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NCT03510260 · ClinicalTrials.gov registry record · NA
Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial
A NA study of Risk Reduction and Satisfaction, sponsored by The University of Texas Medical Branch, Galveston.
- Completed
- Registry status
- NA
- Development phase
- 105
- Enrollment target
- 1
- Study location
NCT03510260: Completed NA study of Risk Reduction and Satisfaction, sponsored by The University of Texas Medical Branch, Galveston.
NCT03510260 is a NA study of Risk Reduction and Satisfaction that has completed, run by The University of Texas Medical Branch, Galveston. The registered enrollment target is 105 participants, below the 3,690-participant average among 13 other Risk Reduction trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03510260, a NA study of Risk Reduction and Satisfaction, has completed, sponsored by The University of Texas Medical Branch, Galveston.
- COMPLETED
- Registry status
- NA
- Development phase
- 105 participants
- Enrollment target
- 1
- Study location
Study Summary
· The target population for our study is women who present in their last clinic visit before delivery and are scheduled for an elective cesarean section. In that visit, the provider will notify the research team in order for the subject to be screened for the study. If the subject consents to participation, written informed consent will be obtained by person-to-person contact. The PI, study coordinator, or a collaborator will be responsible for the informed consent. After in-formed consent is obtained, the patient will be randomized to the following study groups: The control group will undergo regular consenting only. Study group I (e-confirmed consent only) will receive an electronic invitation to complete the consent process electronically and will proceed through the Confirmed Consent system prior to arrival to labor and delivery on day of surgery, which is the routine patient flow at this time. After completion of the survey, the subject will sign the regular paper consent for the procedure as standard in our institution. The study group II will undergo the same intervention as group II but the COMRADE survey questionnaire will be obtained by phone or in person after the completion of the paper consent form.
Primary Outcome
a survey assessing understanding of procedure and satisfaction,
Conditions Studied
Interventions
- OTHER Control Group
- OTHER Study Group I
- OTHER Study Group II
Study Locations (1)
Texas
- UTMB Galveston - Galveston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2018-05-08 |
| Est. Completion | 2020-08-01 |
| Phase | NA |
What the finished NCT03510260 record still lists
NCT03510260 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, below the 3,690-participant average among 13 other Risk Reduction trials with a reported enrollment target (97% lower).
The record links to 2 conditions, with Risk Reduction appearing as the primary indexed condition, and to 3 interventions - of which Control Group is the first listed.
NCT03510260 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03510260 about?
NCT03510260 is a clinical study titled "Electronic Confirmed Versus Conventional Consenting Process: A Randomized Controlled Trial". · The target population for our study is women who present in their last clinic visit before delivery and are scheduled for an elective cesarean section. In that visit, the provider will notify the research team in order for the subject to be screened for the study. If the subject consents to partic...
What is the current status of trial NCT03510260?
This trial is currently completed. It is a NA study. The enrollment target is 105 participants. The study started on 2018-05-08. Estimated completion is 2020-08-01.
What conditions does trial NCT03510260 study?
This clinical trial studies the following conditions: Risk Reduction, Satisfaction.
What interventions are being tested in trial NCT03510260?
The interventions under investigation include: Control Group (OTHER), Study Group I (OTHER), Study Group II (OTHER).
Who is sponsoring clinical trial NCT03510260?
This trial is sponsored by The University of Texas Medical Branch, Galveston, which has 203 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03510260 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03510260's enrollment target sits among peer trials
105 10th of 13 higher than 4 of 13 other Risk Reduction trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Risk Reduction 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.
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