- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03495791
Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
May 2, 2022 updated by: Rush University Medical Center
Web (YouTube) Based Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
This study will provide an educational intervention through means of a video to educate subjects on the risk of cardiovascular health on Rheumatoid arthritis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
300
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612-3833
- Rush University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Clinical Diagnoses of Rheumatoid Arthritis of at least 3 months by a Rheumatologist
Exclusion Criteria:
- Inability to communicate in English.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EI development phase.
|
Educational Video
|
No Intervention: Pilot-testing phase.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 Months
|
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.
|
3 Months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Statues of Hyperlipidemia treatment
Time Frame: 1 Year
|
Change in hyperlipidemia treatment from Screening to 1 year.
|
1 Year
|
Cholesterol
Time Frame: 1 year
|
Change in Cholesterol from Screening to 1 year.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 31, 2016
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
March 14, 2018
First Submitted That Met QC Criteria
April 10, 2018
First Posted (Actual)
April 12, 2018
Study Record Updates
Last Update Posted (Actual)
May 3, 2022
Last Update Submitted That Met QC Criteria
May 2, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14090405
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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