Trial Outcomes & Findings for Primary Care-based Study of an Online Workshop for Family Caregivers of PLWD (NCT NCT06928467)

NCT ID: NCT06928467

Last Updated: 2026-07-16

Results Overview

Percentage of enrolled caregivers who complete caregiver depressive symptoms survey questions from the 8-item Patient Health Questionnaire (PHQ-8), with score range 0-24 (higher score indicates worse depressive symptoms), with range 0% to 100% (higher percentage indicates higher completion rate).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

Up to 4 months

Results posted on

2026-07-16

Participant Flow

First, persons living with dementia that receive care from participating primary care clinics are identified from the EHR. Second, eligible caregivers are identified who are listed as primary contacts and also receive healthcare at either study site. Eligible caregivers were sent information letters about a workshop via EHR-linked MyChart message or USPS mail. Information letters indicates that interested caregivers can learn more sign up for the workshop program by going to an online website.

The number enrolled reflects the number of caregiver-and-persons-living-with-dementia dyads, while the number started reflects the total number of unique participants. When eligible caregivers signed up, they were told it would start in 1-4 months. When a workshop start date was confirmed, caregivers completed the baseline PHQ-8 and were enrolled and randomized. The workshop group received instructions on registration.

Participant milestones

Participant milestones
Measure
Workshop - Caregivers
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia.
Control - Caregivers
Wait-list control group.
Workshop - Persons Living With Dementia
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia.
Control - Persons Living With Dementia
Wait-list control group.
Overall Study
STARTED
82
27
82
27
Overall Study
COMPLETED
60
18
82
27
Overall Study
NOT COMPLETED
22
9
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

109 total dyads (caregivers and their person living with dementia)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Workshop
n=164 Participants
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia. Building Better Caregivers workshop: The BBC workshop is a 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia or other form of cognitive impairment. It is an evidence-based workshop of the Self-Management Resource Center originally developed at Stanford University for the Veterans Administration and is now licensed for online delivery by Canary Health. Content focuses on increasing participant self-management behaviors, dementia caregiving skills, and peer social support. The workshop uses a peer-facilitated small group format with frequent online interactions between approximately 27 participants on threaded discussion boards. Activities are guided by two trained peer co-facilitators (caregivers themselves). Each week focuses on 2-3 new topics and tools for participants to learn and use. In threaded discussion board conversations participants interact, help each other, and provide peer social support.
Control
n=54 Participants
Wait-list control group.
Total
n=218 Participants
Total of all reporting groups
Age, Continuous
Caregivers
69.1 years
STANDARD_DEVIATION 11.9 • n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
65.4 years
STANDARD_DEVIATION 12.1 • n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
68.2 years
STANDARD_DEVIATION 12.0 • n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Age, Continuous
Persons living with dementia
82.2 years
STANDARD_DEVIATION 8.8 • n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
79.7 years
STANDARD_DEVIATION 10.8 • n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
81.6 years
STANDARD_DEVIATION 9.3 • n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Sex: Female, Male
Caregivers · Female
60 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
20 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
80 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Sex: Female, Male
Caregivers · Male
22 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
7 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
29 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Sex: Female, Male
Persons living with dementia · Female
41 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
15 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
56 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Sex: Female, Male
Persons living with dementia · Male
41 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
12 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
53 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Ethnicity (NIH/OMB)
Caregivers · Hispanic or Latino
7 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
2 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
9 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Ethnicity (NIH/OMB)
Caregivers · Not Hispanic or Latino
70 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
24 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
94 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Ethnicity (NIH/OMB)
Caregivers · Unknown or Not Reported
5 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
1 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
6 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Ethnicity (NIH/OMB)
Persons living with dementia · Hispanic or Latino
5 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
1 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
6 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Ethnicity (NIH/OMB)
Persons living with dementia · Not Hispanic or Latino
72 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
22 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
94 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Ethnicity (NIH/OMB)
Persons living with dementia · Unknown or Not Reported
5 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
4 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
9 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Caregivers · American Indian or Alaska Native
0 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
0 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
0 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Caregivers · Asian
14 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
8 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
22 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Caregivers · Native Hawaiian or Other Pacific Islander
1 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
0 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
1 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Caregivers · Black or African American
4 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
1 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
5 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Caregivers · White
58 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
16 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
74 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Caregivers · More than one race
5 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
1 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
6 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Caregivers · Unknown or Not Reported
0 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
1 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
1 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Persons living with dementia · American Indian or Alaska Native
0 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
0 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
0 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Persons living with dementia · Asian
12 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
5 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
17 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Persons living with dementia · Native Hawaiian or Other Pacific Islander
0 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
0 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
0 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Persons living with dementia · Black or African American
3 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
2 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
5 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Persons living with dementia · White
61 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
16 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
77 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Persons living with dementia · More than one race
6 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
2 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
8 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)
Race (NIH/OMB)
Persons living with dementia · Unknown or Not Reported
0 Participants
n=82 Participants • 109 total dyads (caregivers and their person living with dementia)
2 Participants
n=27 Participants • 109 total dyads (caregivers and their person living with dementia)
2 Participants
n=109 Participants • 109 total dyads (caregivers and their person living with dementia)

