Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Layout table for study information
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


Arm Intervention/treatment
Experimental: EI development phase. Other: YouTube Video
Educational Video

No Intervention: Pilot-testing phase.



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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.

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
Layout table for location contacts
Contact: Rush University 312-942-2167

Locations
Layout table for location information
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


Layout table for additonal information
Responsible Party: Rush University Medical Center
ClinicalTrials.gov Identifier: NCT03495791     History of Changes
Other Study ID Numbers: 14090405
First Posted: April 12, 2018    Key Record Dates
Last Update Posted: March 28, 2019
Last Verified: March 2019

Layout table for additional information
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:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases