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NCT01259011 · ClinicalTrials.gov registry record · NA

A Representational Intervention to Promote Preparation for End-of-life Decision Making

A NA study, sponsored by University of North Carolina, Chapel Hill.

Completed
Registry status
NA
Development phase
210
Enrollment target

NCT01259011: Completed NA study, sponsored by University of North Carolina, Chapel Hill.

NCT01259011 is a NA study that has completed, run by University of North Carolina, Chapel Hill. The registered enrollment target is 210 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01259011, a NA study, has completed, sponsored by University of North Carolina, Chapel Hill.

COMPLETED
Registry status
NA
Development phase
210 participants
Enrollment target

Study Summary

The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness Representations to Increase Trust) intervention designed to improve discussions about end-of-life care between patients and their surrogate decision makers. Subjects will be 200 Caucasian and African-American patients with ESRD (end-stage renal disease) recruited from outpatient dialysis clinics and their chosen surrogate decision makers. We hypothesize that (1) SPIRIT will lead to significantly less patient decisional conflict and significantly greater dyad congruence and surrogate decision making confidence than the standard care control at 2, 6, and 12 months post-intervention and (2) SPIRIT will reduce surrogate decisional conflict and psychosocial morbidities at 2 weeks after the patient's hospitalization requiring surrogate decision making significantly more than the standard care control.

Primary Outcome

patient and surrogate congruence on the goals of care

Interventions

  • BEHAVIORAL the SPIRIT intervention

Trial Details

FieldValue
Enrollment Target 210 participants
Start Date 2010-03
Est. Completion 2014-04
Phase NA

What the finished NCT01259011 record still lists

NCT01259011 is an interventional study that assigns participants to a tested intervention. The registered 210 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (85% lower).

The record links to 0 conditions, and to 1 intervention - of which the SPIRIT intervention is the first listed.

NCT01259011 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01259011 about?

NCT01259011 is a clinical study titled "A Representational Intervention to Promote Preparation for End-of-life Decision Making". The proposed randomized controlled trial will test the SPIRIT (Sharing the Patient's Illness Representations to Increase Trust) intervention designed to improve discussions about end-of-life care between patients and their surrogate decision makers. Subjects will be 200 Caucasian and African-America...

What is the current status of trial NCT01259011?

This trial is currently completed. It is a NA study. The enrollment target is 210 participants. The study started on 2010-03. Estimated completion is 2014-04.

What interventions are being tested in trial NCT01259011?

The interventions under investigation include: the SPIRIT intervention (BEHAVIORAL).

Who is sponsoring clinical trial NCT01259011?

This trial is sponsored by University of North Carolina, Chapel Hill, which has 1,109 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01259011's enrollment target sits among peer trials

210 490th of 2000 higher than 1,505 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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 NCT01259011, the US trial registry maintained by the National Library of Medicine. NCT01259011 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.