Ignite Creation Date:
2025-12-24 @ 12:37 PM
Ignite Modification Date:
2025-12-28 @ 7:24 PM
Study NCT ID:
NCT00378261
Status:
COMPLETED
Last Update Posted:
2011-05-19
First Post:
2006-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
APART Advanced Profiling of Anti-Rheumatic Therapies
Sponsor:
Centocor Ortho Biotech Services, L.L.C.
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2010-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the utility of an electronic data capture system (EDCS) in a rheumatology clinical practice setting and to assess the impact of this system on patient satisfaction with patient-physician interaction.
Detailed Description:
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
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: