Family Telemental Health Intervention for Veterans With Dementia (NCT03116464) | Clinical Trial Compass
TerminatedNot Applicable
Family Telemental Health Intervention for Veterans With Dementia
Stopped: Insufficient recruitment and resources to continue the study
United States4 participantsStarted 2017-09-18
Plain-language summary
Dementia impacts Veterans, their families, and other Veterans who serve as caregivers. One of the most stressful aspects of caregiving is the management of behavioral problems (e.g. wandering, agitation, and sleep difficulties), which exacerbate health issues for both caregivers and persons with dementia (PWD). Existing VA caregiver treatments for caregiver stress and behavioral problems are often ineffective. Many caregivers do not realize their interactions with PWD contribute to behavioral problems and thus do not ask for help to improve their interpersonal skills. The aim of this project is to develop an assessment of interpersonal skills deficits and a related treatment strategy to assist family caregivers of PWD who are challenged by a lack of interpersonal skills and are not helped by existing family caregiver treatments. This project, will develop and test (1) a video assessment of caregiver/PWD interaction that clinicians will use to identify interpersonal difficulties and (2) a family therapy for the interpersonal difficulties clinicians identify in the assessment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
Either the caregiver or the care-recipient must be a Veteran.
The caregiver must:
* Be the primary unpaid family or friend who helps or supports an individual with dementia
* Be involved in the care of the person with dementia (at least 4 hours of care per day)
* Report that the care-recipient exhibits behavioral problems that are distressing
* Not be currently receiving the REACH VA protocol
Additionally, the care-recipient must:
* Must have a documented diagnosis of dementia
* Have cognitive impairment (MMSE\<23 or SLUMS\<20 or diagnosis of dementia based on chart review)
* Be out of bed and able to respond to a caregiver's instructions or interventions
Exclusion Criteria:
* Caregiver severe cognitive impairment
* Caregiver inability to meet study demands
* Caregiver psychosis
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Healthy Aging Brain Center Monitor (HABC Monitor):
Timeframe: Post Treatment, an average of 12-18 weeks