Trial Outcomes & Findings for Caring for Caregivers and People Living With Dementia Under Home-Based Primary Care (NCT NCT05849259)

NCT ID: NCT05849259

Last Updated: 2025-09-25

Results Overview

The percentage of identified caregivers who complete baseline assessments.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2025-09-25

Participant Flow

Participant milestones

Measure	Dementia Care Quality at Home Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Overall Study STARTED	50
Overall Study Caregivers Enrolled	50
Overall Study Practice Personnel Enrolled	21
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	11

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Dementia Care Quality at Home n=50 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	26 Participants n=5 Participants
Age, Categorical >=65 years	24 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 13 • n=5 Participants
Sex: Female, Male Female	39 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	12 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	50 participants n=5 Participants
Role of Caregiver Adult Child	27 Participants n=5 Participants
Role of Caregiver Facility Caregiver	9 Participants n=5 Participants
Role of Caregiver Spouse/Partner	7 Participants n=5 Participants
Role of Caregiver Niece	3 Participants n=5 Participants
Role of Caregiver Private Paid Caregiver	3 Participants n=5 Participants
Role of Caregiver Sibling	1 Participants n=5 Participants
Hours Spent Caregiving per week	88 hours per week STANDARD_DEVIATION 60 • n=5 Participants
Quality of Life in Alzheimer's Disease	26 units on a scale STANDARD_DEVIATION 5 • n=5 Participants
The Neuropsychiatric Inventory Questionnaire: Severity Score	10 units on a scale STANDARD_DEVIATION 7 • n=5 Participants
The Neuropsychiatric Inventory Questionnaire: Distress Score	14 units on a scale STANDARD_DEVIATION 12 • n=5 Participants
Zarit Burden Interview Score	16 units on a scale STANDARD_DEVIATION 11 • n=5 Participants
Patient Health Questionnaire 8 Item Score	5 units on a scale STANDARD_DEVIATION 4 • n=5 Participants
Care Ecosystem Caregiver Self-Efficacy Score	8 units on a scale STANDARD_DEVIATION 3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline

The percentage of identified caregivers who complete baseline assessments.

Outcome measures

Measure	Dementia Care Quality at Home n=50 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Caregiver to Engage With and Complete Baseline Assessments.	50 Participants

PRIMARY outcome

Timeframe: Post-intervention (6 months)

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

Outcome measures

Measure	Dementia Care Quality at Home n=50 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Caregiver to Access Educational Materials and Community Resources.	50 Participants

PRIMARY outcome

Timeframe: Baseline

Population: % of practice staff that "agree" or "strongly agree" that "it was easy for our practice to generate a list of persons living with dementia"

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

Outcome measures

Measure	Dementia Care Quality at Home n=21 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice of Identifying Potential Patients/Caregivers	18 Participants

PRIMARY outcome

Timeframe: Baseline

Population: % of practice staff that "agree" or "strongly agree" that "it was easy for our practice to generate a list of persons living with dementia"

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

Outcome measures

Measure	Dementia Care Quality at Home n=21 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice of Assessing Eligible Patient/Caregiver Dyads.	18 Participants

PRIMARY outcome

Timeframe: Post-intervention (6 months)

Population: \> 75% practice personnel who conduct assessments will "agree" or "strongly agree" that assessments were feasible to use

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

Outcome measures

Measure	Dementia Care Quality at Home n=21 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice to Use Baseline Assessments.	18 Participants

PRIMARY outcome

Timeframe: Post-intervention (6 months)

Population: 75% of audited assessments will be completed

The percent of audited assessments that are completed.

Outcome measures

Measure	Dementia Care Quality at Home n=10 assessments Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice to Complete Baseline Assessments	7 assessments

SECONDARY outcome

Timeframe: Pre-intervention

Population: The number of participants analyzed is greater than 50 as 80 is the number of dyads that were eligible for the study

Percentage of eligible dyads who enroll.

Outcome measures

Measure	Dementia Care Quality at Home n=80 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice of Recruiting Patient/Caregiver Dyads	50 Participants

SECONDARY outcome

Timeframe: Pre-Intervention (baseline) and post-intervention (6 months)

Population: Quality of Life in Alzheimer's Disease score Pre and Post-Intervention

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.

Outcome measures

Measure	Dementia Care Quality at Home n=50 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Patient Quality of Life QoL-AD Pre-Intervention	25.5 score on a scale Interval 24.2 to 26.8
Patient Quality of Life QoL-AD Post-Intervention	28.5 score on a scale Interval 26.6 to 30.4

SECONDARY outcome

Timeframe: Post Intervention (6 months)

Population: % of caregivers who report that they felt heard and understood "quite a bit" or "completely" by the practice

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

Outcome measures

Measure	Dementia Care Quality at Home n=39 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Heard and Understood	37 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Dementia Care Quality at Home n=39 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Caregivers - Net Promoter Score of Intervention	8.8 score on a scale Interval 8.2 to 9.4

SECONDARY outcome

Timeframe: Post-intervention (6 months)

Population: \> 75% practice personnel who complete the modules will rate the modules as "feasible" or "very feasible" to use \> 50% of audited modules will be completed

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

Outcome measures

Measure	Dementia Care Quality at Home n=21 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice to Use Care Modules.	18 Participants

SECONDARY outcome

Timeframe: Post Intervention (6-months)

Population: \> 50% of audited modules will be completed

Percent of audited modules that are completed.

Outcome measures

Measure	Dementia Care Quality at Home n=12 modules Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice to Complete Care Modules	11 modules

SECONDARY outcome

Timeframe: Post-intervention (6 months)

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

Outcome measures

Measure	Dementia Care Quality at Home n=25 case conferences attended Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice of Clinicians to Engage With the Tele-video Case Conference.	25 case conferences attended

SECONDARY outcome

Timeframe: Pre-intervention (baseline)

Population: The number of participants analyzed is greater than 50, as 80 is the number of dyads that were eligible for the study and invited to participate, 50 out of 80 enrolled.

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

Outcome measures

Measure	Dementia Care Quality at Home n=80 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Acceptability of the Intervention to Caregivers to Participate in the Intervention.	50 Participants

SECONDARY outcome

Timeframe: Pre-intervention (baseline)

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

Outcome measures

Measure	Dementia Care Quality at Home n=50 Participants Caregivers across two HBPC practices receive the Dementia Care Quality at Home intervention.
Feasibility for the Practice of Percent of Racial and Ethnic Minorities Recruited.	26 Participants

Adverse Events

Dementia Care Quality at Home Caregivers

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Dementia Care Quality at Home Practice Personnel

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine S Ritchie

Massachusetts General Hospital

Phone: 415-672-1780

Email: csritchie@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place