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NCT05587517 · ClinicalTrials.gov registry record · Phase 2
A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients
A Phase 2 study of Trauma and Grief, sponsored by Weill Medical College of Cornell University.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 172
- Enrollment target
- 3
- Study locations
NCT05587517: Recruiting Phase 2 study of Trauma and Grief, sponsored by Weill Medical College of Cornell University.
NCT05587517 is a Phase 2 study of Trauma and Grief that is actively recruiting participants, run by Weill Medical College of Cornell University. The registered enrollment target is 172 participants, below the 304-participant average among 56 other Trauma trials with a reported enrollment target (43% lower). The trial reports 3 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05587517, a Phase 2 study of Trauma and Grief, is actively recruiting participants, sponsored by Weill Medical College of Cornell University.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 172 participants
- Enrollment target
- 3
- Study locations
Study Summary
Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patients' value-concordant care (secondary outcomes) at T1-T4. Hypothesis 2. Qualitative data will provide insights not captured by quantitative data. Hypothesis 3. Reductions in experiential avoidance will mediate reductions in grief and Post Traumatic Stress Disorder (PTSD) symptoms, highlighting it as important to target in future implementation.
Primary Outcome
Symptoms of prolonged grief disorder, as measured by the Prolonged Grief-13-Revised, will be compared between the week following the intervention, at one month follow-up and at twelve-month follow-up . The PG-13-R consists of 13 items and total score can range from 0 to 62. Higher total scores represent greater symptom burden. Lower scores represent better outcomes.
Conditions Studied
Interventions
- BEHAVIORAL EMPOWER
- OTHER Supportive Conversation
Study Locations (3)
New York
- Memorial Sloan Kettering Cancer Center - New York
- NewYork-Presbyterian Weill Cornell Medicine - New York
Florida
- University of Miami - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 172 participants |
| Start Date | 2022-10-11 |
| Est. Completion | 2027-12-11 |
| Phase | Phase 2 |
What NCT05587517 shows while recruiting
NCT05587517 is an interventional study that assigns participants to a tested intervention. The registered 172 participants enrollment target is mid-sized for trials with a published cap, below the 304-participant average among 56 other Trauma trials with a reported enrollment target (43% lower).
The record links to 4 conditions, with Trauma appearing as the primary indexed condition, and to 2 interventions - of which EMPOWER is the first listed.
NCT05587517 reports a single indexed study location in New York, Florida.
Frequently Asked Questions
What is clinical trial NCT05587517 about?
NCT05587517 is a clinical study titled "A Clinical Trial of Interventions to Support Family Surrogates of Critically Ill Patients". Hypotheses 1a and 1b: Compared to Supportive Conversation arm, the EMPOWER intervention will significantly decrease surrogate decision makers' symptoms of grief and Post Traumatic Stress Disorder (PTSD) (primary outcomes); and H1b. experiential avoidance, depression, regrets, and increases in patien...
What is the current status of trial NCT05587517?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 172 participants. The study started on 2022-10-11. Estimated completion is 2027-12-11.
What conditions does trial NCT05587517 study?
This clinical trial studies the following conditions: Trauma, Grief, Critical Care, Psychotherapy.
What interventions are being tested in trial NCT05587517?
The interventions under investigation include: EMPOWER (BEHAVIORAL), Supportive Conversation (OTHER).
Who is sponsoring clinical trial NCT05587517?
This trial is sponsored by Weill Medical College of Cornell University, which has 701 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05587517 being conducted?
This trial has 3 study locations across Florida, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05587517's enrollment target sits among peer trials
172 22nd of 56 higher than 35 of 56 other Trauma trials
participants (enrollment target), bucketed by value
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