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

University of Michigan

Status: Completed

Conditions: Caregivers

Treatments: Behavioral: Resilience training; Behavioral: Written emotional disclosure; Other: No treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04205396

HUM00167479

Details and patient eligibility

About

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.

Enrollment: 87 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Primary informal caregiver for a patient with a clinical diagnosis of decompensated cirrhosis with either of the following three clinical criteria:

  1. Child-Turcotte Pugh (CTP) Class A/B/C cirrhosis with an all cause hospitalization within the previous 30 days.

  2. CTP Class B or C cirrhosis with one of the following within the prior 6 months from the date of enrollment:

     1. Ascites (requiring paracentesis or diuretics)
     2. Overt Hepatic Encephalopathy (requiring lactulose or rifaximin/flagyl/neomycin)
     3. Spontaneous Bacterial Peritonitis (SBP)
     4. Hepatic Hydrothorax (requiring diuretics or thoracentesis)
     5. Variceal Bleed (with 1 or more recurrences)

  3. Hepatocellular Carcinoma (HCC)

     1. Any Barcelona Clinic Liver Cancer (BCLC) Stage with CTP Class B or C
     2. 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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87 participants in 3 patient groups

Written emotional disclosure

Experimental group

Treatment:

Behavioral: Written emotional disclosure

Resilience training

Experimental group

Treatment:

Behavioral: Resilience training

Control arm

Other group

Treatment:

Other: No treatment