VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia

NCT05622734 | Completed Results DMC

• 2 other identifiers: STUDY00015485P30AG064200
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregiver Burden; Lewy Body Disease; Stress; Skill, Coping

Outcome Measures

Primary Outcomes (1)

• 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

  Baseline; 4 weeks

Study Arms (1)

VOCALE LBD+

EXPERIMENTAL

Behavioral: VOCALE LBD+

Interventions

VOCALE LBD+ BEHAVIORAL

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.

VOCALE LBD+

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• years or older

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• Emory University: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Washington School of Nursing

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Caregiver Burden; Lewy Body Disease

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Dementia; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Oleg Zaslavsky
• Organization: University of Washington School of Nursing

ozasl@uw.edu

2068493301

Study Officials

• Oleg Zaslavsky, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Nursing

Study Record Dates

• First Submitted: November 9, 2022
• First Posted: November 21, 2022
• Study Start: April 21, 2023
• Primary Completion: November 30, 2023
• Study Completion: December 30, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)