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

• Sponsor: Rush University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03495791
• Collaborator: Pfizer (Industry)
• Enrollment: 300
• Location: 1
• Arms: 2
• Actual Duration (Months): 62
• Patients Per Site Per Month: 4.8

Study Details

Study Description

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	N/A

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

• Study Type: Interventional
• Actual Enrollment: 300 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: Oct 31, 2016
• Actual Primary Completion Date: Dec 31, 2021
• Actual Study Completion Date: Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: EI development phase.	Other: YouTube Video; Educational Video
No Intervention: Pilot-testing phase.

Outcome Measures

Primary Outcome Measures

1. Heart Disease Knowledge Questionnaire [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 [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 [1 Year]

   Change in hyperlipidemia treatment from Screening to 1 year.

2. Cholesterol [1 year]

   Change in Cholesterol from Screening to 1 year.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Rush University Medical Center	Chicago	Illinois	United States	60612-3833

Sponsors and Collaborators

• Rush University Medical Center
• Pfizer

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol - Jul 6, 2017

More Information

Publications

None provided.

• Responsible Party: Rush University Medical Center
• ClinicalTrials.gov Identifier: NCT03495791
• Other Study ID Numbers: 14090405
• First Posted: Apr 12, 2018
• Last Update Posted: May 3, 2022
• Last Verified: May 1, 2022

• 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: Arthritis; Arthritis, Rheumatoid

Study Results

No Results Posted as of May 3, 2022