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Over-the-Counter Medication Usage

NCT ID: NCT00439348

Last Updated: 2009-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

246 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-02-28

Brief Summary

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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

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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

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Drugs, Non-Prescription Medication Systems

Keywords

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Calcium Compliance Medication compliance electronic prescription over-the-counter medications OTC medications

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Electronic prescription

Patients receive a prescription for specific over-the-counter medications.

Group Type EXPERIMENTAL

Prescription

Intervention Type BEHAVIORAL

Patients receive a prescription for a specific over-the-counter medication.

Verbal advice

Group Type ACTIVE_COMPARATOR

Verbal advice

Intervention Type BEHAVIORAL

Patients receive verbal advice regarding specific over-the-counter medications.

Interventions

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Verbal advice

Patients receive verbal advice regarding specific over-the-counter medications.

Intervention Type BEHAVIORAL

Prescription

Patients receive a prescription for a specific over-the-counter medication.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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AdventHealth

OTHER

Sponsor Role lead

Responsible Party

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Florida Hospital Department of Obstetrics and Gynecology

Principal Investigators

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D. A Hill, MD

Role: STUDY_CHAIR

Department of Obstetrics and Gynecology, Florida Hospital Family Medicine Residency Program

Locations

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Loch Haven Ob/Gyn Group

Orlando, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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07.02.01

Identifier Type: -

Identifier Source: org_study_id