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Over-the-Counter Medication Usage

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00439348

First Posted: February 23, 2007

Last Update Posted: November 23, 2009

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by:

Florida Hospital

Purpose

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	Intervention
Drugs, Non-Prescription Medication Systems	Behavioral: Verbal advice Behavioral: Prescription


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Single (Participant) Primary Purpose: Treatment
Official Title:	Improving Over-the-counter Medication Compliance.

Resource links provided by NLM:

MedlinePlus related topics: Over-the-Counter Medicines

U.S. FDA Resources

Further study details as provided by Florida Hospital:

Primary Outcome Measures:

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. ]


Enrollment:	246
Study Start Date:	February 2007
Study Completion Date:	February 2009
Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

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.

Eligibility

Information from the National Library of Medicine

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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

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


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 Submitted:	February 21, 2007
First Posted:	February 23, 2007
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

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