Adherence to Oral Contraceptive TherapyNCT01947842
Effect of a Smartphone Application on Oral Contraceptive Adherence in College Females
A study testing Smartphone App Dosecast in people with Adherence to Oral Contraceptive Therapy, run by Belmont University at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 29 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adherence to Oral Contraceptive Therapy
- What is being tested?
- Smartphone App Dosecast
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 3 sitesUnited States
- Study dates
- Jan 2014to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Auburn University
Auburn, Alabama, 36849
Belmont University
Nashville, Tennessee, 37212
University of Mississippi
Oxford, Mississippi, 38677
About this study
Official title: 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.
- Conditions
- Adherence to Oral Contraceptive Therapy
- Being tested
- Smartphone App Dosecast
- Keywords
- Smartphone, adherence, contraceptives, college, females
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone App DosecastDevice
The Dosecast app is configured to remind the patient to take their medication.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Smartphone App Dosecast |
| Counseling Alone | No intervention | This arm will receive only counseling from the pharmacist with no other intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Doses Missed
Number of doses of oral contraceptive missed over a six-month period.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014
Why it stopped: Funding unavailable.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adherence to Oral Contraceptive TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Belmont University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Adam Pace, Belmont University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01947842
- Sponsor's protocol ID
- BUCOP-001
- Status last verified
- Feb 2023
- First submitted
- 18 Sep 2013
- Last updated
- 15 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Smartphone Application on Oral Contraceptive Adherence in College Females: a Randomized-controlled Trial.
- ClinicalTrials.gov ID
- NCT01947842
- Acronym / sponsor ID
- BUCOP-001
- Conditions
- Adherence to Oral Contraceptive Therapy
- Keywords
- Smartphone, adherence, contraceptives, college, females
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding unavailable.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Belmont UniversityUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone App | Experimental | Device: Smartphone App DosecastThe 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. |
| Counseling Alone | No intervention | –This arm will receive only counseling from the pharmacist with no other intervention. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone App DosecastThe Dosecast app is configured to remind the patient to take their medication. | Device | Smartphone App |
Primary outcome
Doses Missed
Time frame: 6 months
Number of doses of oral contraceptive missed over a six-month period.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone App Dosecast in people with Adherence to Oral Contraceptive Therapy, run by Belmont University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 15 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Doses Missed (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2023.