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

NCT04205396 | Completed

• 1 other identifier: HUM00167479
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

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.

Conditions

Caregivers

Keywords

cirrhosis; hepatic encephalopathy; ascites; varices; liver disease; resilience training; expressive writing

Outcome Measures

Primary Outcomes (1)

• Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)

  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).

  At baseline and then at 4 week and 8 weeks

Secondary Outcomes (3)

• Change in Visual Analogue Score (VAS)

  At baseline and then at 4 week and 8 weeks

• Change in Distress Thermometer (DT)

  At baseline and then at 4 week and 8 weeks

• Change in Caregiver Captivity Index (CCI)

  At baseline and then at 4 week and 8 weeks

Other Outcomes (1)

• Rate of Healthcare utilization by care recipient

  6 months after randomization

Study Arms (3)

Written emotional disclosure

EXPERIMENTAL

Behavioral: Written emotional disclosure

Resilience training

EXPERIMENTAL

Behavioral: Resilience training

Control arm

OTHER

Other: No treatment

Interventions

Written emotional disclosure BEHAVIORAL

Participants will write five stories (days 8, 11, 14, 17 and 20) about an assigned topic relating to their experiences as a caregiver of someone with advanced liver disease. Rules for the exercise will be provided in an instructions page. Additionally, baseline and outcome measures will be completed.

Written emotional disclosure

Resilience training BEHAVIORAL

Participants will write three things that went well at the end of their day (before going to sleep), and what was their role in bringing them. These will be done about every three days (days 8, 11, 14, 17 and 20) for 2 weeks at home. Rules for the exercise will be provided in an instructions page. Additionally, baseline and outcome measures will be completed.

Resilience training

No treatment OTHER

Participants will complete baseline and outcome assessments and no intervention will be conducted.

Control arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Tapper EB, Saleh ZM, Lizza S, Chen X, Nikirk S, Serper M. CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. Dig Dis Sci. 2023 Sep;68(9):3625-3633. doi: 10.1007/s10620-023-08042-9. Epub 2023 Jul 27.

  PMID: 37498415 DERIVED

MeSH Terms

Conditions

Fibrosis; Hepatic Encephalopathy; Ascites; Varicose Veins; Liver Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Elliot Tapper, MD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Internal Medicine

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: February 10, 2020
• Primary Completion: March 22, 2022
• Study Completion: March 22, 2022
• Last Updated: April 15, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)