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

  • STATUS
    Recruiting
  • End date
    Dec 3, 2022
  • participants needed
    90
  • sponsor
    University of Michigan
Updated on 3 June 2021

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.

Details
Condition Caregiver
Treatment No Treatment, Written emotional disclosure, Resilience training
Clinical Study IdentifierNCT04205396
SponsorUniversity of Michigan
Last Modified on3 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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

Exclusion Criteria

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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