Informed Consent Clinical Trial
— ECONSENTOfficial title:
Electronic Consent of Numerous Subjects Employing Novel Techniques Trial
Verified date | May 2018 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to compare the modular, multi-tiered consent process featured in Apple's ResearchKit (RK) to the standard consent process. The primary objective is to determine whether participants using the ResearchKit consent form have a significantly higher comprehension of the elements of consent than participants using the standard consent form.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | August 1, 2019 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age > 18 years - Able to read and understand study materials which are presented in English - Owns or has access to a smartphone or other smart device such as a tablet or iPod Exclusion Criteria: - Any physical limitations which prevent the participant from using mobile and/or touch screen technologies - Employed in a research position, clinical care position, or position which has regular exposure to clinical research |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Participant comprehension, as measured by Qualtrics survey | Participants will complete a questionnaire about the consent form after reading through the consent which will assess their comprehension of the contents of the consent process. | at study conclusion, an average of 15 minutes |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01546194 -
A Survey of Patient's Attitudes Towards Consent For Clinical Research In Anesthesiology
|
||
Completed |
NCT00899392 -
Improving Informed Consent in Pediatric Endoscopy
|
N/A | |
Completed |
NCT05505058 -
One-time Informed Consent for Research in Prison
|
N/A | |
Recruiting |
NCT06140043 -
Augmented Reality for Orthognatic Surgery Patient Education
|
Phase 2/Phase 3 | |
Completed |
NCT01933139 -
Informed Consent for Hysterectomy: Effectiveness of Audio-visual Presentations on Patient Comprehension
|
N/A | |
Completed |
NCT00032565 -
EQUIC-SM: Enhancing Quality of Informed Consent
|
N/A | |
Completed |
NCT01778582 -
Perspective-taking, and Examining the Clinical Trial Informed Consent Process
|
||
Not yet recruiting |
NCT06104137 -
MOOC Applications Related to Shared Decision Making in Bariatric Surgery
|
N/A | |
Not yet recruiting |
NCT04614688 -
Assessing the Impact of a Patient Education Platform to Augment the Informed Consent Process for Obstetrics and Gynecology Procedures
|
N/A | |
Completed |
NCT03960723 -
Descriptive Study to Evaluate the Understanding Degree of Informed Consent in Surgical Procedures
|
||
Completed |
NCT03555760 -
Patients' Readings of Pre-operative Informed Consent Forms
|
||
Completed |
NCT03405766 -
Barriers in the Process of Achieving Informed Consent From Critically Ill Patients
|
||
Recruiting |
NCT06192511 -
Implementing a Novel Consent Process for Biospecimen Research After Newborn Screening
|
N/A | |
Completed |
NCT02541799 -
Comprehension of Research Informed Consent When Applied Through a Telemedicine Medium
|
Phase 2 | |
Completed |
NCT01635842 -
Informed Consent and Clinical Trials
|
N/A | |
Withdrawn |
NCT02332837 -
Interactive Tool for Informed Consent
|
N/A | |
Completed |
NCT02885532 -
Capacity to Consent in Acutely Intoxicated Emergency Department Patients
|
N/A | |
Completed |
NCT03503487 -
Surgical Planning and Informed Consent
|
N/A | |
Completed |
NCT04627597 -
Patients' Comprehension and Internalization of Operative Consent Form
|
||
Completed |
NCT04493866 -
Quality Improvement Study on Operative Consent Forms
|