NCT01947842

Brief Summary

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

3 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 18, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 23, 2013

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

11 months

First QC Date

September 18, 2013

Last Update Submit

February 13, 2023

Conditions

Adherence to Oral Contraceptive Therapy

Keywords

Smartphoneadherencecontraceptivescollegefemales

Outcome Measures

Primary Outcomes (1)

  • Doses Missed

    Number of doses of oral contraceptive missed over a six-month period.

    6 months

Study Arms (2)

Smartphone App

EXPERIMENTAL

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

Counseling Alone

NO INTERVENTION

This arm will receive only counseling from the pharmacist with no other intervention.

Interventions

Smartphone App DosecastDEVICE

The Dosecast app is configured to remind the patient to take their medication.

Smartphone App

Eligibility Criteria

Age18 Years - 29 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • female gender
  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Auburn University

Auburn, Alabama, 36849, United States

Location

University of Mississippi

Oxford, Mississippi, 38677, United States

Location

Belmont University

Nashville, Tennessee, 37212, United States

Location
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Pharmacy Practice

Study Record Dates

First Submitted

September 18, 2013

First Posted

September 23, 2013

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

US(3)