CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 67 enrolled
Drug / intervention
STAR-C-VTF +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04271046
NCT04271046N/ACompleted

STAR Caregivers - Virtual Training and Follow-up

Kaiser Permanente·interventional·Posted Feb 17, 2020·Updated Feb 4, 2025

In Brief

A clinical study evaluating STAR-C-VTF and Control for Alzheimer Disease and 2 related conditions. Completed, enrolled 67 participants across 1 site.

Detailed Summary

This study evaluates the effectiveness of a caregiver outreach, training, and support program for caregivers of people with dementia who are using antipsychotic medication to manage agitation/aggression. The Investigators will conduct a randomized trial of the caregiver program compared to a control group to measure differences in caregiver burden and discontinuation of antipsychotic medication use. The results will help in expanding access to and delivery of empirically supported behavioral health services for caregivers and people with dementia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 17, 2020
Enrollment StartMay 1, 2020
Primary CompletionSep 1, 2023
Study CompletionSep 21, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 6.4 years ago

Interventions

STAR-C-VTFbehavioral

1. One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study and to acquaint the caregiver with the STAR-VTF components of good dementia care; distribute printed educational material (and links to same material online); 2. Six 30-minute follow-up phone calls with the caregiver following each of the 6 learning modules to review STAR-VTF concepts, and further brainstorm strategies to modify identified activators and consequences with the objective of reducing behavioral symptoms; 3. secure message support, as needed, with the coach to help with personalizing the STAR-VTF curriculum for up to 6 months.

Controlbehavioral

One 60 minute baseline orientation phone visit with a coach to get verbal consent for participation in the study. Controls will receive usual care from their primary care provider and/or psychiatrist. We will give participants an information package from the Alzheimer's Association including a list of resources. To assist with retention, and to measure responses to secure messages, we will send a template secure message to control dyads once per month in which we remind participants to contact their primary care provider if they have any issues with behavioral and psychological symptoms of dementia. Dyads in the attention control may receive information and training from their primary care provider and the Alzheimer's Association. This "attention control" is proposed to assess the additional impact of STAR-VTF above treatment as usual. Investigators do not intend to track non-study training receipt in the control arm.