VOCALE LBD+ Leveraging Social Technologies and Problem-Solving Skills to Enhance Mastery Among Caregivers of Persons With Lewy Body Dementia
Phase: NA
Conditions: Caregiver Burden, Lewy Body Disease, Stress, Skill, Coping
Sponsor: University of Washington

VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia 
 
NCT05622734 
 
August 27th, 2024 
 
 

 
 
Study Design  
This study was a pilot quasi-experimental single-arm study to examine preliminary 
effects of the VOCALE LBD+ intervention.  Primary outcome measures were collected 
at the beginning and end of the eight-week intervention  
 
Recruitment and Participants 
Participants were primarily recruited from the Memory and Brain Wellness Center 
(MBWC) at Harborview Medical Center in Seattle, Washington. The MBWC evaluates 
over 1000 new patients annually and is the only major academic medical center in the 
five-state region of Washington, Wyoming, Alaska, Montana, and Idaho. Participants 
were also recruited through posted announcements on the websites and newsletters of 
community organizations such as Lewy Body Disease Association (LBDA) and 
Alzheimer.gov that serve the target population.  
 
To be eligible for participation, persons should be a family/informal caregiver of a person 
with a diagnosis of LBD; can read, write, and speak English; has a device that can 
access the Internet and be used for videoconferencing and/or phone calls; is 18 years 
or older.  
 
Primary Outcome 
Seven-item Pearlin Mastery Scale was used to measure mastery. On a scale of 1 to 4 
(with 1 being “strongly disagree” and 4 being “strongly agree”), the measure assessed 
how strongly do you agree or disagree. Items 1 through item 5 were reversed so scores 
range from 7 to 28 and higher scores indicate greater mastery.  
  
Analysis Plan 
Data were analyzed across time points using Cohen's d to quantify effect sizes, 
focusing on changes from baseline to the end of the intervention. To address potential 
data non-normality and provide robust estimates, we employed bootstrapping with 
1,000 resamples using the boot package in R to determine the 95% confidence intervals 
of the effect sizes.