NCT00378261

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,079

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Jan 2004

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

September 15, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 19, 2006

Completed
Last Updated

May 19, 2011

Status Verified

April 1, 2010

First QC Date

September 15, 2006

Last Update Submit

May 18, 2011

Conditions

Arthritis, Rheumatoid

Keywords

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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.

Secondary Outcomes (1)

  • 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

Interventions

Use of an Electronic Data Capture System by patients and physicians to assess patient-physician interactions & therapeutic decisions & outcomes in RA subjects.PROCEDURE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed with active rheumatoid arthritis according to the revised criteria of the ACR (1987)
  • Have rheumatoid arthritis that requires regularly scheduled visits with their rheumatologist at least every 3 months
  • Willing and able to adhere to protocol requirements and participate in a study, lasting 12 months

You may not qualify if:

  • Patients currently receiving investigational drugs
  • Currently participating in other clinical trials or safety registries for rheumatoid arthritis or rheumatoid arthritis -related therapies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Treatment Outcome

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PrognosisDiagnosisOutcome Assessment, Health CareOutcome and Process Assessment, Health CareQuality of Health CareHealth Services AdministrationHealth Care Evaluation MechanismsHealth Care Quality, Access, and Evaluation

Study Officials

  • Centocor, Inc. Clinical Trial

    Centocor, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 15, 2006

First Posted

September 19, 2006

Study Start

January 1, 2004

Study Completion

July 1, 2005

Last Updated

May 19, 2011

Record last verified: 2010-04