NCT01721200

Brief Summary

This study is a randomized controlled trial designed to examine the efficacy of an educational decision support tool for patients with rheumatoid arthritis who continue to have active disease despite use of traditional disease modifying drugs. The study will take place at Geisinger Medical Center in Danville, PA. Eligible subjects will be identified by the treating physician and those providing consent will be randomized to usual care versus use of the decision support tool.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Nov 2012

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

October 10, 2012

Completed
22 days until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 5, 2012

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

February 19, 2018

Completed
Last Updated

February 19, 2018

Status Verified

February 1, 2018

Enrollment Period

2.3 years

First QC Date

October 10, 2012

Results QC Date

February 15, 2016

Last Update Submit

February 16, 2018

Conditions

Rheumatoid Arthritis

Keywords

Rheumatoid Arthritisweb based interactive learning tool

Outcome Measures

Primary Outcomes (1)

  • The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks

    We classified subjects as having made an informed choice to escalate care if they answered at least 75% of the knowledge questions correctly and had low decisional conflict as defined by a score of 25 or lower on the combined subjective knowledge and values clarity subscales.

    2 weeks

Secondary Outcomes (9)

  • Patient-physician Communication

    8 weeks

  • Use of Biologics

    8 weeks

  • To Test Screening and Recruitment Procedures

    8 weeks

  • To Test Uptake

    8 weeks

  • Acceptability to Physicians

    8 weeks

  • +4 more secondary outcomes

Study Arms (2)

Decision Support Tool

OTHER

This study will examine the efficacy of a web-based educational decision support tool.

Other: Decision Support Tool

Usual Care

OTHER

Usual Care Group will receive their biologic drug teaching from their rheumatologist.

Other: Usual Care

Interventions

Decision Support ToolOTHER

Educational decision support tool for patients with rheumatoid arthritis

Decision Support Tool
Usual CareOTHER

Subjects randomized to the Usual Care Group will receive their biologic drug teaching from the rheumatologist as part of their routine care.

Usual Care

Eligibility Criteria

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

You may qualify if:

  • Subjects must be at least 18 years of age
  • Able to speak and read English
  • Meet the revised American College of Rheumatology criteria for the diagnosis of RA
  • Have active disease warranting initiation of a new biologic (or small molecule if and when FDA-approved) therapy as determined by their rheumatologist

You may not qualify if:

  • Have a current infection
  • Have cancer of any type diagnosed within the past five years (except non-melanoma skin cancer)
  • Have a history of lymphoma, leukemia, or melanoma
  • Have a chronic inflammatory disease (in addition to rheumatoid arthritis) requiring treatment with immunosuppressive medications
  • Have chronic liver disease due to hepatitis C or B
  • Are HIV positive
  • Have a positive screening test for tuberculosis (tuberculin skin test or interferon-gamma release assay) or radiographic lesions suggestive of inactive tuberculosis and have not completed an adequate course of chemoprophylactic therapy
  • Are hearing or visually impaired
  • Are scheduled for surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Geisinger Medical Center

Danville, Pennsylvania, 17822, United States

Location

Related Publications (1)

  • Fraenkel L, Matzko CK, Webb DE, Oppermann B, Charpentier P, Peters E, Reyna V, Newman ED. Use of Decision Support for Improved Knowledge, Values Clarification, and Informed Choice in Patients With Rheumatoid Arthritis. Arthritis Care Res (Hoboken). 2015 Nov;67(11):1496-502. doi: 10.1002/acr.22659.

    PMID: 26195173BACKGROUND

Related Links

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

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

Results Point of Contact

Title
Liana Fraenkel, MD, MPH, Department of Medicine
Organization
Yale University
liana.fraenkel@yale.edu

Study Officials

  • Liana Fraenkel, MD, MPH

    Yale University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2012

First Posted

November 5, 2012

Study Start

November 1, 2012

Primary Completion

February 1, 2015

Study Completion

February 1, 2015

Last Updated

February 19, 2018

Results First Posted

February 19, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

US(1)