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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

Study 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.Check my eligibility

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.See study design

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 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

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

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

Primary outcome measures

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 outcome measures

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.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of VirginiaLead Sponsor

754 Previous Clinical Trials

1,244,902 Total Patients Enrolled

1 Trials studying Dementia

24 Patients Enrolled for Dementia

Congressionally Directed Medical Research ProgramsFED

47 Previous Clinical Trials

6,407 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

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 experiment that patients may fill?

"Clinicaltrials.gov does not indicate that this experiment is presently recruiting participants, as it was last updated on October 11th 2022 following its initial posting on March 3rd 2021. Nevertheless, other trials are actively enrolling and currently 1660 studies have open recruitment status."

Answered by AI

What are the fundamental aims of this research initiative?

"This study is designed to evaluate the Caregiver Burden of participants using the Zarit Burden Interview (ZBI) as a Change outcome measure at Baseline and 12 months and 18 months. Secondary outcomes include Optimism/Pessimism measured by Life-Orientation Test-Revised (LOT-R), Anxiety evaluated with Geriatric Anxiety Inventory (GAI), and Dementia Knowledge assessed through Dementia Knowledge Assessment Tool Version 2 (DKAT2)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury

Carol Manning 2021. "An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04495686.

All > Alzheimer Disease > Traumatic Brain Injury