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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 is a Phase 2 study that has completed, run by University of Wisconsin, Madison. The registered enrollment target is 20 participants.
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
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2003-10 |
| Est. Completion | 2007-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00214344
The ClinicalTrials.gov registry entry for NCT00214344 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Wisconsin, Madison, which has 1,039 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which family preparation for withdrawing life support is the first listed.
NCT00214344 reports 0 study locations.
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.
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