VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05622734
• Other study ID #: STUDY00015485
• Secondary ID: P30AG064200
• Status: Completed
• Phase: N/A
• Start date: April 21, 2023
• Est. completion date: December 30, 2023

Study information

• Verified date: May 2024
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: December 30, 2023
• Est. primary completion date: November 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregiver Burden
• Dementia
• Lewy Body Disease
• Skill, Coping
• Stress

Intervention

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.

Locations

Country	Name	City	State
United States	University of Washington School of Nursing	Seattle	Washington

Sponsors (3)

Lead Sponsor	Collaborator
University of Washington	Emory University, National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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