An Interactive Informed Consent and Education Program for Pregnant Women
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| First Received Date ICMJE | August 3, 2010 | ||||||||||||
| Last Updated Date | September 13, 2011 | ||||||||||||
| Start Date ICMJE | August 2010 | ||||||||||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Current Primary Outcome Measures ICMJE |
Difference in understanding/knowledge gain as compared to control [ Time Frame: Post-test and 2 week follow-up ] [ Designated as safety issue: No ] Open-ended and T/F questionnaire designed to determine if the ArchieMD Interactive Informed Consent and Education Program for Pregnant Women improves understanding and expectations of prenatal screening and diagnostic tests in a group of pregnant women patients. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||||||
| Change History | Complete list of historical versions of study NCT01176019 on ClinicalTrials.gov Archive Site | ||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||||||
| Descriptive Information | |||||||||||||
| Brief Title ICMJE | An Interactive Informed Consent and Education Program for Pregnant Women | ||||||||||||
| Official Title ICMJE | An Interactive Informed Consent and Education Program for Pregnant Women | ||||||||||||
| Brief Summary | The purpose of this study is to determine whether an interactive education program for prenatal testing is effective in improving pregnant women's understanding of and expectations towards prenatal screening and diagnosis. |
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| Detailed Description | Women face a variety of medical decisions during pregnancy and childbirth. While there are extensive educational resources for pregnant women, modern medicine presents decisions that many women are poorly equipped to make. Issues such as prenatal screening and mode of birth after a cesarean delivery require a significant degree of patient education to enable a truly informed medical decision. Studies have shown that women have a poor understanding of screening for birth defects and mode of birth after a cesarean delivery. Women with a low level of education or poor health literacy are significantly more likely to demonstrate inadequate understanding of prenatal screening. ArchieMD, Inc. has developed a comprehensive interactive medical simulation environment which has the potential to visually convey complex information to patients to improve understanding of medical procedures and educate patients on the consequences of their behavior. We hypothesize that such an interactive medical simulation patient education program can improve patient understanding allowing pregnant women to make informed decisions. In Phase I, we will prototype an interactive patient education program for prenatal screening and amniocentesis. |
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| Study Type ICMJE | Interventional | ||||||||||||
| Study Phase | Phase 1 | ||||||||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Health Services Research |
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| Condition ICMJE |
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| Intervention ICMJE | Device: Information about Prenatal Screening and Diagnosis
15-20 minute interactive video about prenatal screening and diagnosis given on day of recruitment. |
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| Study Arm (s) |
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| Publications * | Not Provided | ||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||
| Recruitment Status ICMJE | Completed | ||||||||||||
| Enrollment ICMJE | 150 | ||||||||||||
| Completion Date | March 2011 | ||||||||||||
| Primary Completion Date | March 2011 (final data collection date for primary outcome measure) | ||||||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||||||
| Ages | 18 Years and older | ||||||||||||
| Accepts Healthy Volunteers | Yes | ||||||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||||||
| Location Countries ICMJE | United States | ||||||||||||
| Administrative Information | |||||||||||||
| NCT Number ICMJE | NCT01176019 | ||||||||||||
| Other Study ID Numbers ICMJE | NIH-291 | ||||||||||||
| Has Data Monitoring Committee | Yes | ||||||||||||
| Responsible Party | William Grobman, Northwestern University | ||||||||||||
| Study Sponsor ICMJE | Northwestern University | ||||||||||||
| Collaborators ICMJE | ArchieMD | ||||||||||||
| Investigators ICMJE |
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| Information Provided By | Northwestern University | ||||||||||||
| Verification Date | September 2011 | ||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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