Trial record 8 of 10 for:    Open Studies | "Pregnancy in Adolescence"

A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Columbia University
Sponsor:
Collaborator:
Society of Family Planning
Information provided by (Responsible Party):
Lauren S. Chernick, Columbia University
ClinicalTrials.gov Identifier:
NCT02093884
First received: March 19, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

The objective of this study is to develop and test an emergency department (ED)-based intervention which uses text messages to facilitate contraception initiation. 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.


Condition Intervention
Pregnancy
Other: Text Messaging Intervention
Other: Standard Referral

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Texting 2 Initiate: A Pilot Study Using Text Messaging to Communicate With Adolescent Females in the Pediatric Emergency Department (T2I)

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Initiation of highly effective contraception, as defined by the World Health Organization. [ Time Frame: 3 months after initial enrollment ] [ Designated as safety issue: No ]
    We will be assessing contraception initiation rates based on electronic medical record review and telephone call follow up.


Secondary Outcome Measures:
  • Patient visits to Family Planning Clinic [ Time Frame: 3 months after initial enrollment ] [ Designated as safety issue: No ]
    We assess Family Planning Clinic visits using our electronic medical records.

  • Follow up for contraceptive counseling to a doctor or nurse [ Time Frame: 3 months after initial enrollment ] [ Designated as safety issue: No ]
    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.

  • Change in pregnancy intentions [ Time Frame: 3 months after initial enrollment ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Text messaging intervention safety [ Time Frame: 3 months after initial enrollment ] [ Designated as safety issue: Yes ]
    Safety will be assessed during the telephone follow up.


Estimated Enrollment: 100
Study Start Date: January 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Text Messaging Intervention
Patients in the text messaging group will receive educational and motivational text messages.
Other: Text Messaging Intervention
Active Comparator: Standard Referral
Patients in the standard referral arm will receive paper based information about the Family Planning Clinic.
Other: Standard Referral

  Eligibility

Ages Eligible for Study:   14 Years to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT02093884

Contacts
Contact: Lauren S Chernick, MD lc2243@cumc.columbia.edu
Contact: Mayra Duarte 212-305-9825

Locations
United States, New York
Morgan Stanley Children's Hospital Emergency Department Recruiting
Manhattan, New York, United States, 10032
Contact: Michael DeGuzman, MPH    212-305-3381    mad2245@cumc.columbia.edu   
Principal Investigator: Lauren S Chernick, MD         
Sponsors and Collaborators
Columbia University
Society of Family Planning
Investigators
Principal Investigator: Lauren Chernick, MD Columbia University
  More Information

No publications provided

Responsible Party: Lauren S. Chernick, Assistant Professor of Pediatrics, Columbia University
ClinicalTrials.gov Identifier: NCT02093884     History of Changes
Other Study ID Numbers: AAAM3457
Study First Received: March 19, 2014
Last Updated: March 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
Pregnancy
Pregnancy, unplanned
Reproductive behavior
Pregnancy in Adolescence
Text messaging

ClinicalTrials.gov processed this record on October 01, 2014