CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis

Completed · Not applicable

Conditions studied: Caregivers

In brief

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.

Key facts

Study ID

NCT04205396

Run by

University of Michigan

People needed

87

Starts

2020-02-10

Expected to finish

2022-03-22

Last updated by the study team

2022-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Primary informal caregiver for a patient with a clinical diagnosis of decompensated cirrhosis with either of the following three clinical 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)
• Hepatocellular Carcinoma (HCC)
• Any Barcelona Clinic Liver Cancer (BCLC) Stage with CTP Class B or C
• BCLC Stage C or D with CTP Class A

You may not qualify if…

• Non-English speaking
• Unable or unwilling to provide verbal consent
• Severe cognitive impairment
• Caregiver is participating in another interventional study
• Caregiver has used a personal diary within the past 12 months

Where it is running

• The University of Michigan — Ann Arbor, Michigan, United States

Full record on ClinicalTrials.gov

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