- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02093884
A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
January 18, 2017 updated by: Lauren S. Chernick, Columbia University
Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)
The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Our hypothesis is that adolescent females at high pregnancy risk who receive text message reminders and motivational messages that promote contraception and referral to the Family Planning Clinic are more likely to start effective contraception than those who receive standard paper-based referral to the Family Planning Clinic alone.
Study Type
Interventional
Enrollment (Actual)
100
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
-
-
New York
-
Manhattan, New York, United States, 10032
- Morgan Stanley Children's Hospital Emergency Department
-
-
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
14 years to 19 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Aged 14-19 years
- Sexually active with males in the past three months
- Presenting to the ED for a reproductive health complaint.
Exclusion Criteria:
- Presently pregnant
- Too ill for participation per the attending physician
- Cognitively impaired
- In foster care or a ward of the state
- Does not speak English or Spanish
- Does not own a cellular or mobile phone with text messaging capabilities
- Used contraception at last intercourse and/or is currently using any "highly effective" or "effective" form of contraception (as defined by the World Health Organization)
- Does not live in Manhattan or the Bronx
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Text Messaging Intervention
Patients in the text messaging group will receive educational and motivational text messages.
|
|
Active Comparator: Standard Referral
Patients in the standard referral arm will receive paper based information about the Family Planning Clinic.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Initiation of highly effective contraception, as defined by the World Health Organization.
Time Frame: 3 months after initial enrollment
|
We will be assessing contraception initiation rates based on electronic medical record review and telephone call follow up.
|
3 months after initial enrollment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Patient visits to Family Planning Clinic
Time Frame: 3 months after initial enrollment
|
We assess Family Planning Clinic visits using our electronic medical records.
|
3 months after initial enrollment
|
Follow up for contraceptive counseling to a doctor or nurse
Time Frame: 3 months after initial enrollment
|
We will be asking patients during our phone call follow if they have had contraceptive counseling with any healthcare professional.
We will also be looking through electronic medical records for documentation of contraceptive counseling such as by ICD-9 coding or a physician's/nurse's note.
|
3 months after initial enrollment
|
Change in pregnancy intentions
Time Frame: 3 months after initial enrollment
|
We will compare pregnancy intentions elicited from the answers provided in the baseline questionnaire to those reported on the telephone follow up for both study arms.
|
3 months after initial enrollment
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Text messaging intervention safety
Time Frame: 3 months after initial enrollment
|
Safety will be assessed during the telephone follow up.
|
3 months after initial enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lauren Chernick, MD, Columbia University
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 (Actual)
January 1, 2014
Primary Completion (Actual)
March 1, 2015
Study Completion (Actual)
March 1, 2015
Study Registration Dates
First Submitted
March 19, 2014
First Submitted That Met QC Criteria
March 19, 2014
First Posted (Estimate)
March 21, 2014
Study Record Updates
Last Update Posted (Estimate)
January 20, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- AAAM3457
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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