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

Not Applicable

Completed

• Conditions: Caregivers
• Interventions: Behavioral: Written emotional disclosure; Other: No treatment; Behavioral: Resilience training

• Registration Number: NCT04205396
• Lead Sponsor: University of Michigan

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Study Start: 2020-02-10
• Primary Completion: 2022-03-22
• Study Completion: 2022-03-22
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-13
• Last Update Posted: 2022-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Written emotional disclosure	Written emotional disclosure	-
Control arm	No treatment	-
Resilience training	Resilience training	-

Primary Outcome Measures

Name	Time	Method
Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)	At baseline and then at 4 week and 8 weeks	The short form of the ZBI is a validated short 12-item questionnaire measuring perceived burden associated with care giving. Participants rate each item on a 5-point scale ranging from 0 (never) to 4 (nearly always) the range of possible score is 0 (less burden) to 48 (more burden).

Secondary Outcome Measures

Name	Time	Method
Change in Distress Thermometer (DT)	At baseline and then at 4 week and 8 weeks	This is a single-item self-report measure of distress. The DT is presented as a 10-point scale in a thermometer format and asks to rate how distressed one felt in the previous week from 0 (not distressed) to 10 (extremely distressed).
Change in Visual Analogue Score (VAS)	At baseline and then at 4 week and 8 weeks	The VAS is a measure of health related quality of life (HRQOL). It is a scale from 0 to 100 where 0 represents the worst imaginable health state and 100 represents the best imaginable health state.
Change in Caregiver Captivity Index (CCI)	At baseline and then at 4 week and 8 weeks	A three-item self-report measure of how much (very much, somewhat, just a little, not at all) a caregiver feels like a captive, or being an unwilling or involuntary incumbent of a caregiver role. Scored on a scale of 4-12 with higher scores being worse

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States