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Trial record 1 of 1 for:    NCT03495791
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Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.

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ClinicalTrials.gov Identifier: NCT03495791
Recruitment Status : Recruiting
First Posted : April 12, 2018
Last Update Posted : March 28, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Rush University Medical Center

Tracking Information
First Submitted Date  ICMJE March 14, 2018
First Posted Date  ICMJE April 12, 2018
Last Update Posted Date March 28, 2019
Actual Study Start Date  ICMJE October 31, 2016
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • Statues of Hyperlipidemia treatment [ Time Frame: 1 Year ]
    Change in hyperlipidemia treatment from Screening to 1 year.
  • Cholesterol [ Time Frame: 1 year ]
    Change in Cholesterol from Screening to 1 year.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
Official Title  ICMJE Web (YouTube) Based Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Condition  ICMJE
  • Rheumatoid Arthritis
  • Arthritis, Rheumatoid
Intervention  ICMJE Other: YouTube Video
Educational Video
Study Arms  ICMJE
  • Experimental: EI development phase.
    Intervention: Other: YouTube Video
  • No Intervention: Pilot-testing phase.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2020
Estimated Primary Completion Date October 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to communicate in English.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Rush University 312-942-2167
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03495791
Other Study ID Numbers  ICMJE 14090405
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Rush University Medical Center
Study Sponsor  ICMJE Rush University Medical Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Rush University Medical Center
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP