VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia

VOCALE LBD+ Leveraging Social Technologies and Problem-Solving Skills to Enhance Mastery Among Caregivers of Persons With Lewy Body Dementia

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.

Study Overview

• Status: Recruiting
• Conditions: Stress; Caregiver Burden; Lewy Body Disease; Skill, Coping
• Intervention / Treatment: Behavioral: VOCALE LBD+

• Study Type: Interventional
• Enrollment (Anticipated): 41
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Annie Chen, PhD; Phone Number: 206 221-9218; Email: atchen@uw.edu
• Study Contact Backup: Name: Oleg Zaslavsky, PhD; Phone Number: 206-849-3301; Email: ozasl@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington School of Nursing
      • Contact: Jasmine Kaneshiro, DNP; Email: jkanesh1@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: VOCALE LBD+	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Baseline; 4 weeks, 8 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Collaborators: Emory University; National Institute on Aging (NIA)
• Investigators: Principal Investigator: Oleg Zaslavsky, PhD, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2023
• Primary Completion (Anticipated): December 10, 2023
• Study Completion (Anticipated): December 11, 2023

Study Registration Dates

• First Submitted: November 9, 2022
• First Submitted That Met QC Criteria: November 16, 2022
• First Posted (Actual): November 21, 2022

Study Record Updates

• Last Update Posted (Actual): April 25, 2023
• Last Update Submitted That Met QC Criteria: April 21, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Stress, Psychological; Dementia; Lewy Body Disease; Caregiver Burden
• Other Study ID Numbers: STUDY00015485; P30AG064200 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No