Drugs, Non-PrescriptionNCT00439348
Over-the-Counter Medication Usage
A study testing Verbal advice and Prescription in people with Drugs, Non-Prescription and Medication Systems, run by AdventHealth at 1 site in United States.
Trial summary
There are several benefits of over-the-counter medications, yet there is little research evaluating how to increase patient compliance when a health care provider suggests an over-the-counter (OTC) medication. Read more about this study
- Who is it for?
- Ages 19 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drugs, Non-Prescription, Medication Systems
- What is being tested?
- Verbal advice and Prescription
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 246 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Feb 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 19 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients undergoing annual gynecologic examinations.
- Ages 19-50.
- Patients not currently taking certain OTC medications.
Who cannot join
- Pregnancy.
- History of hypercalcemia.
- History of kidney stones.
- Outside study age range of 19-50.
- Patient taking thyroid medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Improving Over-the-counter Medication Compliance.
There are several benefits of over-the-counter medications, yet there is little research evaluating how to increase patient compliance when a health care provider suggests an over-the-counter (OTC) medication. We are evaluating two types of physician directions to see which increases patient compliance with OTC medications.
Read the detailed description
Researchers will identify a cohort of gynecologic patients presenting for annual examinations and offer participation in the study. Physician researchers will randomize patients to 2 types of physician directions about OTC medications, then follow compliance over the course of the next 7 months. A total of 123 participants in each arm will undergo recruitment, until a total of 246 participants are recruited.
Inclusion criteria include: female, non-pregnant patients presenting for annual gynecologic examinations between the ages of 19-50.
Exclusion criteria include: outside of study age range, patient taking thyroid medication, history of kidney stones, history of hypercalcemia, non-English speaking.
- Conditions
- Drugs, Non-Prescription, Medication Systems
- Being tested
- Verbal advice, Prescription
- Keywords
- Calcium, Compliance, Medication compliance, electronic prescription, over-the-counter medications, OTC medications
- Medical subject headings
- Patient Compliance, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Verbal adviceBehavioural
Patients receive verbal advice regarding specific over-the-counter medications.
PrescriptionBehavioural
Patients receive a prescription for a specific over-the-counter medication.
| Study group | Role | What they receive |
|---|---|---|
| Electronic prescription | Experimental | Patients receive a prescription for specific over-the-counter medications. Receives: Behavioral: Prescription |
| Verbal advice | Active comparator | Not described Receives: Behavioral: Verbal advice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determining which of 2 types of physician direction regarding OTC medication usage improves patients compliance, as assessed at 3 and 6 months after enrollment.
Measured: 3 and 6 months after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionNov 2008
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drugs, Non-PrescriptionStudies 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
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 246 participants (actual)
Sponsor and investigators
- Lead sponsor
- AdventHealth
- Sponsor type
- University, hospital or other
- Investigators
- D. A Hill, MD, Study chair, Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00439348
- Sponsor's protocol ID
- 07.02.01
- Status last verified
- Nov 2009
- First submitted
- 21 Feb 2007
- Last updated
- 23 Nov 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Over-the-counter Medication Compliance.
- ClinicalTrials.gov ID
- NCT00439348
- Acronym / sponsor ID
- 07.02.01
- Conditions
- Drugs, Non-Prescription, Medication Systems
- Keywords
- Calcium, Compliance, Medication compliance, electronic prescription, over-the-counter medications, OTC medications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 246 participants (actual)
- Lead sponsor
- AdventHealthUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Nov 2008 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 23 Feb 2007 (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.
There are several benefits of over-the-counter medications, yet there is little research evaluating how to increase patient compliance when a health care provider suggests an over-the-counter (OTC) medication. We are evaluating two types of physician directions to see which increases patient compliance with OTC medications.
Detailed description
Researchers will identify a cohort of gynecologic patients presenting for annual examinations and offer participation in the study. Physician researchers will randomize patients to 2 types of physician directions about OTC medications, then follow compliance over the course of the next 7 months. A total of 123 participants in each arm will undergo recruitment, until a total of 246 participants are recruited.
Inclusion criteria include: female, non-pregnant patients presenting for annual gynecologic examinations between the ages of 19-50.
Exclusion criteria include: outside of study age range, patient taking thyroid medication, history of kidney stones, history of hypercalcemia, non-English speaking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Electronic prescription | Experimental | Behavioral: PrescriptionPatients receive a prescription for specific over-the-counter medications. |
| Verbal advice | Active comparator | Behavioral: Verbal advice |
Who may qualify
- Ages
- 19 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients undergoing annual gynecologic examinations.
- Ages 19-50.
- Patients not currently taking certain OTC medications.
Key exclusion criteria (5 listed)
- Pregnancy.
- History of hypercalcemia.
- History of kidney stones.
- Outside study age range of 19-50.
- Patient taking thyroid medication.
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 |
|---|---|---|
| Verbal advicePatients receive verbal advice regarding specific over-the-counter medications. | Behavioural | Verbal advice |
| PrescriptionPatients receive a prescription for a specific over-the-counter medication. | Behavioural | Electronic prescription |
Primary outcome
Determining which of 2 types of physician direction regarding OTC medication usage improves patients compliance, as assessed at 3 and 6 months after enrollment.
Time frame: 3 and 6 months after enrollment.
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 23 Nov 2009.
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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.
D. A Hill, MD study chair
Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Verbal advice and Prescription in people with Drugs, Non-Prescription and Medication Systems, run by AdventHealth 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 3 inclusion and 5 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 23 Nov 2009. 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?
Determining which of 2 types of physician direction regarding OTC medication usage improves patients compliance, as assessed at 3 and 6 months after enrollment. (time frame: 3 and 6 months after enrollment.). 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 23 Nov 2009.