Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01704560 · ClinicalTrials.gov registry record · NA
Improving Measurement Of Parents' Understanding Of Research Permission
A NA study of Improve Parent Understanding of Research Permission, sponsored by University of Rochester.
- Completed
- Registry status
- NA
- Development phase
- 32
- Enrollment target
- 2
- Study locations
NCT01704560 is a NA study of Improve Parent Understanding of Research Permission that has completed, run by University of Rochester. The registered enrollment target is 32 participants. The trial reports 2 study locations across 1 state.
The verdict
NCT01704560, a NA study of Improve Parent Understanding of Research Permission, has completed, sponsored by University of Rochester.
- COMPLETED
- Registry status
- NA
- Development phase
- 32 participants
- Enrollment target
- 2
- Study locations
Study Summary
Well-informed potential subjects are presumably better able to make autonomous decisions about the risks and benefits of participating in a research study than those in possession of less information. In actuality, prior research into consent understanding suggests that longer forms offering exhaustive information may inhibit rather than promote understanding. Moreover, technical wording in tools used to measure parent understanding of research permission may also lead to inhibition of understanding. This study will test the hypothesis that, among parents of potential subjects for greater-than-minimal-risk research, two modified and simplified subset of questions from the Deaconess Informed Consent Comprehension Test (DICCT), one oral and open-ended and one written and multiple choice, will increase subject understanding of the nature and risks of the research. The study will enroll the parents of 40 potential neonatal research subjects with an interim analysis of data at 20 subjects. Subjects will review a sham research permission form and will be randomized 1:1 to complete one of the two modified comprehension tests in addition to the DICCT (gold-standard) test. Parents will be given an open-ended survey after the tests in order to qualitatively describe their opinions of each test. A subset of parents who have received the written form will also undergo a cognitive interview about the form. A similar subset will also be given an open-ended survey about a proposed permission form cover sheet. The primary outcome will be the correlation of scores between the DICCT and modified comprehension tests, following the sham informed consent process.
Conditions Studied
Interventions
- OTHER Coversheet to Informed Consent
Study Locations (2)
New York
- Women and Children's Hospital of Buffalo - Buffalo
- Ann Marie Scorsone - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 32 participants |
| Start Date | 2012-03-30 |
| Est. Completion | 2019-04-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01704560
The ClinicalTrials.gov registry entry for NCT01704560 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 32 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Rochester, which has 636 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Improve Parent Understanding of Research Permission appearing as the primary indexed condition, and to 1 intervention - of which Coversheet to Informed Consent is the first listed.
NCT01704560 reports 2 study locations spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01704560 about?
NCT01704560 is a clinical study titled "Improving Measurement Of Parents' Understanding Of Research Permission". Well-informed potential subjects are presumably better able to make autonomous decisions about the risks and benefits of participating in a research study than those in possession of less information. In actuality, prior research into consent understanding suggests that longer forms offering exhaust...
What is the current status of trial NCT01704560?
This trial is currently completed. It is a NA study. The enrollment target is 32 participants. The study started on 2012-03-30. Estimated completion is 2019-04-30.
What conditions does trial NCT01704560 study?
This clinical trial studies the following conditions: Improve Parent Understanding of Research Permission.
What interventions are being tested in trial NCT01704560?
The interventions under investigation include: Coversheet to Informed Consent (OTHER).
Who is sponsoring clinical trial NCT01704560?
This trial is sponsored by University of Rochester, which has 636 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01704560 being conducted?
This trial has 2 study locations across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.