Prescription Methods Assessment Project (PMAP)

This study has been terminated.

( Funding ended early )

First Received on October 26, 2006. Last Updated on May 9, 2011 History of Changes

Sponsor:	American Academy of Family Physicians
Information provided by:	American Academy of Family Physicians
ClinicalTrials.gov Identifier:	NCT00393653

Purpose

The purpose of this study is to evaluate whether a novel prescription method (N-of-1 intervention)can be successfully integrated into primary care practices and to examine the effects of this prescription method on selected patient health outcomes (e.g.., medication compliance, medication costs, symptom management, satisfaction of physician/patient visit, etc.) in patients with a uncontrolled or new diagnosis of Osteoarthritis or Chronic Heartburn (GERD).

Condition	Intervention
Osteoarthritis Gastroesophageal Reflux Disease	Procedure: N-of-1 prescription method

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Prescription Methods Assessment Project (PMAP)

Resource links provided by NLM:

MedlinePlus related topics: GERD Osteoarthritis

U.S. FDA Resources

Further study details as provided by American Academy of Family Physicians:

Primary Outcome Measures:

Side-effects and adverse events (base-line, 3 and 6 months)

Secondary Outcome Measures:

Symptoms of condition and health related issues (i.e., satisfaction of doctor visit, self-efficacy)at baseline, 3 and 6 months
Patient medication information and adherence to prescription(s) at 3 and 6 months

Estimated Enrollment:	800
Study Start Date:	October 2006
Study Completion Date:	May 2007

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

at least 18 years old
capable of giving informed consent
a new diagnosis or uncontrolled symptoms of either osteoarthritis or gastroesophageal reflux disease
if new diagnosis or uncontrolled osteoarthritis, patient must have condition in knee or hip (need not be isolated)

Exclusion Criteria:

too ill to participate
not capable of giving informed consent
not able to be contacted via phone for study follow-up
unable to read English, including blindness
if treating physician considers patient to have medical conditions that would cause the patient to be placed at risk by trial participation

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00393653

Locations

United States, Kansas
American Academy of Family Physicians National Research Network
Leawood, Kansas, United States, 66211

Sponsors and Collaborators

American Academy of Family Physicians

Investigators

Principal Investigator:

Wilson D Pace, MD

American Academy of Family Physicians

More Information

Additional Information:

American Academy of Family Physicians National Research Network Homepage This link exits the ClinicalTrials.gov site

Publications:

Wolfe B, Del Rio E, Weiss SL, Mendelson A, Elbaga TA, Huser FJ, Reitberg DP. Validation of a single-patient drug trial methodology for personalized management of gastroesophageal reflux disease. J Manag Care Pharm. 2002 Nov-Dec;8(6):459-68.

Reitberg DP, Del Rio E, Weiss SL, Rebell G, Zaias N. Single-patient drug trial methodology for allergic rhinitis. Ann Pharmacother. 2002 Sep;36(9):1366-74.

ClinicalTrials.gov Identifier:	NCT00393653 History of Changes
Other Study ID Numbers:	06-016
Study First Received:	October 26, 2006
Last Updated:	May 9, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by American Academy of Family Physicians:

osteoarthritis
gastroesophageal reflux disease
practice-based research

N-of-1 trial
prescription
single-patient trial

Additional relevant MeSH terms:

Gastroesophageal Reflux
Osteoarthritis
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases

Digestive System Diseases
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on February 09, 2012