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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
No Placebo-Only Group
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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change outcome measure at 12 months and 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change outcome measure at 12 months and 18 months
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 moreSecondary 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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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.
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Who is running the clinical trial?
University of VirginiaLead Sponsor
782 Previous Clinical Trials
1,315,554 Total Patients Enrolled
1 Trials studying Dementia
24 Patients Enrolled for Dementia
Congressionally Directed Medical Research ProgramsFED
54 Previous Clinical Trials
9,450 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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Caregiver PWD-ADRD TCCI
- Group 2: Caregiver for PWD-TBI TCCI
- Group 3: Caregiver for PWD-TBI (BMT)
- Group 4: Caregiver for PWD-ADRD (BMT)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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