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

Caregivers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04205396
• Other study ID #: HUM00167479
• Status: Completed
• Phase: N/A
• Start date: February 10, 2020
• Est. completion date: March 22, 2022

Study information

• Verified date: April 2022
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: March 22, 2022
• Est. primary completion date: March 22, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Caregivers
• Fibrosis

Intervention

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.
• 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.

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

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Healthcare utilization by care recipient	Number of hospitalizations, number of unscheduled outpatient visits, number of ER visits	6 months after randomization
Primary	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	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.	At baseline and then at 4 week and 8 weeks
Secondary	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).	At baseline and then at 4 week and 8 weeks
Secondary	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	At baseline and then at 4 week and 8 weeks