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STAR-C-VTF for Dementia (STAR-C-VTF Trial)

N/A

Waitlist Available

Research Sponsored by Kaiser Permanente

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Investigators will identify and recruit Person with Dementia-Caregiver dyads in which the person with dementia has has made a healthcare visit in the last week where a diagnosis of Alzheimer's Disease or related dementia was recorded. Because we will enroll dyads, there are inclusion/

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 week and 6 month follow up

Awards & highlights

STAR-C-VTF Trial Summary

This trial will help researchers understand if a caregiver outreach program can help reduce caregiver burden and the use of antipsychotic medication for people with dementia.

Eligible Conditions

Dementia
Caregiver Burnout
Alzheimer's Disease

STAR-C-VTF Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

STAR-C-VTF Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 week and 6 month follow up

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 week and 6 month follow up

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 week and 6 month follow up for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Caregiver Burden

Use of antipsychotic medications

Secondary outcome measures

Change in Caregiver depression

Change in Caregiver self-efficacy

Other outcome measures

Number of Dyads Who Complete Training

Number of Emergency Department Visits

Number of Primary Care Visits

+5 more

STAR-C-VTF Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental Group- STAR-C-VTFExperimental Treatment1 Intervention

This study will use a parallel, two-arm randomized trial design. Participants will be 100 Person-with-Dementia-Caregiver dyads in which the person with dementia lives at home and recently filled a new prescription for antipsychotic medication. The experimental intervention will combine three elements: self-directed learning in which the caregiver will receive training materials delivered electronically through a web-based learning portal; one orientation phone visit with a coach; ongoing support from the coach via telephone and secure messaging in the web-portal. Participants will complete self-report assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment. Automated medication and primary care utilization data will be collected throughout the 6 month study period.

Group II: ControlActive Control1 Intervention

One orientation phone visit with a coach. Participants in the control condition will receive mailed material from the Alzheimer's Association, web links and template secure messages. Participants will complete self-report assessments at baseline, 8-weeks post-enrollment, and 6 months post-enrollment. Automated medication and primary care utilization data will be collected throughout the 6 month study period.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

STAR-C-VTF

2020

N/A

~70

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

National Institute on Aging (NIA)NIH

1,665 Previous Clinical Trials

28,005,012 Total Patients Enrolled

265 Trials studying Dementia

23,623,344 Patients Enrolled for Dementia

University of WashingtonOTHER

1,737 Previous Clinical Trials

1,843,394 Total Patients Enrolled

19 Trials studying Dementia

6,796 Patients Enrolled for Dementia

Kaiser PermanenteLead Sponsor

537 Previous Clinical Trials

24,113,632 Total Patients Enrolled

10 Trials studying Dementia

197,784 Patients Enrolled for Dementia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies left in this clinical trial?

"The clinicaltrials.gov website indicates that this medical trial, initially posted on September 1st 2020 and most recently updated October 17th 2021, is not presently seeking new patients. Nonetheless, 834 other trials are recruiting participants at the moment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

STAR Caregivers - Virtual Training and Follow-up

2020. "STAR Caregivers - Virtual Training and Follow-up". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04271046.