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

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

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 weeks

Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery

Outcome measures

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

Results disclosure agreements

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