NCT03495791

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable rheumatoid-arthritis

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable rheumatoid-arthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 31, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 14, 2018

Completed
29 days until next milestone

First Posted

Study publicly available on registry

April 12, 2018

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

May 3, 2022

Status Verified

May 1, 2022

Enrollment Period

5.2 years

First QC Date

March 14, 2018

Last Update Submit

May 2, 2022

Conditions

Rheumatoid ArthritisArthritis, Rheumatoid

Keywords

RARheumatoid ArthritisArthritis

Outcome Measures

Primary Outcomes (2)

  • 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.

    3 Months

  • 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.

    3 Months

Secondary Outcomes (2)

  • Statues of Hyperlipidemia treatment

    1 Year

  • Cholesterol

    1 year

Study Arms (2)

EI development phase.

EXPERIMENTAL
Other: YouTube Video

Pilot-testing phase.

NO INTERVENTION

Interventions

YouTube VideoOTHER

Educational Video

EI development phase.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Inability to communicate in English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rush University Medical Center

Chicago, Illinois, 60612-3833, United States

Location

MeSH Terms

Conditions

Arthritis, RheumatoidArthritis

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2018

First Posted

April 12, 2018

Study Start

October 31, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

May 3, 2022

Record last verified: 2022-05

Locations

US(1)