Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders

This study is ongoing, but not recruiting participants.

First Received: August 11, 2008 Last Updated: April 13, 2009 History of Changes

Sponsors and Collaborators:	Planned Parenthood League of Massachusetts An anonymous Foundation.
Information provided by:	Planned Parenthood League of Massachusetts
ClinicalTrials.gov Identifier:	NCT00733707

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

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Investigator), Parallel Assignment
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 ]

Estimated Enrollment:	82
Study Start Date:	August 2008
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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.
2: No Intervention 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

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

An anonymous Foundation.

Investigators

Principal Investigator:

Jane Doe

Planned Parenthood

More Information

No publications provided

Responsible Party:	Planned Parenthood League of Massachusetts ( Jane Doe )
Study ID Numbers:	Grant-806
Study First Received:	August 11, 2008
Last Updated:	April 13, 2009
ClinicalTrials.gov Identifier:	NCT00733707 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Planned Parenthood League of Massachusetts:

adherence
oral contraceptive pills
contraception
text messaging

Study placed in the following topic categories:

Contraceptive Agents
Contraceptives, Oral
Contraceptive Agents, Female

Additional relevant MeSH terms:

Contraceptive Agents
Therapeutic Uses
Physiological Effects of Drugs
Contraceptives, Oral

Contraceptive Agents, Female
Reproductive Control Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009