Back to resultsCAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
Primary Purpose
Caregivers
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Written emotional disclosure
Resilience training
No treatment
Sponsored by
About this trial
This is an interventional treatment trial for Caregivers focused on measuring cirrhosis, hepatic encephalopathy, ascites, varices, liver disease, resilience training, expressive writing
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:
- 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
Sites / Locations
- The University of Michigan
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Other
Arm Label
Written emotional disclosure
Resilience training
Control arm
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Change in Visual Analogue Score (VAS)
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 Distress Thermometer (DT)
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 Caregiver Captivity Index (CCI)
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
Full Information
NCT ID
NCT04205396
First Posted
December 17, 2019
Last Updated
April 13, 2022
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT04205396
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
February 10, 2020 (Actual)
Primary Completion Date
March 22, 2022 (Actual)
Study Completion Date
March 22, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Caregivers
Keywords
cirrhosis, hepatic encephalopathy, ascites, varices, liver disease, resilience training, expressive writing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
87 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Written emotional disclosure
Arm Type
Experimental
Arm Title
Resilience training
Arm Type
Experimental
Arm Title
Control arm
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Written emotional disclosure
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Resilience training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
No treatment
Intervention Description
Participants will complete baseline and outcome assessments and no intervention will be conducted.
Primary Outcome Measure Information:
Title
Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12)
Description
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).
Time Frame
At baseline and then at 4 week and 8 weeks
Secondary Outcome Measure Information:
Title
Change in Visual Analogue Score (VAS)
Description
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.
Time Frame
At baseline and then at 4 week and 8 weeks
Title
Change in Distress Thermometer (DT)
Description
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).
Time Frame
At baseline and then at 4 week and 8 weeks
Title
Change in Caregiver Captivity Index (CCI)
Description
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
Time Frame
At baseline and then at 4 week and 8 weeks
Other Pre-specified Outcome Measures:
Title
Rate of Healthcare utilization by care recipient
Description
Number of hospitalizations, number of unscheduled outpatient visits, number of ER visits
Time Frame
6 months after randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elliot Tapper, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
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