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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Written emotional disclosure | Experimental |
| |
| Resilience training | Experimental |
| |
| Control arm | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Change in Distress Thermometer (DT) |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Healthcare utilization by care recipient | Number of hospitalizations, number of unscheduled outpatient visits, number of ER visits | 6 months after randomization |
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:
Hepatocellular Carcinoma (HCC)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elliot Tapper, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37498415 | Derived | Tapper EB, Saleh ZM, Lizza S, Chen X, Nikirk S, Serper M. CAREGIVER Randomized Trial of Two Mindfulness Methods to Improve the Burden and Distress of Caring for Persons with Cirrhosis. Dig Dis Sci. 2023 Sep;68(9):3625-3633. doi: 10.1007/s10620-023-08042-9. Epub 2023 Jul 27. |
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| ID | Term |
|---|---|
| D005355 | Fibrosis |
| D006501 | Hepatic Encephalopathy |
| D001201 | Ascites |
| D014648 | Varicose Veins |
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D017093 | Liver Failure |
| D048550 | Hepatic Insufficiency |
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|
| 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. |
|
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 |
| 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 |
| D004066 | Digestive System Diseases |
| D001928 | Brain Diseases, Metabolic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |