Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders

This study has been completed.
Sponsor:
Collaborator:
Anonymous
Information provided by:
Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:
NCT00733707
First received: August 11, 2008
Last updated: October 6, 2010
Last verified: June 2010
  Purpose

The purpose of this study is to determine whether there is increased oral contraceptive pill (OCP) adherence in women receiving daily text messaging reminders to take their OCP, compared to women who do not receive reminders. The investigators hypothesize that women who receive daily text messaging reminders to take their OCP will have increased pill adherence compared to women who do not receive reminders.

The investigators also hope to determine whether there is a difference in OCP adherence as measured by electronic monitoring device and wireless real-time data collection versus traditional patient pill diaries. The investigators hypothesize that electronic monitoring device and wireless real-time data collection will demonstrate lower adherence compared to traditional patient pill diaries.


Condition Intervention
Oral Contraceptive Pill Adherence
Behavioral: Text messaging reminders

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Official Title: Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders

Further study details as provided by Planned Parenthood League of Massachusetts:

Primary Outcome Measures:
  • Average number of missed pills per cycle [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Rate of adherence as recorded by the electronic pill-dispensing device versus the rate of adherence as recorded by patient pill diaries [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: August 2008
Study Completion Date: June 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Text messaging reminders
Behavioral: Text messaging reminders
Subjects in this arm will receive daily text message reminders once per day at the same time each day. Messages will remind the subject to take their oral contraceptive pill.
No Intervention: 2
No text messaging reminder

  Eligibility

Ages Eligible for Study:   14 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Using oral contraceptive pills (OCPs) for less than 1 month, or plan to initiate OCP use at their current visit
  • Be willing to use OCPs that are on formulary for the duration of the study
  • Having a personal mobile phone with text messaging capabilities
  • Proficiency in English or Spanish
  • Agreeing to surveys regarding demographics, pill adherence behavior and its influences
  • If younger than 18, must be accompanied by a parent or legal guardian who can provide informed consent for research participation

Exclusion Criteria:

  • Electing OCPs solely for non-contraceptive benefits only
  • Interest in pregnancy within the next 12 months
  • Inability to give informed consent
  • Planning to move from the local area before study completion, and is unable to return for follow-up and return the electronic pill bottle
  • Planning travel outside the cell phone networks of United States or Canada
  • Being in a situation where receiving text messages to take a birth control pill may endanger the safety of the subject
  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: NCT00733707

Locations
United States, Massachusetts
Planned Parenthood League of Massachusetts
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Planned Parenthood League of Massachusetts
Anonymous
Investigators
Principal Investigator: Jane Doe Planned Parenthood
  More Information

No publications provided by Planned Parenthood League of Massachusetts

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jane Doe, Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier: NCT00733707     History of Changes
Other Study ID Numbers: Grant-806
Study First Received: August 11, 2008
Last Updated: October 6, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Planned Parenthood League of Massachusetts:
adherence
oral contraceptive pills
contraception
text messaging

Additional relevant MeSH terms:
Contraceptive Agents
Contraceptives, Oral
Contraceptives, Oral, Combined
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female

ClinicalTrials.gov processed this record on August 01, 2014