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NCT04205396 · ClinicalTrials.gov registry record · NA

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

A NA study of Caregivers, sponsored by University of Michigan.

Completed
Registry status
NA
Development phase
87
Enrollment target
1
Study location

NCT04205396: Completed NA study of Caregivers, sponsored by University of Michigan.

NCT04205396 is a NA study of Caregivers that has completed, run by University of Michigan. The registered enrollment target is 87 participants, roughly in line with the 95-participant average among 15 other Caregivers trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04205396, a NA study of Caregivers, has completed, sponsored by University of Michigan.

COMPLETED
Registry status
NA
Development phase
87 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

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).

Conditions Studied

Interventions

  • OTHER No treatment
  • BEHAVIORAL Written emotional disclosure
  • BEHAVIORAL Resilience training

Study Locations (1)

Michigan

  • The University of Michigan - Ann Arbor

Trial Details

FieldValue
Enrollment Target 87 participants
Start Date 2020-02-10
Est. Completion 2022-03-22
Phase NA
University of Michigan

1,327 total trials

What the finished NCT04205396 record still lists

NCT04205396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, roughly in line with the 95-participant average among 15 other Caregivers trials with a reported enrollment target.

The record links to 1 condition, with Caregivers appearing as the primary indexed condition, and to 3 interventions - of which No treatment is the first listed.

NCT04205396 reports a single indexed study location in Michigan.

Frequently Asked Questions

What is clinical trial NCT04205396 about?

NCT04205396 is a clinical study titled "CAREGIVER: A Trial to Improve the Burden and Distress of Caring for Persons With Decompensated Cirrhosis". 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...

What is the current status of trial NCT04205396?

This trial is currently completed. It is a NA study. The enrollment target is 87 participants. The study started on 2020-02-10. Estimated completion is 2022-03-22.

What conditions does trial NCT04205396 study?

This clinical trial studies the following conditions: Caregivers.

What interventions are being tested in trial NCT04205396?

The interventions under investigation include: No treatment (OTHER), Written emotional disclosure (BEHAVIORAL), Resilience training (BEHAVIORAL).

Who is sponsoring clinical trial NCT04205396?

This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04205396 being conducted?

This trial has 1 study location across Michigan. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Caregivers

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04205396's enrollment target sits among peer trials

87 6th of 15 higher than 10 of 15 other Caregivers trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Caregivers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04205396, the US trial registry maintained by the National Library of Medicine. NCT04205396 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.