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Clinical Informed Consent Format Evaluation

NCT02489682 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2024-02-06

No results posted yet for this study

Summary

This study evaluates the effectiveness of a patient-centered short written informed consent form and a patient-centered short video informed consent in a randomized controlled trial (control = traditional informed consent ). Primary outcome measures include critical knowledge acquisition, risk and benefit judgments, and desired enrollment in a hypothetical clinical trial. The investigators hypothesized that the patient-centered patient-designed consent forms (video and written format) would do as well as or outperform the traditional consent form on the primary outcomes.

Conditions

  • Consent Forms

Interventions

OTHER

Long-form written Informed consent information

OTHER

Short-form written Informed consent information

OTHER

Video Informed consent information

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2015-04-30
Completion
2015-05-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02489682 on ClinicalTrials.gov