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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-10

Study Completion Date

2022-03-22

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Nurse Assisted Post-discharge Intervention in Decompensated Cirrhosis

NCT04158986

Liver Cirrhosis

COMPLETED NA

CirrhoCare- Using Smart-phone Technology to Enhance Care and Access to Treatment for Cirrhosis

NCT06223893

Decompensated Cirrhosis

RECRUITING NA

Mindfulness and Support Group to Improve Patient and Caregiver Burden in Cirrhosis

NCT02944643

Cirrhosis

COMPLETED NA

Health IT Generated PROs to Improve Outcomes in Cirrhosis

NCT03564626

Cirrhosis

COMPLETED NA

Cirrhosis Care Alberta (CCAB): A Pragmatic Type II Hybrid Effectiveness Implementation Trial

NCT04149223

Cirrhosis, Liver

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Caregivers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Written emotional disclosure

Group Type EXPERIMENTAL

Written emotional disclosure

Intervention Type 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.

Resilience training

Group Type EXPERIMENTAL

Resilience training

Intervention Type 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.

Control arm

Group Type OTHER

No treatment

Intervention Type OTHER

Participants will complete baseline and outcome assessments and no intervention will be conducted.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type 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.

Intervention Type BEHAVIORAL

No treatment

Participants will complete baseline and outcome assessments and no intervention will be conducted.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No