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Trial to Compare eConsent With Standard Consent Among Prospective Biobank Participants

NCT04131062 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 703

Last updated 2022-12-27

No results posted yet for this study

Summary

The goal of this trial is to determine whether the Sage eConsent framework (presented using an electronic application) is non-inferior to traditional, paper-based, human-mediated consent-and therefore could be part of an acceptable population screening approach to identifying patients and others with actionable hereditary syndromes-and to increase basic knowledge about patients' informational needs about different aspects of genetic/omic screening. After receiving either 1) the traditional consenting approach, or 2) a consenting approach presented on an electronic tablet, the investigators will test for differences between these two arms in a variety of outcome measures including objective and perceived comprehension, time spent and informational needs, and enrollment decision, among others.

Conditions

Interventions

BEHAVIORAL

Electronic Consent (iPad)

Participants who receive the intervention will be consented using an electronic app presented via iPad and developed according to the Sage eConsent framework.

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Geisinger Clinic

    lead OTHER

Principal Investigators

  • Michelle N Meyer, PhD, JD · Geisinger Clinic

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-11-01
Primary Completion
2022-05-19
Completion
2022-05-19

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT04131062 on ClinicalTrials.gov