Clinical trial NCT04205396: CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
Official title: CAREGIVER: An Randomized Clinical Trial (RCT) to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Caregivers
Keywords: cirrhosis
hepatic encephalopathy
ascites
varices
liver disease
resilience training
expressive writing
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2019-12-19
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)
timeFrame: At baseline and then at 4 week and 8 weeks
Secondary outcomes:
measure: Change in Visual Analogue Score (VAS)
timeFrame: At baseline and then at 4 week and 8 weeks
measure: Change in Distress Thermometer (DT)
timeFrame: At baseline and then at 4 week and 8 weeks
measure: Change in Caregiver Captivity Index (CCI)
timeFrame: At baseline and then at 4 week and 8 weeks
Other outcomes:
measure: Rate of Healthcare utilization by care recipient
timeFrame: 6 months after randomization
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Elliot Tapper, MD
role: PRINCIPAL_INVESTIGATOR
References: