Effect of a Smartphone Application on Oral Contraceptive... | NCT01947842

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

NCT01947842

Sponsor

Belmont University

Status

Withdrawn

Last Update Posted

Feb 15, 2023Actual

Enrollment

0Actual

Phase

Not Applicable

Conditions

Adherence to Oral Contraceptive Therapy

Interventions

Smartphone App Dosecast

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Funding unavailable.

Expanded Access Info

Start Date

Jan 2014

Primary Completion Date

Dec 2014Estimated

Completion Date

Dec 2014Actual

First Submitted Date

Sep 18, 2013

First Submission Date that Met QC Criteria

Sep 20, 2013

First Posted Date

Sep 23, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 13, 2023

Last Update Posted Date

Feb 15, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Smartphone App Dosecast	Device	The Dosecast app is configured to remind the patient to take their medication.	Smartphone App

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

29 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Auburn University		Auburn	Alabama	36849	United States
University of Mississippi