Caregiver BurdenNCT05622734
VOCALE LBD+ for Caregivers of Persons With Lewy Body Dementia
A study testing VOCALE LBD+ in people with Caregiver Burden and Lewy Body Disease, run by University of Washington at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Caregiver Burden, Lewy Body Disease, Stress
- What is being tested?
- VOCALE LBD+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Apr 2023to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Washington School of Nursing
Seattle, Washington, 98195
About this study
Official title: 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.
- Conditions
- Caregiver Burden, Lewy Body Disease, Stress, Skill, Coping
- Being tested
- VOCALE LBD+
- Medical subject headings
- Caregiver Burden, Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VOCALE LBD+Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| VOCALE LBD+ | Experimental | Not described Receives: Behavioral: VOCALE LBD+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline; 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2022
- Study start21 Apr 2023
- Primary completion30 Nov 2023
- Study completion30 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Caregiver BurdenStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Emory University, National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Oleg Zaslavsky, University of Washington
- Investigators
- Oleg Zaslavsky, PhD, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05622734
- Sponsor's protocol ID
- STUDY00015485
- Other IDs
- P30AG064200
- Status last verified
- Aug 2024
- First submitted
- 9 Nov 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VOCALE LBD+ Leveraging Social Technologies and Problem-Solving Skills to Enhance Mastery Among Caregivers of Persons With Lewy Body Dementia
- ClinicalTrials.gov ID
- NCT05622734
- Acronym / sponsor ID
- STUDY00015485
- Conditions
- Caregiver Burden, Lewy Body Disease, Stress, Skill, Coping
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Emory University, National Institute on Aging (NIA)
- Study start
- 21 Apr 2023 (actual)
- Primary completion
- 30 Nov 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 21 Nov 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VOCALE LBD+ | Experimental | Behavioral: VOCALE LBD+ |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | VOCALE LBD+ |
Primary outcome
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oleg Zaslavsky, PhD principal investigator
University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VOCALE LBD+ in people with Caregiver Burden and Lewy Body Disease, run by University of Washington at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect Size of Change From Baseline Caregiving Mastery at 4 Weeks (time frame: Baseline; 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.