Oral Contraceptive Pill AdherenceNCT00733707
Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
A study testing Text messaging reminders in people with Oral Contraceptive Pill Adherence, run by Planned Parenthood League of Massachusetts at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Oral Contraceptive Pill Adherence
- What is being tested?
- Text messaging reminders
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Jun 2009
- 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 14 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Planned Parenthood League of Massachusetts
Boston, Massachusetts, 02215
About this study
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.
- Conditions
- Oral Contraceptive Pill Adherence
- Being tested
- Text messaging reminders
- Keywords
- adherence, oral contraceptive pills, contraception, text messaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text messaging remindersBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Text messaging reminders Receives: Behavioral: Text messaging reminders |
| 2 | No intervention | No text messaging reminder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average number of missed pills per cycle
Measured: 3 months
Secondary outcomes (1)
Rate of adherence as recorded by the electronic pill-dispensing device versus the rate of adherence as recorded by patient pill diaries
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2008 (estimated)
- Study startAug 2008
- Primary completionMay 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral Contraceptive Pill AdherenceStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Planned Parenthood League of Massachusetts
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane Doe, Principal investigator, Planned Parenthood
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00733707
- Sponsor's protocol ID
- Grant-806
- Status last verified
- Mar 2016
- First submitted
- 11 Aug 2008
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hou MY, Hurwitz S, Kavanagh E, Fortin J, Goldberg AB. Using daily text-message reminders to improve adherence with oral contraceptives: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):633-640. doi: 10.1097/AOG.0b013e3181eb6b0f.
PubMed 20733446
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Adherence With Oral Contraceptives Using Daily Text Messaging Reminders
- ClinicalTrials.gov ID
- NCT00733707
- Acronym / sponsor ID
- Grant-806
- Conditions
- Oral Contraceptive Pill Adherence
- Keywords
- adherence, oral contraceptive pills, contraception, text messaging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Planned Parenthood League of MassachusettsUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- May 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 13 Aug 2008 (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.
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.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Text messaging remindersText messaging reminders |
| 2 | No intervention | –No text messaging reminder |
Who may qualify
- Ages
- 14 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Text messaging remindersSubjects 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. | Behavioural | 1 |
Primary outcome
Average number of missed pills per cycle
Time frame: 3 months
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
- Derived from this study: PubMed 20733446Hou MY, Hurwitz S, Kavanagh E, Fortin J, Goldberg AB. Using daily text-message reminders to improve adherence with oral contraceptives: a randomized controlled trial. Obstet Gynecol. 2010 Sep;116(3):633-640. doi: 10.1097/AOG.0b013e3181eb6b0f.
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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.
Jane Doe principal investigator
Planned Parenthood
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Text messaging reminders in people with Oral Contraceptive Pill Adherence, run by Planned Parenthood League of Massachusetts at 1 site 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 6 inclusion and 6 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: finished, as of the sponsor's last update on 18 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average number of missed pills per cycle (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00733707, which also lists 1 linked publication.
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 18 Mar 2016.