PRIMARY outcome

Timeframe: Up to 4 months

Population: Caregivers

Percentage of enrolled caregivers who complete caregiver depressive symptoms survey questions from the 8-item Patient Health Questionnaire (PHQ-8), with score range 0-24 (higher score indicates worse depressive symptoms), with range 0% to 100% (higher percentage indicates higher completion rate).

Outcome measures

Outcome measures
Measure
Workshop
n=82 Participants
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia.
Control
n=27 Participants
Wait-list control group.
3a. Percent of Enrolled Caregivers Who Complete Caregiver Depressive Symptoms (PHQ-8) Survey Questions
56 Participants
22 Participants

SECONDARY outcome

Timeframe: Up to 5.5 months

Population: Persons living with dementia

Aggregate healthcare utilization days across all participants by group measured as emergency room and hospitalization days of use among persons living with dementia who are care partners of enrolled caregivers during the 3-month post-group delivery period, with range 0-90 days (higher count indicates more days). The total number of days is reported.

Outcome measures

Outcome measures
Measure
Workshop
n=82 Participants
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia.
Control
n=27 Participants
Wait-list control group.
3b. Healthcare Utilization of Emergency Room Visits and Hospitalizations by Person Living With Dementia
66 days
19 days

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Percentage of invitation letters that are unread, with unread defined as being unopened electronic messages in the electronic health record or returned paper letters returned by US postal service), with range 0% to 100% (higher percentage indicates higher unread rate).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline

Among caregivers for whom contact is attempted by invitation letter, the percentage of caregivers who enroll, with range 0% to 100% (higher percentage indicates higher enrollment rate).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 weeks

Among caregivers who are assigned to workshop, the percentage of caregivers who complete the workshop, with range 0% to 100% (higher percentage indicates higher completion rate).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 4 months

Among caregivers who are assigned to workshop, the percentage of caregivers who report the workshop to be acceptable using a likelihood to recommend 10-point Likert scale, with range 0 to 10 and scale anchors at each end, with 0 anchored by "not at all likely" and 10 anchored by "extremely likely" (higher score indicates higher acceptability).

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 6 weeks

Among workshops, percentage of delivery weeks that meet all elements of fidelity checklist for that week, with range 0% to 100% (higher percentage indicates greater delivery fidelity).

