- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02234271
Plan A Birth Control: Randomized Controlled Trial of a Mobile Health Application for Contraception Information
September 4, 2014 updated by: UCLA Women's Health Clinical Research Unit, University of California, Los Angeles
The primary objective of the investigators study was to design a comprehensive and medically accurate contraception counseling mobile health application and evaluate the effects of this contraception counseling application on the contraceptive methods that patients selected and their knowledge of that method.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
120
Phase
- Not Applicable
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
-
-
California
-
Los Angeles, California, United States, 90095
- West Medical Clinic
-
-
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
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 18-45 years of age
- literate in English
- not at that time using a contraceptive method
- willing to switch to a new reversible contraceptive method
- currently sexually active with a male partner and
- intending to avoid pregnancy for at least one year
Exclusion Criteria:
- women not at risk for unintended pregnancy
- those who were pregnant
- seeking pregnancy within the next 12 months
- history of surgical sterilization or
- a current partner who had had a vasectomy
- using long acting reversible birth control method
- menopausal
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: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Health Educator Arm
Health Educator for contraception information
|
Counseling via health educator
|
Experimental: Mobile Health Application Arm
Plan A Birth Control - iPad based application for contraception information
|
Mobile Health application for contraception information
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Contraception choice
Time Frame: Participants were followed for the duration of their clinic visit which was up to one day
|
Choice of birth control selected by participant was recorded into electronic database system and compared between the two groups.
|
Participants were followed for the duration of their clinic visit which was up to one day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Knowledge of contraception method chosen
Time Frame: Participants were followed for the duration of their clinic visit which was up to one day
|
A knowledge questionnaire was administered at the end of patient's visit and results were analyzed.
|
Participants were followed for the duration of their clinic visit which was up to one day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Aparna Sridhar, MD, MPH, University of California, Los Angeles
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.
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
September 1, 2012
Primary Completion (Actual)
August 1, 2013
Study Completion (Actual)
August 1, 2013
Study Registration Dates
First Submitted
August 26, 2014
First Submitted That Met QC Criteria
September 4, 2014
First Posted (Estimate)
September 9, 2014
Study Record Updates
Last Update Posted (Estimate)
September 9, 2014
Last Update Submitted That Met QC Criteria
September 4, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Other Study ID Numbers
- UCLA_IRB_14-000821
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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.
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