Caregivers
Conditions
Keywords
cirrhosis, hepatic encephalopathy, ascites, varices, liver disease, resilience training, expressive writing
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.
Interventions
BEHAVIORALWritten 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.
BEHAVIORALResilience 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.
OTHERNo treatment
Participants will complete baseline and outcome assessments and no intervention will be conducted.
Sponsors
University of Michigan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in burden of caregivers measured using the Zarit Burden Interview (ZBI -12) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Score (VAS) | 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) | 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) | 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
| Measure | Time frame | Description |
|---|---|---|
| Rate of Healthcare utilization by care recipient | 6 months after randomization | Number of hospitalizations, number of unscheduled outpatient visits, number of ER visits |
Countries
United States
Outcome results
None listed