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Sponsors and Collaborators: |
University of Pittsburgh University of California, San Francisco the UCSF/MtZion Health Fund |
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Information provided by: | University of Pittsburgh |
ClinicalTrials.gov Identifier: | NCT00177515 |
The purpose of this study is to determine whether "video doctor" programs can effectively deliver preventive health messages to women of reproductive age while they wait to be seen in urgent care settings. In this study, the specific hypotheses being tested are: 1) is the video doctor program effective in improving women's knowledge about emergency contraception, and 2) is the video doctor program effective in improving women's knowledge about the importance of folate.
Condition | Intervention | Phase |
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Preconception Care |
Behavioral: "video doctor," computer module |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double Blind (Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | Preventive Health Education for Women of Reproductive Age |
Enrollment: | 446 |
Study Start Date: | March 2005 |
Study Completion Date: | January 2007 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Computerized counseling about Emergency Contraception
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Behavioral: "video doctor," computer module
computerized counseling about emergency contraception and peri-conception folate
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2: Active Comparator
Computerized counseling about peri-conception folate
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Behavioral: "video doctor," computer module
computerized counseling about emergency contraception and peri-conception folate
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We will randomly assign participants to interact with one of two "video doctor" programs which have been been developed to convey messages appropriate for women of reproductive age.
The "video doctor" is an actress (not UCSF staff) following a script that has been designed through interdisciplinary collaboration here at UCSF. These particular video programs have not been used before, but similar ones have been studied and shown to be effective by Dr. Gerber in providing patients with information about how to decrease sexual risks and the harms of alcohol and drug use. Before interacting with the "video doctor" program, we will assess participants baseline knowledge of the importance of peri-conception folate and the option of emergency contraception. Participants will then interact with their "video doctor" and be provided with a free sample of the pills their video doctor discussed.
The first "video doctor" will educate women about the ability of folate to reduce birth defects. The discovery that peri-conception folate supplementation significantly decreases rates of neural tube defects has inspired multiple educational campaigns. However, recent work has shown that knowledge of the benefits of folate remains low, especially among minority populations.
The second "video doctor" message will inform women of the option of emergency contraception. Emergency contraception using high doses of progesterone has been shown to reduce the risk of pregnancy to less than 2% when used up to five days after a condom failure or an episode of unprotected sex.
This medication is not teratogenic and will not cause a miscarriage if used by a woman who does not know she is pregnant. Use of emergency contraception poses no long-term health risks to women and is available over-the-counter in seven European countries. Prior studies in family planning clinics , as well as the post-partum setting have shown that education about and advance provision of emergency contraceptive pills can increase knowledge and appropriate use of these pills, without adversely affecting sexual risk taking or other health behaviors. However, knowledge of emergency contraception remains limited, leading some to call it America's "best kept secret." Participants will be contacted by phone six months after interacting with the "video doctor" and asked to provide information about their use of folate and/or emergency contraception. One year after interacting with the "video doctor" participants will be contacted again and asked to provide further information about their use of folate and/or emergency contraception.
Ages Eligible for Study: | 18 Years to 45 Years |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |
University of California, San Francisco | |
San Francisco, California, United States, 94143 |
Principal Investigator: | Eleanor B Schwarz, MD | University of Pittsburgh |
Responsible Party: | University of Pittsburgh ( Eleanor Schwarz ) |
Study ID Numbers: | H2582-25916-01A |
Study First Received: | September 13, 2005 |
Last Updated: | August 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00177515 |
Health Authority: | United States: Food and Drug Administration |
emergency contraception folic acid education preventive health |
Folic Acid Emergencies |