Prescription Methods Assessment Project (PMAP)

NCT00393653 | Terminated

• 1 other identifier: 06-016
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Osteoarthritis; Gastroesophageal Reflux Disease

Keywords

osteoarthritis; gastroesophageal reflux disease; practice-based research; N-of-1 trial; prescription; single-patient trial

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (2)

• 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

Interventions

N-of-1 prescription method PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• American Academy of Family Physicians: lead

Study Sites (1)

American Academy of Family Physicians National Research Network

Leawood, Kansas, 66211, United States

Location

Related Publications (2)

• 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. doi: 10.18553/jmcp.2002.8.6.459.

  PMID: 14613380 BACKGROUND

• 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. doi: 10.1345/aph.1C031.

  PMID: 12196053 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Wilson D Pace, MD

  American Academy of Family Physicians

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 26, 2006
• First Posted: October 30, 2006
• Study Start: October 1, 2006
• Study Completion: May 1, 2007
• Last Updated: May 10, 2011

Record last verified: 2011-05

Locations

US (1)