Trial Outcomes & Findings for VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia (NCT NCT05622734)
NCT ID: NCT05622734
Last Updated: 2024-09-19
Results Overview
Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
39 participants
Primary outcome timeframe
Baseline; 4 weeks
Results posted on
2024-09-19
Participant Flow
Participant milestones
| Measure |
VOCALE LBD+
VOCALE LBD+: Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.
|
|---|---|
|
Overall Study
STARTED
|
39
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia
Baseline characteristics by cohort
| Measure |
VOCALE LBD+
n=39 Participants
VOCALE LBD+: Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.
|
|---|---|
|
Age, Continuous
|
67.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
37 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Spouse/partner
|
34 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline; 4 weeksChange in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery
Outcome measures
| Measure |
VOCALE LBD+
n=32 Participants
VOCALE LBD+: Intervention employs a web-based platform that allows participants to engage asynchronously in an eight-week online intervention involving didactic training, peer-to-peer support, and moderated problem-solving skill enactment.
|
|---|---|
|
Effect Size of Change From Baseline Caregiving Mastery at 4 Weeks
|
-0.04 score on a scale
Interval -0.36 to 0.29
|
Adverse Events
VOCALE LBD+
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
Oleg Zaslavsky
University of Washington School of Nursing
Phone: 2068493301
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place