VOCALE LBD+ for 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.

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Key information

Conditions

Caregiver Burden Basal Ganglia Diseases Behavior Behavioral Symptoms Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Skill, Coping Stress Stress, Psychological Synucleinopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington School of Nursing

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

Effect Size of Change From Baseline Caregiving Mastery at 4 Weeks

Time frame: Baseline; 4 weeks

Change in Pearlin's Caregiver Competence Scale Over Time, scale ranges from 7 to 35 with lower score indicating better mastery

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

Emory University
National Institute on Aging (NIA)

Registry information

Official study title

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

Important dates

Study start: 2023
Primary completion: 2023
Study completion: 2023
First posted: Nov 21, 2022
Registry last updated: Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed