Computer-assisted Preventive Health Education for Women of Reproductive Age in Urgent Care Settings

This study has been completed.
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00177515
First received: September 13, 2005
Last updated: May 4, 2010
Last verified: May 2010
  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

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00177515

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of Pittsburgh
University of California, San Francisco
Investigators
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 July 22, 2014