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NCT00214344 · ClinicalTrials.gov registry record · Phase 2

Family Preparation Study For Withdrawal of Mechanical Ventilation From Their Family Member

A Phase 2 study, sponsored by University of Wisconsin, Madison.

Completed
Registry status
Phase 2
Development phase
20
Enrollment target

NCT00214344: Completed Phase 2 study, sponsored by University of Wisconsin, Madison.

NCT00214344 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 20 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00214344, a Phase 2 study, has completed, sponsored by University of Wisconsin, Madison.

COMPLETED
Registry status
Phase 2
Development phase
20 participants
Enrollment target

Study Summary

Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. The site used for this study will be the Trauma and Life Support Center (TLC), University of Wisconsin (UW) Hospital. After a decision has been made to withdraw life support, a member of the TLC staff will approach the next of kin of the patient to inform him/her about the study and inquire about his/her interest to participate. Using an experimental design, 10 family members will be assigned to the control group and 10 to the intervention group. Upon agreement, a research nurse will use a "coin toss method" for group assignment of the subjects until there are ten in each group. Experimental group subjects will receive the intervention after the family meeting. Demographics of the next of kin will be collected at this time. Patient information such as demographics, diagnosis, and time of withdrawal and death will be collected too. Two to four weeks after death, a telephone interview will be conducted with the next of kin using the "Evaluation of the Experience of Withdrawal" questionnaire and the Profile of Mood State - shortened version. Potential benefits are that the families will be prepared for the experience of the dying patient, which will help them cope better during withdrawal and after their loss. There are no major risks to the subjects but there might be an increase in psychological distress.

Interventions

  • BEHAVIORAL family preparation for withdrawing life support

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2003-10
Est. Completion 2007-02
Phase Phase 2
University of Wisconsin, Madison

1,039 total trials

What the finished NCT00214344 record still lists

NCT00214344 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which family preparation for withdrawing life support is the first listed.

NCT00214344 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00214344 about?

NCT00214344 is a clinical study titled "Family Preparation Study For Withdrawal of Mechanical Ventilation From Their Family Member". Using the self-regulation theory, an intervention to prepare families for that experience was developed. This study will assess the impact of the intervention on a family's evaluation of their preparation and their short-term coping. The site used for this study will be the Trauma and Life Support C...

What is the current status of trial NCT00214344?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2003-10. Estimated completion is 2007-02.

What interventions are being tested in trial NCT00214344?

The interventions under investigation include: family preparation for withdrawing life support (BEHAVIORAL).

Who is sponsoring clinical trial NCT00214344?

This trial is sponsored by University of Wisconsin, Madison, which has 1,039 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00214344's enrollment target sits among peer trials

20 1805th of 2000 higher than 107 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT00214344, the US trial registry maintained by the National Library of Medicine. NCT00214344 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.