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

May 4, 2010 updated by: University of Pittsburgh

Preventive Health Education for Women of Reproductive Age

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

446

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Computerized counseling about Emergency Contraception
Behavioral: "video doctor," computer module
computerized counseling about emergency contraception and peri-conception folate
Other Names:
  • 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 Names:
  • EC and folate arms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Use of Emergency Contraception
Time Frame: 7 months
7 months
Use of Folate supplements
Time Frame: 7 months
7 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Access to Emergency Contraception at home
Time Frame: 7 months
7 months
Knowledge of emergency contraception
Time Frame: 7 months
7 months
Knowledge of the benefits of folate supplementation
Time Frame: 7 months
7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Collaborators

University of California, San Francisco

Investigators

  • Principal Investigator: Eleanor B Schwarz, MD, University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 15, 2005

Study Record Updates

Last Update Posted (Estimate)

May 5, 2010

Last Update Submitted That Met QC Criteria

May 4, 2010

Last Verified

May 1, 2010

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H2582-25916-01A

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preconception Care

Clinical Trials on "video doctor," computer module

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Romania

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe