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Telehealth Support for Dementia and Brain Injury Caregivers

N/A
Waitlist Available
Led By Carol Manning, Ph.D.
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must be at least 18 years of age
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change outcome measure at 12 months and 18 months
Awards & highlights

Summary

This trial will study the benefits of telehealth for caregivers of people with Alzheimer's disease or dementia related to a traumatic brain injury.

Who is the study for?
This trial is for unpaid caregivers over 18 years old who are the primary caregiver for someone with dementia living in the community. They must have basic English skills. It's not specified who can't join, but typically those not meeting these criteria would be excluded.
What is being tested?
The study tests a telehealth-delivered care coordination program to support caregivers of individuals with Alzheimer's and TBI-related dementia. Caregivers will use devices like phones or computers to access this program for a year.
What are the potential side effects?
Since this trial involves a non-medical intervention (telehealth support), traditional side effects associated with medications are not expected. However, participants may experience changes in stress levels or emotional state.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change outcome measure at 12 months and 18 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and change outcome measure at 12 months and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Caregiver Burden: Zarit Burden Interview (ZBI)
Caregiver Reactions to the Behavioral Symptoms of Dementia: Revised Memory and Behavior Problem Checklist (RMBPC)
Depression: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
+2 more
Secondary study objectives
Anxiety: Geriatric Anxiety Inventory (GAI).
Basic Activities of Daily Living: Katz Index of Independence in Activities of Daily Living (Katz).
Dementia Knowledge: Dementia Knowledge Assessment Tool Version 2 (DKAT2).
+7 more

Trial Design

4Treatment groups
Experimental Treatment
Active Control
Group I: Caregiver for PWD-TBI TCCIExperimental Treatment1 Intervention
Participants in the Caregiver PWD-TBI telehealth care coordination intervention (TCCI) group will complete a 12-month telehealth-delivered care coordination program with an assigned dementia care coordinator.
Group II: Caregiver PWD-ADRD TCCIExperimental Treatment1 Intervention
Participants in the Caregiver PWD-ADRD telehealth care coordination intervention (TCCI) group will complete a 12-month telehealth-delivered care coordination program with an assigned dementia care coordinator.
Group III: Caregiver for PWD-TBI (BMT)Active Control1 Intervention
Participants in the Caregiver PWD-TBI best medical treatment (BMT) group will not receive care coordination.
Group IV: Caregiver for PWD-ADRD (BMT)Active Control1 Intervention
Participants in the Caregiver PWD-ADRD best medical treatment (BMT) group will not receive care coordination.

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor
771 Previous Clinical Trials
1,284,126 Total Patients Enrolled
1 Trials studying Dementia
24 Patients Enrolled for Dementia
Congressionally Directed Medical Research ProgramsFED
54 Previous Clinical Trials
9,440 Total Patients Enrolled
Carol Manning, Ph.D.4.917 ReviewsPrincipal Investigator - University of Virginia Department of Neurology
Inova Alexandria Hospital, Calvert Memorial Hospital
Medical School - Howard University, Doctor of Medicine
Howard University, Residency in Orthopedic Surgery
5Patient Review
Dr. Carpenter was attentive and easy to talk to.

Media Library

Telehealth-delivered Care Coordination Program Clinical Trial Eligibility Overview. Trial Name: NCT04495686 — N/A
Dementia Research Study Groups: Caregiver PWD-ADRD TCCI, Caregiver for PWD-TBI TCCI, Caregiver for PWD-TBI (BMT), Caregiver for PWD-ADRD (BMT)
Dementia Clinical Trial 2023: Telehealth-delivered Care Coordination Program Highlights & Side Effects. Trial Name: NCT04495686 — N/A
Telehealth-delivered Care Coordination Program 2023 Treatment Timeline for Medical Study. Trial Name: NCT04495686 — N/A
~35 spots leftby Sep 2025
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