Effect of a Smartphone Application on Oral Contraceptive Adherence in College Females

February 13, 2023 updated by: Adam Pace, Belmont University

Effect of a Smartphone Application on Oral Contraceptive Adherence in College Females: a Randomized-controlled Trial.

This research study is to see if smartphone applications help college women remember to take birth control better than pharmacist consultation alone. Patients will participate in this study for 6 (six) months. The study will have two groups. Patients will be randomly assigned to one group or the other. The control group will be counseled by the pharmacist on the importance of taking birth control as prescribed. The study group will get the same counseling, but will also be set up to receive reminders to take medication on a smartphone application called Dosecast.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

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

  • United States
    • Alabama
      • Auburn, Alabama, United States, 36849
        • Auburn University
    • Mississippi
      • Oxford, Mississippi, United States, 38677
        • University of Mississippi
    • Tennessee
      • Nashville, Tennessee, United States, 37212
        • Belmont University

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 29 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • female gender
  • 18-29 years of age
  • current prescription for an OCP
  • currently enrolled as a student at the institution associated with the pharmacy
  • possession of a compatible smartphone.

Exclusion Criteria:

  • Pregnant patients
  • Patients who become pregnant during the study will discontinue, but their data up until time of discontinuation will be used
  • Patients using other forms of contraception (patch, injection, IUD, intra-vaginal ring, implant).

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Smartphone App
The pharmacist will download and configure the Dosecast smartphone application to remind the patient to take their medication in addition to pharmacist counseling on the importance of adherence.
Device: Smartphone App Dosecast
The Dosecast app is configured to remind the patient to take their medication.
No Intervention: Counseling Alone
This arm will receive only counseling from the pharmacist with no other intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doses Missed
Time Frame: 6 months
Number of doses of oral contraceptive missed over a six-month period.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Belmont University

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

January 1, 2014

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

September 18, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimate)

September 23, 2013

Study Record Updates

Last Update Posted (Actual)

February 15, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • BUCOP-001

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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