONDARY Acceptability of the Intervention to Caregivers to Participate in the Intervention.	50	—
SECONDARY Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.	26	—

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.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05849259). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.