CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Ci… (NCT04205396) | Clinical Trial Compass
CompletedNot Applicable
CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
United States87 participantsStarted 2020-02-10
Plain-language summary
The goal of this study is to enroll caretakers of patients with decompensated cirrhosis to determine if written emotional disclosure or resilience training interventions reduce distress and burden among primary informal caregivers.
Caretakers that meet eligibility will complete baseline assessments in person, or if necessary, over the phone and be randomized to be in one of three arms of this study. Materials specific to each study arm will be mailed to the caretakers home along with instructions. Overall, the study will take approximately 2 months and a qualitative interview will also be completed around 3-6 months post-baseline.
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
. Child-Turcotte Pugh (CTP) Class A/B/C cirrhosis with an all cause hospitalization within the previous 30 days.
. CTP Class B or C cirrhosis with one of the following within the prior 6 months from the date of enrollment:
. Ascites (requiring paracentesis or diuretics)
. Overt Hepatic Encephalopathy (requiring lactulose or rifaximin/flagyl/neomycin)
. Spontaneous Bacterial Peritonitis (SBP)
. Hepatic Hydrothorax (requiring diuretics or thoracentesis)
. Variceal Bleed (with 1 or more recurrences)
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
Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)
Timeframe: At baseline and then at 4 week and 8 weeks