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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT04205396
Recruitment Status : Suspended (Enrollment is temporarily paused due to COVID-19; interactions/interventions with current participants continue. This is not a suspension of IRB approval.)
First Posted : December 19, 2019
Last Update Posted : April 30, 2020
Information provided by (Responsible Party):
Elliot B. Tapper, 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.

Condition or disease Intervention/treatment Phase
Caregivers Behavioral: Written emotional disclosure Behavioral: Resilience training Other: No treatment Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: CAREGIVER: An Randomized Clinical Trial (RCT) to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
Actual Study Start Date : February 10, 2020
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Arm Intervention/treatment
Experimental: Written emotional disclosure Behavioral: Written emotional disclosure
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.

Experimental: Resilience training Behavioral: Resilience training
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.

Control arm Other: No treatment
Participants will complete baseline and outcome assessments and no intervention will be conducted.

Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04205396

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United States, Michigan
The University of Michigan
Ann Arbor, Michigan, United States, 48109
Sponsors and Collaborators
University of Michigan
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Principal Investigator: Elliot Tapper, MD University of Michigan
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Responsible Party: Elliot B. Tapper, Assistant Professor of Internal Medicine, University of Michigan Identifier: NCT04205396    
Other Study ID Numbers: HUM00167479
First Posted: December 19, 2019    Key Record Dates
Last Update Posted: April 30, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Elliot B. Tapper, University of Michigan:
hepatic encephalopathy
liver disease
resilience training
expressive writing
Additional relevant MeSH terms:
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Liver Cirrhosis
Pathologic Processes
Liver Diseases
Digestive System Diseases