An Innovative Supportive Care Model for Dementia and Traumatic Brain Injury
1 other identifier
interventional
171
1 country
1
Brief Summary
There are an increasing number of people in the U.S. with Alzheimer's disease and other dementias. Traumatic brain injuries (TBIs) are also common among both civilians and military personnel, and TBIs increase a person's risk for dementia. Providing care for a person with dementia is stressful. Dementia caregivers can experience difficulties including stress, depression, and reduced quality of life. Coordinated dementia care is known to benefit people with dementia and their caregivers. However, many caregivers do not have access to these supportive programs. Our project studies the benefits of telehealth as a new way for caregivers to receive coordinated dementia care services. We will offer 75 caregivers a 12-month caregiver support program delivered using telehealth (for example phones, tablets, computers). Caregivers of both Alzheimer's disease and TBI-related dementia will be included, and the program will be evaluated for effectiveness in both groups as well as in a control group. The information from our study will help improve quality of life for caregivers and individuals with dementia, including military members and Veterans. Our results will also help both civilian and military health professionals develop effective programs to support families living with dementia. Policy makers and organizational leaders can use the information to fund programs that best help families and communities facing dementia and TBI dementia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 18, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedStudy Start
First participant enrolled
March 3, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2025
CompletedNovember 29, 2023
November 1, 2023
4.5 years
May 18, 2020
November 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Depression: Center for Epidemiologic Studies Depression Scale - Revised (CESD-R)
The CESD-R assesses self-reported symptoms of depression. The revised version was developed to reflect current understanding of psychiatric depressive symptoms. The revised 20-item version is highly correlated with the original CESD, demonstrating test validity.
Change outcome measure at Baseline and 12 months and 18 months
Caregiver Burden: Zarit Burden Interview (ZBI)
The ZBI is a 22-item caregiver self-report measure assessing degree of caregiver burden in caregivers of PWD. The validated ZBI questions include measures of caregivers' health, finances, social supports, and psychological well-being.
Change outcome measure at Baseline and 12 months and 18 months
Caregiver Reactions to the Behavioral Symptoms of Dementia: Revised Memory and Behavior Problem Checklist (RMBPC)
The RMBPC is a 24-item, caregiver-reported measure that assesses the frequency of problematic behaviors in patients with dementia and the severity of caregivers' reactions to these behaviors. The reliability and validity of the RMBPC have been established.
Change outcome measure at Baseline and 12 months and 18 months
Quality of Life: WHO (Five) Well-Being Index (WHO-5)
The WHO-5 contains five questions that measure well-being; scores range from 0-25, with higher scores representing higher QoL. The WHO-5 is a validated tool that has been used successfully as an outcome measure in clinical trials across a wide range of study fields.
Change outcome measure at Baseline and 12 months and 18 months
Satisfaction with Care: Caregiver Satisfaction Survey (CSS)
The CSS is an investigator-developed survey that assesses satisfaction with care services.
Change outcome measure at 12 months and 18 months
Secondary Outcomes (10)
Healthcare Resource Utilization: Resource Utilization in Dementia, (RUD) questionnaire version 4.0.
Baseline, 12 months
Neuropsychiatric Symptoms and Caregiver Reactions: Neuropsychiatric Inventory Questionnaire (NPI-Q).
Baseline, 12 months
Anxiety: Geriatric Anxiety Inventory (GAI).
Baseline, 12 months
Dementia Knowledge: Dementia Knowledge Assessment Tool Version 2 (DKAT2).
Baseline, 12 months
Preparedness for Caregiving: Preparedness for Caregiving Scale (PCS).
Baseline, 12 months
- +5 more secondary outcomes
Study Arms (4)
Caregiver PWD-ADRD TCCI
EXPERIMENTALParticipants 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.
Caregiver for PWD-ADRD (BMT)
NO INTERVENTIONParticipants in the Caregiver PWD-ADRD best medical treatment (BMT) group will not receive care coordination.
Caregiver for PWD-TBI TCCI
EXPERIMENTALParticipants 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.
Caregiver for PWD-TBI (BMT)
NO INTERVENTIONParticipants in the Caregiver PWD-TBI best medical treatment (BMT) group will not receive care coordination.
