Preconception CarePhase 3NCT00177515
Computer-assisted Preventive Health Education for Women of Reproductive Age in Urgent Care Settings
A Phase 3 study testing "video doctor," computer module in people with Preconception Care, run by University of Pittsburgh at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preconception Care
- What is being tested?
- "video doctor," computer module
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2005to Jan 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 18-45 year old English-speaking women
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: 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.
Read the 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.
- Conditions
- Preconception Care
- Being tested
- "video doctor," computer module
- Keywords
- emergency contraception, folic acid, education, preventive health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"video doctor," computer moduleBehavioural
Also called EC and folate arms
computerized counseling about emergency contraception and peri-conception folate
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Computerized counseling about Emergency Contraception Receives: Behavioral: "video doctor," computer module |
| 2 | Active comparator | Computerized counseling about peri-conception folate Receives: Behavioral: "video doctor," computer module |
What is being measured
The primary outcome is the main question the study is designed to answer.
Use of Emergency Contraception
Measured: 7 months
Use of Folate supplements
Measured: 7 months
Secondary outcomes (3)
Access to Emergency Contraception at home
Measured: 7 months
Knowledge of emergency contraception
Measured: 7 months
Knowledge of the benefits of folate supplementation
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startMar 2005
- Primary completionDec 2006
- Study completionJan 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Preconception CareStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Francisco
- Investigators
- Eleanor B Schwarz, MD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00177515
- Sponsor's protocol ID
- H2582-25916-01A
- Status last verified
- May 2010
- First submitted
- 13 Sep 2005
- Last updated
- 5 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Schwarz EB, Gerbert B, Gonzales R. Computer-assisted provision of emergency contraception a randomized controlled trial. J Gen Intern Med. 2008 Jun;23(6):794-9. doi: 10.1007/s11606-008-0609-x. Epub 2008 Apr 9.
PubMed 18398664Schwarz EB, Sobota M, Gonzales R, Gerbert B. Computerized counseling for folate knowledge and use: a randomized controlled trial. Am J Prev Med. 2008 Dec;35(6):568-71. doi: 10.1016/j.amepre.2008.06.034.
PubMed 19000845
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventive Health Education for Women of Reproductive Age
- ClinicalTrials.gov ID
- NCT00177515
- Acronym / sponsor ID
- H2582-25916-01A
- Conditions
- Preconception Care
- Keywords
- emergency contraception, folic acid, education, preventive health
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 446 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- University of California, San Francisco
- Study start
- Mar 2005
- Primary completion
- Dec 2006 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: "video doctor," computer moduleComputerized counseling about Emergency Contraception |
| 2 | Active comparator | Behavioral: "video doctor," computer moduleComputerized counseling about peri-conception folate |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 18-45 year old English-speaking women
Key exclusion criteria (6 listed)
- current pregnancy
- history of tubal ligation
- hysterectomy
- partner with a vasectomy
- no sex with men
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| "video doctor," computer moduleAlso: EC and folate armscomputerized counseling about emergency contraception and peri-conception folate | Behavioural | 1, 2 |
Primary outcome
Use of Emergency Contraception
Time frame: 7 months
Use of Folate supplements
Time frame: 7 months
3 secondary outcomes
Access to Emergency Contraception at home
Time frame: 7 months
Knowledge of emergency contraception
Time frame: 7 months
Knowledge of the benefits of folate supplementation
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2010.
- Results publication: PubMed 18398664Schwarz EB, Gerbert B, Gonzales R. Computer-assisted provision of emergency contraception a randomized controlled trial. J Gen Intern Med. 2008 Jun;23(6):794-9. doi: 10.1007/s11606-008-0609-x. Epub 2008 Apr 9.
- Derived from this study: PubMed 19000845Schwarz EB, Sobota M, Gonzales R, Gerbert B. Computerized counseling for folate knowledge and use: a randomized controlled trial. Am J Prev Med. 2008 Dec;35(6):568-71. doi: 10.1016/j.amepre.2008.06.034.
- Computerized Counseling for Folate Knowledge and UseLink provided by the sponsor.
Related trials for Preconception Care
Active, not recruiting
Healthy for my Baby- RCT of a Lifestyle Intervention for Overweight Women in Preconception
Overweight and Obesity, Pregnancy Complications
Active, not recruiting
Promoting Preconception Care and Diabetes Self-Management Among Reproductive-Aged Women With Diabetes
Diabetes Mellitus, Type 2, Electronic Health Record
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Group Preconception Care for Fertility Patients
Infertility
Recruiting
Improving Alcohol and Substance Use Care Access, Outcome, Equity During the Reproductive Years
Alcohol-Related Disorders, Substance-Related Disorders
Not yet recruiting
Lifestyle, Education, Activity, Nutrition (LEAN) Into Pregnancy
Pregnancy, Preconception Education
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eleanor B Schwarz, MD principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing "video doctor," computer module in people with Preconception Care, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Use of Emergency Contraception (time frame: 7 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00177515, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2010.