Outcome measures

Outcome data not reported

Adverse Events

Workshop - Caregivers

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Control - Caregivers

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Workshop - Persons Living With Dementia

Serious events: 2 serious events
Other events: 0 other events
Deaths: 2 deaths

Control - Persons Living With Dementia

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Workshop - Caregivers
n=82 participants at risk
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia. Building Better Caregivers workshop: The BBC workshop is a 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia or other form of cognitive impairment. It is an evidence-based workshop of the Self-Management Resource Center originally developed at Stanford University for the Veterans Administration and is now licensed for online delivery by Canary Health. Content focuses on increasing participant self-management behaviors, dementia caregiving skills, and peer social support. The workshop uses a peer-facilitated small group format with frequent online interactions between approximately 27 participants on threaded discussion boards. Activities are guided by two trained peer co-facilitators (caregivers themselves). Each week focuses on 2-3 new topics and tools for participants to learn and use. In threaded discussion board conversations participants interact, help each other, and provide peer social support.
Control - Caregivers
n=27 participants at risk
Wait-list control group.
Workshop - Persons Living With Dementia
n=82 participants at risk
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia. Building Better Caregivers workshop: The BBC workshop is a 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia or other form of cognitive impairment. It is an evidence-based workshop of the Self-Management Resource Center originally developed at Stanford University for the Veterans Administration and is now licensed for online delivery by Canary Health. Content focuses on increasing participant self-management behaviors, dementia caregiving skills, and peer social support. The workshop uses a peer-facilitated small group format with frequent online interactions between approximately 27 participants on threaded discussion boards. Activities are guided by two trained peer co-facilitators (caregivers themselves). Each week focuses on 2-3 new topics and tools for participants to learn and use. In threaded discussion board conversations participants interact, help each other, and provide peer social support.
Control - Persons Living With Dementia
n=27 participants at risk
Wait-list control group.
Cardiac disorders
Death due to cardiac disorder
0.00%
0/82 • Caregivers - 4 months; persons living with dementia - 6 months
0.00%
0/27 • Caregivers - 4 months; persons living with dementia - 6 months
2.4%
2/82 • Caregivers - 4 months; persons living with dementia - 6 months
0.00%
0/27 • Caregivers - 4 months; persons living with dementia - 6 months

Other adverse events

Other adverse events
Measure
Workshop - Caregivers
n=82 participants at risk
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia. Building Better Caregivers workshop: The BBC workshop is a 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia or other form of cognitive impairment. It is an evidence-based workshop of the Self-Management Resource Center originally developed at Stanford University for the Veterans Administration and is now licensed for online delivery by Canary Health. Content focuses on increasing participant self-management behaviors, dementia caregiving skills, and peer social support. The workshop uses a peer-facilitated small group format with frequent online interactions between approximately 27 participants on threaded discussion boards. Activities are guided by two trained peer co-facilitators (caregivers themselves). Each week focuses on 2-3 new topics and tools for participants to learn and use. In threaded discussion board conversations participants interact, help each other, and provide peer social support.
Control - Caregivers
n=27 participants at risk
Wait-list control group.
Workshop - Persons Living With Dementia
n=82 participants at risk
A 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia. Building Better Caregivers workshop: The BBC workshop is a 6-week, online, peer-led small group workshop designed for family caregivers of persons living with dementia or other form of cognitive impairment. It is an evidence-based workshop of the Self-Management Resource Center originally developed at Stanford University for the Veterans Administration and is now licensed for online delivery by Canary Health. Content focuses on increasing participant self-management behaviors, dementia caregiving skills, and peer social support. The workshop uses a peer-facilitated small group format with frequent online interactions between approximately 27 participants on threaded discussion boards. Activities are guided by two trained peer co-facilitators (caregivers themselves). Each week focuses on 2-3 new topics and tools for participants to learn and use. In threaded discussion board conversations participants interact, help each other, and provide peer social support.
Control - Persons Living With Dementia
n=27 participants at risk
Wait-list control group.
Psychiatric disorders
High depressive symptoms score on PHQ-8
1.2%
1/82 • Caregivers - 4 months; persons living with dementia - 6 months
0.00%
0/27 • Caregivers - 4 months; persons living with dementia - 6 months
0.00%
0/82 • Caregivers - 4 months; persons living with dementia - 6 months
0.00%
0/27 • Caregivers - 4 months; persons living with dementia - 6 months

Additional Information

Veronica Yank, MD

University of California San Francisco

Phone: 415-476-9654

Results disclosure agreements

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