Prescription Methods Assessment Project (PMAP)

This study has been terminated.
(Funding ended early)
Sponsor:
Information provided by:
American Academy of Family Physicians
ClinicalTrials.gov Identifier:
NCT00393653
First received: October 26, 2006
Last updated: May 9, 2011
Last verified: May 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Publications:
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 August 28, 2014