CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis
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|ClinicalTrials.gov 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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|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.
Other: No treatment
Participants will complete baseline and outcome assessments and no intervention will be conducted.
- 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).
- 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.
- 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).
- 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
- 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
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 ClinicalTrials.gov identifier (NCT number): NCT04205396
|United States, Michigan|
|The University of Michigan|
|Ann Arbor, Michigan, United States, 48109|
|Principal Investigator:||Elliot Tapper, MD||University of Michigan|