Computer-assisted Preventive Health Education for Women of Reproductive Age in Urgent Care Settings
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Purpose
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 |
|---|---|---|
|
Preconception Care |
Behavioral: "video doctor," computer module |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | Preventive Health Education for Women of Reproductive Age |
- Use of Emergency Contraception [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- Use of Folate supplements [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- Access to Emergency Contraception at home [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- Knowledge of emergency contraception [ Time Frame: 7 months ] [ Designated as safety issue: No ]
- Knowledge of the benefits of folate supplementation [ Time Frame: 7 months ] [ Designated as safety issue: No ]
| 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 |
|---|---|
|
Experimental: 1
Computerized counseling about Emergency Contraception
|
Behavioral: "video doctor," computer module
computerized counseling about emergency contraception and peri-conception folate
Other Name: EC and folate arms
|
|
Active Comparator: 2
Computerized counseling about peri-conception folate
|
Behavioral: "video doctor," computer module
computerized counseling about emergency contraception and peri-conception folate
Other Name: EC and folate arms
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 45 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- 18-45 year old English-speaking women
Exclusion Criteria:
- current pregnancy
- history of tubal ligation
- hysterectomy
- partner with a vasectomy
- no sex with men
- will not be able to be reached by telephone in 6 months
Contacts and Locations| United States, California | |
| University of California, San Francisco | |
| San Francisco, California, United States, 94143 | |
| Principal Investigator: | Eleanor B Schwarz, MD | University of Pittsburgh |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Eleanor Schwarz, University of Pittsburgh |
| ClinicalTrials.gov Identifier: | NCT00177515 History of Changes |
| Other Study ID Numbers: | H2582-25916-01A |
| Study First Received: | September 13, 2005 |
| Last Updated: | May 4, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by University of Pittsburgh:
|
emergency contraception folic acid education preventive health |
Additional relevant MeSH terms:
|
Folic Acid Vitamin B Complex Vitamins Micronutrients Growth Substances |
Physiological Effects of Drugs Pharmacologic Actions Hematinics Hematologic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 21, 2013