Skip to main content
OpenTrials
Completed

NCT Number: NCT04205396

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caregivers Ascites Brain Diseases Brain Diseases, Metabolic Cardiovascular Diseases Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Insufficiency Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

No treatment

Other

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Change in Visual Analogue Score (VAS)

    Time frame: 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.

  2. Change in Distress Thermometer (DT)

    Time frame: 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).

  3. Change in Caregiver Captivity Index (CCI)

    Time frame: 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

Other outcomes

  1. Rate of Healthcare utilization by care recipient

    Time frame: 6 months after randomization

    Number of hospitalizations, number of unscheduled outpatient visits, number of ER visits

Sponsors and collaborators

Lead sponsor

University of Michigan

Other

Registry information

Official study title

CAREGIVER: An Randomized Clinical Trial (RCT) to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 19, 2019
Registry last updated
Apr 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.