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Over-the-Counter Medication Usage

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ClinicalTrials.gov Identifier: NCT00439348
Recruitment Status : Completed
First Posted : February 23, 2007
Last Update Posted : November 23, 2009
Sponsor:
Information provided by:
Florida Hospital

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief 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. We are evaluating two types of physician directions to see which increases patient compliance with OTC medications.

Condition or disease Intervention/treatment Phase
Drugs, Non-Prescription Medication Systems Behavioral: Verbal advice Behavioral: Prescription Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 246 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Improving Over-the-counter Medication Compliance.
Study Start Date : February 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : February 2009

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U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
Experimental: Electronic prescription
Patients receive a prescription for specific over-the-counter medications.
 Behavioral: Prescription
Patients receive a prescription for a specific over-the-counter medication.
Active Comparator: Verbal advice Behavioral: Verbal advice
Patients receive verbal advice regarding specific over-the-counter medications.


Outcome Measures
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Primary Outcome Measures :
  1. 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. ]

Eligibility Criteria
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Ages Eligible for Study:   19 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Female patients undergoing annual gynecologic examinations.
  • Ages 19-50.
  • Patients not currently taking certain OTC medications.

Exclusion Criteria:

  • Pregnancy.
  • History of hypercalcemia.
  • History of kidney stones.
  • Outside study age range of 19-50.
  • Patient taking thyroid medication.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00439348


Locations
United States, Florida
Loch Haven Ob/Gyn Group
Orlando, Florida, United States, 32804
Sponsors and Collaborators
Florida Hospital
Investigators
Study Chair: D. A Hill, MD Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: D. Ashley Hill, M.D., Florida Hospital Department of Obstetrics and Gynecology
ClinicalTrials.gov Identifier: NCT00439348     History of Changes
Other Study ID Numbers: 07.02.01
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: November 23, 2009
Last Verified: November 2009

Keywords provided by Florida Hospital:
Calcium
Compliance
Medication compliance
 electronic prescription
over-the-counter medications
OTC medications