APART Advanced Profiling of Anti-Rheumatic Therapies
|ClinicalTrials.gov Identifier: NCT00378261|
Recruitment Status : Completed
First Posted : September 19, 2006
Last Update Posted : May 19, 2011
|Condition or disease||Intervention/treatment||Phase|
|Arthritis, Rheumatoid||Procedure: Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.||Phase 4|
This is a randomized, multicenter observational study to assess the impact of the EDCS in a rheumatology clinical practice setting on patient satisfaction with patient-physician communication using the Health Tracker electronic data capture system . Patients will be randomly assigned in a 2:1 ratio to the Health Tracker-user or non-user groups, respectively. The primary outcomes of this study will be the impact that information gathered and analyzed by an electronic data capture system has on patient satisfaction with arthritis care and patient physician interactions in clinical practice. Patient satisfaction will be assessed using a questionnaire developed specifically for this study.
This study does not involve the use of any investigational drugs, and the protocol does not mandate the treatment regimen patients will receive. Physicians will prescribe antirheumatic medications in accordance with usual clinical practice. The planned duration of subject participation is 12 months
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1079 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Multicenter, Randomized, Open Study to Evaluate the Impact of an Electronic Data Capture System on the Care of Patients With Rheumatoid Arthritis|
|Study Start Date :||January 2004|
|Actual Study Completion Date :||July 2005|
- Primary endpoints for the Health Tracker-user group are the change in the patient satisfaction and patient-physician interaction surveys between the pre- and post-randomization phases.
- Changes between the pre- and post-randomization phases in the following clinical evaluations: HAQ scores, SF-12 scores, Patient assessed painful and/or swollen joint counts, Health care professional assessed tender and swollen joint counts
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00378261
|Study Director:||Centocor, Inc. Clinical Trial||Centocor, Inc.|