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NCT02081248 · ClinicalTrials.gov registry record · NA

Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)

A NA study of Improve the Informed Consent Process, sponsored by Medical College of Wisconsin.

Completed
Registry status
NA
Development phase
198
Enrollment target
20
Study locations

NCT02081248: Completed NA study of Improve the Informed Consent Process, sponsored by Medical College of Wisconsin.

NCT02081248 is a NA study of Improve the Informed Consent Process that has completed, run by Medical College of Wisconsin. The registered enrollment target is 198 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (86% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02081248, a NA study of Improve the Informed Consent Process, has completed, sponsored by Medical College of Wisconsin.

COMPLETED
Registry status
NA
Development phase
198 participants
Enrollment target
20
Study locations

Study Summary

The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.

Primary Outcome

The primary objective of the trial is to compare objective comprehension scores on the Quality of Informed Consent (part A) instrument between subjects randomized to the ETRIC versus the standard consent arms. The QuIC-A is scored on a normalized scale from 0 to 100, with a higher score indicating a greater level of comprehension.

Interventions

  • OTHER Consent Form Specific Format 1
  • OTHER Consent Form Specific Format 2

Study Locations (20)

Ohio

  • The Jewish Hospital BMT Program - Cincinnati
  • University Hospitals of Cleveland/Case Western - Cleveland
  • Cleveland Clinic Foundation - Cleveland
  • Ohio State/Arthur G. James Cancer Hospital - Columbus

Florida

  • University of Florida College of Medicine (Shands) - Gainesville
  • Florida Hospital Cancer Institute - Orlando
  • H. Lee Moffitt Cancer Center - Tampa

Georgia

  • Emory University - Atlanta
  • BMT Program at Northside Hospital - Atlanta

Minnesota

  • University of Minnesota - Minneapolis
  • Mayo Clinic - Rochester - Rochester

North Carolina

  • University of North Carolina Hospital at Chapel Hill - Chapel Hill
  • Duke University Medical Center - Durham

California

  • City of Hope National Medical Center - Duarte

Illinois

  • Loyola University Medical Center - Maywood

Kansas

  • University of Kansas - Lawrence

Trial Details

FieldValue
Enrollment Target 198 participants
Start Date 2013-12
Est. Completion 2016-08-03
Phase NA
Medical College of Wisconsin

447 total trials

What the finished NCT02081248 record still lists

NCT02081248 is an interventional study that assigns participants to a tested intervention. The registered 198 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 (86% lower).

The record links to 1 condition, with Improve the Informed Consent Process appearing as the primary indexed condition, and to 2 interventions - of which Consent Form Specific Format 1 is the first listed.

NCT02081248 names 20 study sites across 12 states, led by Ohio, Florida, Georgia.

Frequently Asked Questions

What is clinical trial NCT02081248 about?

NCT02081248 is a clinical study titled "Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN 1205)". The study has two parts: (1) Randomized Study to evaluate the effectiveness of ETRIC, and (2) Evaluation Study to understand barriers to implementation of ETRIC.

What is the current status of trial NCT02081248?

This trial is currently completed. It is a NA study. The enrollment target is 198 participants. The study started on 2013-12. Estimated completion is 2016-08-03.

What conditions does trial NCT02081248 study?

This clinical trial studies the following conditions: Improve the Informed Consent Process.

What interventions are being tested in trial NCT02081248?

The interventions under investigation include: Consent Form Specific Format 1 (OTHER), Consent Form Specific Format 2 (OTHER).

Who is sponsoring clinical trial NCT02081248?

This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02081248 being conducted?

This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

How this trial's enrollment target compares

Where NCT02081248's enrollment target sits among peer trials

198 567th of 2000 higher than 1,434 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 NCT02081248, the US trial registry maintained by the National Library of Medicine. NCT02081248 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.