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

Primary Purpose

Rheumatoid Arthritis, Arthritis, Rheumatoid

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
YouTube Video
Sponsored by
Rush University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Rheumatoid Arthritis focused on measuring RA, Rheumatoid Arthritis, Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Inability to communicate in English.

Sites / Locations

  • Rush University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

EI development phase.

Pilot-testing phase.

Arm Description

Outcomes

Primary Outcome Measures

Heart Disease Knowledge Questionnaire
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
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

Statues of Hyperlipidemia treatment
Change in hyperlipidemia treatment from Screening to 1 year.
Cholesterol
Change in Cholesterol from Screening to 1 year.

Full Information

First Posted
March 14, 2018
Last Updated
May 2, 2022
Sponsor
Rush University Medical Center
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03495791
Brief Title
Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
Official Title
Web (YouTube) Based Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
October 31, 2016 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rush University Medical Center
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis, Arthritis, Rheumatoid
Keywords
RA, Rheumatoid Arthritis, Arthritis

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EI development phase.
Arm Type
Experimental
Arm Title
Pilot-testing phase.
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
YouTube Video
Intervention Description
Educational Video
Primary Outcome Measure Information:
Title
Heart Disease Knowledge Questionnaire
Description
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.
Time Frame
3 Months
Title
Heart Disease Fact Questionnaire
Description
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.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Statues of Hyperlipidemia treatment
Description
Change in hyperlipidemia treatment from Screening to 1 year.
Time Frame
1 Year
Title
Cholesterol
Description
Change in Cholesterol from Screening to 1 year.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical Diagnoses of Rheumatoid Arthritis of at least 3 months by a Rheumatologist Exclusion Criteria: Inability to communicate in English.
Facility Information:
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612-3833
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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