Back to resultsVOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia
Primary Purpose
Caregiver Burden, Lewy Body Disease, Stress
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VOCALE LBD+
Sponsored by
About this trial
This is an interventional supportive care trial for Caregiver Burden
Eligibility Criteria
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
Sites / Locations
- University of Washington School of NursingRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
VOCALE LBD+
Arm Description
Outcomes
Primary Outcome Measures
A Change From Baseline Caregiving Mastery at 4 and 8 weeks
Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery
Secondary Outcome Measures
Full Information
NCT ID
NCT05622734
First Posted
November 9, 2022
Last Updated
April 21, 2023
Sponsor
University of Washington
Collaborators
Emory University, National Institute on Aging (NIA)
1. Study Identification
Unique Protocol Identification Number
NCT05622734
Brief Title
VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia
Official Title
VOCALE LBD+ Leveraging Social Technologies and Problem-Solving Skills to Enhance Mastery Among Caregivers of Persons With Lewy Body Dementia
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 21, 2023 (Actual)
Primary Completion Date
December 10, 2023 (Anticipated)
Study Completion Date
December 11, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
Emory University, National Institute on Aging (NIA)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregiver Burden, Lewy Body Disease, Stress, Skill, Coping
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
41 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
VOCALE LBD+
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
VOCALE LBD+
Intervention Description
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.
Primary Outcome Measure Information:
Title
A Change From Baseline Caregiving Mastery at 4 and 8 weeks
Description
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, 8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Annie Chen, PhD
Phone
206 221-9218
Email
atchen@uw.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Oleg Zaslavsky, PhD
Phone
206-849-3301
Email
ozasl@uw.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Oleg Zaslavsky, PhD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Washington School of Nursing
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jasmine Kaneshiro, DNP
Email
jkanesh1@uw.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia
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