Interventions
Participants in the interventional arms of this program will be assigned a Dementia Care Manager (DCM) who will work with caregivers to develop goals and plans that are aimed at providing the best support possible, specific to your needs. These services include supportive counseling, education on dementia, information and referrals to community-based organizations, behavioral symptom management training and assistance with finding available community and government-sponsored programs. DCM's will meet with you at least once monthly and will be available if you need assistance between meetings. At the first meeting, your DCM will explain the questionnaires you will take and how to use the technology in the program. They will then provide a link, via email, where you will download the free teleconferencing software that will be used throughout the program. Questionnaires will then be sent via email invitations through a secure survey platform.
Eligibility Criteria
You may qualify if:
- Must be at least 18 years of age
- Self-identified primary caregiver for a community-dwelling patient with dementia (PWD)
- Must be an unpaid caregiver
- Basic spoken and written English language skills
You may not qualify if:
- Unwilling or unable to fulfill the requirements of the study
- Any condition which would make the caregiver, in the opinion of the investigator, unsuitable for the study
- No access to high-speed/broadband internet service capable of operating study teleconferencing software available
- aged 55 years or older
- Diagnosis of mild cognitive impairment (MCI) or Alzheimer's disease and related dementias (ADRD)
- Mild to moderate dementia, including mixed dementia
- appointments in the multi-disciplinary long-term University of Virginia (UVA) Memory Disorder follow-up clinic (MDC)
- aged 21 years or older
- Diagnosis of major neurocognitive disorder (MND), mild neurocognitive disorder, or Alzheimer's disease and related dementias (ADRD)
- Diagnosis of mild to moderate dementia, including mixed dementia
- Diagnosed with mild complicated, moderate or sever traumatic brain injury (TBI)
- TBI event at or after the age of brain maturity, ≥25 years of age
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Virginia
Charlottesville, Virginia, 22908, United States
Related Publications (3)
Gallagher VT, Reilly SE, Arp A, Rossetti A, Thompson R, Manning CA. Randomized clinical trial of the individualized coordination and empowerment for care partners of persons with dementia (ICECaP) intervention: impact on preparedness for caregiving. Aging Clin Exp Res. 2025 Mar 1;37(1):64. doi: 10.1007/s40520-025-02959-z.
PMID: 40021531DERIVEDThompson RC, Gallagher VT, Reilly SE, Arp AM, Manning CA. Individualized Coordination and Empowerment for Care Partners of Persons with Dementia (ICECaP): Feasibility and acceptability. Contemp Clin Trials. 2025 Jan;148:107770. doi: 10.1016/j.cct.2024.107770. Epub 2024 Dec 2.
PMID: 39631536DERIVEDGallagher VT, Arp A, Thompson R, Rossetti A, Patrie J, Reilly SE, Manning CA. Randomized Clinical Trial of ICECaP (Individualized Coordination and Empowerment for Care Partners of Persons with Dementia): Primary Mental Health and Burden Outcomes. medRxiv [Preprint]. 2024 Aug 16:2024.08.15.24312041. doi: 10.1101/2024.08.15.24312041.
PMID: 39185526DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carol Manning, Ph.D.
University of Virginia Department of Neurology
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Harrison Distinguished Teaching Professor of Neurology, Vice Chair for Faculty Development, Director Memory Disorders Clinic
Study Record Dates
First Submitted
May 18, 2020
First Posted
August 3, 2020
Study Start
March 3, 2021
Primary Completion
September 1, 2025
Study Completion
September 1, 2025
Last Updated
November 29, 2023
Record last verified: 2023-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- SAP, CSR
- Time Frame
- We will make this final research data available by the time of publication of the main findings from the final dataset.
- Access Criteria
- we will make the final research data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
The final dataset will include self-reported demographic information and behavioral data from well-validated questionnaires. Because subjects will be recruited within the University of Virginia Memory and Aging Care Clinic and provided clinical services through this clinic that intersect with their participation in this study, we will be collecting identifying information. Even though the final dataset will be stripped of identifiers prior to release for sharing, we believe that there remains the possibility of deductive disclosure of subjects with unusual characteristics. We are specifically concerned about the potential for negative consequences subsequent to deductive disclosure due to the sensitive nature of the behavioral and diagnostic information being obtained in this study and the potential for these consequences to affect both the study subject and the PWD for whom they provide care.