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"Learning About Biologics"-Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT01721200
Recruitment Status : Completed
First Posted : November 5, 2012
Results First Posted : February 19, 2018
Last Update Posted : February 19, 2018
Sponsor:
Collaborator:
Yale University
Information provided by (Responsible Party):
Geisinger Clinic

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Supportive Care
Condition: Rheumatoid Arthritis
Interventions: Other: Decision Support Tool
Other: Usual Care

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were RA patients currently being treated by one of six rheumatologists practicing in the Geisinger Rheumatology Department in Danville, Pennsylvania who were at least 18 years of age, able to speak and read English & had active disease warranting initiation, or change, of a biologic therapy as determined by their treating rheumatologist.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects excluded if hearing or visually impaired; scheduled for surgery;current infection; cancer past five years (except non-melanoma),lymphoma, leukemia,melanoma;chronic inflammatory disease (+ RA) immunosuppressive RX; chronic liver disease, hepatitis C or B;HIV +; TB+x-ray lesions of inactive TB & no chemoprophylactic therapy..

Reporting Groups
  Description
Decision Support Tool

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

Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis

Usual Care

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

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


Participant Flow:   Overall Study
    Decision Support Tool   Usual Care
STARTED   62   63 
Completed 2 Week Follow-up   60   61 
COMPLETED   59   58 
NOT COMPLETED   3   5 
Lost to Follow-up                3                5 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

152 subjects approached. out of this number 125 patients agreed to participate and were randomized.

125 subjects completed baseline survey. 63 were randomized to control group and 62 to intervention. 61 completed two week follow-up survey in control group and 60 in intervention group.

58 completed 8 week survey and 59 in intervention group.


Reporting Groups
  Description
Decision Support Tool

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

Decision Support Tool: Educational decision support tool for patients with rheumatoid arthritis

Usual Care

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

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

Total Total of all reporting groups

Baseline Measures
   Decision Support Tool   Usual Care   Total 
Overall Participants Analyzed 
[Units: Participants]
 62   63   125 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      62 100.0%      63 100.0%      125 100.0% 
>=65 years      0   0.0%      0   0.0%      0   0.0% 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.3  (13.3)   56.2  (11.4)   55.3  (12.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      41  66.1%      44  69.8%      85  68.0% 
Male      21  33.9%      19  30.2%      40  32.0% 
Race/Ethnicity, Customized 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   0   0   0 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   0   1   1 
White   59   59   118 
More than one of the above races   0   0   0 
Unknown or Not Reported   3   3   6 


  Outcome Measures

1.  Primary:   The Proportion of Subjects Who Are Classified as Having Made an Informed Value Concordant Choice at 2 Weeks   [ Time Frame: 2 weeks ]

2.  Secondary:   Patient-physician Communication   [ Time Frame: 8 weeks ]

3.  Secondary:   Use of Biologics   [ Time Frame: 8 weeks ]

4.  Secondary:   To Test Screening and Recruitment Procedures   [ Time Frame: 8 weeks ]

5.  Secondary:   To Test Uptake   [ Time Frame: 8 weeks ]

6.  Secondary:   Acceptability to Physicians   [ Time Frame: 8 weeks ]

7.  Secondary:   To Test Adherence to the Intervention   [ Time Frame: 8 weeks ]

8.  Secondary:   Changes in Knowledge   [ Time Frame: 8 weeks ]

9.  Secondary:   Changes in Willingness   [ Time Frame: 8 weeks ]

10.  Secondary:   Changes in Perceived Knowledge   [ Time Frame: 8 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Liana Fraenkel, MD, MPH, Department of Medicine
Organization: Yale University
e-mail: liana.fraenkel@yale.edu


Publications:

Responsible Party: Geisinger Clinic
ClinicalTrials.gov Identifier: NCT01721200     History of Changes
Other Study ID Numbers: 2012-0294
12-003011 ( Other Identifier: Yale University )
First Submitted: October 10, 2012
First Posted: November 5, 2012
Results First Submitted: February 15, 2016
Results First Posted: February 19, 2018
Last Update Posted: February 19, 2018