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Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03495791
Recruitment Status : Unknown
Verified March 2019 by Rush University Medical Center.
Recruitment status was:  Recruiting
First Posted : April 12, 2018
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rush University Medical Center

Study Description
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Brief Summary:
This study will provide an educational intervention through means of a video to educate subjects on the risk of cardiovascular health on Rheumatoid arthritis.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Arthritis, Rheumatoid Other: YouTube Video Not Applicable

Detailed Description:
Subjects will be randomized into an interventional group and non-interventional group. Both groups will perform several surveys before an educational intervention may be given. Both Groups will come back 3 months post visit to complete additional surveys.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Web (YouTube) Based Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
Actual Study Start Date : October 31, 2016
Estimated Primary Completion Date : October 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: EI development phase. Other: YouTube Video
Educational Video
No Intervention: Pilot-testing phase.


Outcome Measures
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Primary Outcome Measures :
  1. Heart Disease Knowledge Questionnaire [ Time Frame: 3 Months ]
    30 items survey completed at baseline (pre-intervention, post intervention), and 3 month follow-up. Change in cardiovascular knowledge at 3 months and baseline (post-intervention) will be measured against baseline pre-intervention values.

  2. Heart Disease Fact Questionnaire [ Time Frame: 3 Months ]
    13 items survey completed at baseline (pre-intervention, post intervention), and 3 month follow-up. Change in cardiovascular awareness at 3 months and baseline (post-intervention) will be measured against baseline pre-intervention values.


Secondary Outcome Measures :
  1. Statues of Hyperlipidemia treatment [ Time Frame: 1 Year ]
    Change in hyperlipidemia treatment from Screening to 1 year.

  2. Cholesterol [ Time Frame: 1 year ]
    Change in Cholesterol from Screening to 1 year.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical Diagnoses of Rheumatoid Arthritis of at least 3 months by a Rheumatologist

Exclusion Criteria:

  • Inability to communicate in English.
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03495791


Contacts
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Contact: Rush University 312-942-2167

Locations
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United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612-3833
Contact: Meenakshi Jolly    312-942-2167      
Sponsors and Collaborators
Rush University Medical Center
Pfizer
  Study Documents (Full-Text)

Documents provided by Rush University Medical Center:
Study Protocol  [PDF] July 6, 2017

More Information
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Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03495791    
Other Study ID Numbers: 14090405
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Rush University Medical Center:
RA
Rheumatoid Arthritis
Arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases