NCT00439348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
246

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

November 23, 2009

Status Verified

November 1, 2009

Enrollment Period

1.8 years

First QC Date

February 21, 2007

Last Update Submit

November 20, 2009

Conditions

Drugs, Non-PrescriptionMedication Systems

Keywords

CalciumComplianceMedication complianceelectronic prescriptionover-the-counter medicationsOTC medications

Outcome Measures

Primary Outcomes (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.

    3 and 6 months after enrollment.

Study Arms (2)

Electronic prescription

EXPERIMENTAL

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

Behavioral: Prescription

Verbal advice

ACTIVE COMPARATOR
Behavioral: Verbal advice

Interventions

Verbal adviceBEHAVIORAL

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

Verbal advice
PrescriptionBEHAVIORAL

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

Electronic prescription

Eligibility Criteria

Age19 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Pregnancy.
  • History of hypercalcemia.
  • History of kidney stones.
  • Outside study age range of 19-50.
  • Patient taking thyroid medication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loch Haven Ob/Gyn Group

Orlando, Florida, 32804, United States

Location

MeSH Terms

Conditions

Patient ComplianceMedication Adherence

Interventions

Prescriptions

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Pharmaceutical ServicesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • D. A Hill, MD

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

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 21, 2007

First Posted

February 23, 2007

Study Start

February 1, 2007

Primary Completion

November 1, 2008

Study Completion

February 1, 2009

Last Updated

November 23, 2009

Record last verified: 2009-11

Locations

US(1)