NCT05849259

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

Completed NA Results posted Last updated 25 September 2025

What this trial tests

NA trial testing Dementia Care Quality at Home in Dementia in 50 participants. Completed in 20 December 2024.

Timeline

16 October 2023

Primary endpoint
31 October 2024

20 December 2024

Quick facts

Lead sponsor	Massachusetts General Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	50
Start date	16 October 2023
Primary completion	31 October 2024
Estimated completion	20 December 2024
Sites	2 locations across United States

Drugs / interventions tested

• Dementia Care Quality at Home

Conditions studied

• Dementia — all drugs for Dementia →
• Quality of Life — all drugs for Quality of Life →
• Caregiver Stress — all drugs for Caregiver Stress →

Sponsor

Massachusetts General Hospital

Who can join

18 and older, any sex, with Dementia or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

The percentage of identified caregivers who complete baseline assessments.

Group	Value	95% CI
Dementia Care Quality at Home	50

Feasibility for the Caregiver to Access Educational Materials and Community Resources. Primary · Post-intervention (6 months)

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

Group	Value	95% CI
Dementia Care Quality at Home	50

Feasibility for the Practice of Identifying Potential Patients/Caregivers Primary · Baseline

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

Group	Value	95% CI
Dementia Care Quality at Home	18

Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads. Primary · Baseline

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

Group	Value	95% CI
Dementia Care Quality at Home	18

Feasibility for the Practice to Use Baseline Assessments. Primary · Post-intervention (6 months)

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

Group	Value	95% CI
Dementia Care Quality at Home	18

Feasibility for the Practice to Complete Baseline Assessments Primary · Post-intervention (6 months)

The percent of audited assessments that are completed.

Group	Value	95% CI
Dementia Care Quality at Home	7

Feasibility for the Practice of Recruiting Patient/Caregiver Dyads Secondary · Pre-intervention

Percentage of eligible dyads who enroll.

Group	Value	95% CI
Dementia Care Quality at Home	50

Patient Quality of Life Secondary · 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.

QoL-AD Pre-Intervention

Group	Value	95% CI
Dementia Care Quality at Home	25.5	24.2 – 26.8

QoL-AD Post-Intervention

Group	Value	95% CI
Dementia Care Quality at Home	28.5	26.6 – 30.4

Heard and Understood Secondary · Post Intervention (6 months)

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

Group	Value	95% CI
Dementia Care Quality at Home	37

Caregivers - Net Promoter Score of Intervention Secondary · 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.

Group	Value	95% CI
Dementia Care Quality at Home	8.8	8.2 – 9.4

Feasibility for the Practice to Use Care Modules. Secondary · 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

Group	Value	95% CI
Dementia Care Quality at Home	18

Feasibility for the Practice to Complete Care Modules Secondary · Post Intervention (6-months)

Percent of audited modules that are completed.

Group	Value	95% CI
Dementia Care Quality at Home	11

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Caring for caregivers and persons living with dementia under home-based primary care: protocol for an interventional clinical trial.
   Sy M, Thacker A, Sheehan OC, Leff B, et al · · 2024 · cited 2× · PMID 38336779 · DOI 10.1186/s40814-024-01455-x
2. Feasibility and Acceptability of a Clinician-Caregiver Co-Designed Dementia Care Intervention for Home-Based Primary Care.
   Ritchie C, Leff B, Sy M, Thacker A, et al · · 2025 · cited 1× · PMID 40976934 · DOI 10.1111/jgs.70112