CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 198 enrolled
Drug / intervention
Consent Form Specific Format 1 +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02081248
NCT02081248N/ACompleted
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Easy-to-Read Informed Consent (ETRIC) for Hematopoietic Cell Transplantation Clinical Trials (BMT CTN #1205)

Medical College of Wisconsin·interventional·Posted Mar 7, 2014·Updated Dec 8, 2022

In Brief

A clinical study evaluating Consent Form Specific Format 1 and Consent Form Specific Format 2 for Improve the Informed Consent Process. Completed, enrolled 198 participants across 23 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsImprove the Informed Consent Process
CountriesUnited States
CollaboratorsNational Heart, Lung, and Blood Institute (NHLBI), National Cancer Institute (NCI), Blood and Marrow Transplant Clinical Trials Network, National Marrow Donor Program

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 7, 2014
Enrollment StartDec 1, 2013
Primary CompletionAug 3, 2016
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 12.3 years ago

Interventions

Consent Form Specific Format 1other

The Consent Form Specific Format 1 is the 'Standard Consent'. The standard consent does not have the format of two-columns with changes in layout readability, organization of content, typography and use of plain language. Standard consents are already used by sites for the BMT CTN 0901, 1101, 1203, and 1301 clinical trials.

Consent Form Specific Format 2other

The Consent Form Specific Format 2 is the 'Easy-to-Read Informed Consent'.The Easy-to-Read Informed Consent is two-columns with changes in layout readability, organization of content, typography and use of plain language.