Caregiver Burden, Lewy Body Disease, Skill, Coping, Stress
Conditions
Brief summary
The goal of this clinical trial is to evaluate the feasibility, acceptability, and initial efficacy of the VOCALE LBD+ intervention in caregivers of persons living with Lewy Body Dementia. The main question\[s\] it aims to answer are: * What is the extent to which the VOCALE LBD+ intervention affects caregiving mastery scores at the end of the eight-week intervention * What is the extent to which a change in caregiving mastery scores is retained four weeks after the end of the VOCALE LBD+ intervention Participants will be asked to participate in a fully online asynchronous VOCALE LBD+ intervention that involves a moderated web-based discussion platform, peer-to-peer support, didactic training, and problem-solving skill enactment.
Interventions
BEHAVIORALVOCALE 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.
Sponsors
Emory University
National Institute on Aging (NIA)
University of Washington
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Informal and/or lay caregiver of a patient with LBD * Can read, write, and speak English * Has access to a device that can be used for videoconferencing and/or phone calls * 18 years or older
Exclusion criteria
* Not an informal and/or lay caregiver * Cannot read and write in English * No access to a device that can be used for videoconferencing and/or phone calls Younger than 18 years old
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect Size of Change From Baseline Caregiving Mastery at 4 Weeks | Baseline; 4 weeks | Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 39 |
| Total | 39 |
Baseline characteristics
| Characteristic | VOCALE LBD+ |
|---|---|
| Age, Continuous | 67.6 years STANDARD_DEVIATION 9.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 37 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 12 Participants |
| Spouse/partner | 34 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 39 |
| other Total, other adverse events | 0 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Effect Size of Change From Baseline Caregiving Mastery at 4 Weeks
Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery
Time frame: Baseline; 4 weeks
| Arm | Measure | Value (MEAN) |
|---|---|---|
| VOCALE LBD+ | Effect Size of Change From Baseline Caregiving Mastery at 4 Weeks | -0.04 score on a scale |