Rheumatoid ArthritisNCT03495791
Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
A study testing YouTube Video in people with Rheumatoid Arthritis and Arthritis, Rheumatoid, run by Rush University Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Arthritis, Rheumatoid
- What is being tested?
- YouTube Video
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2016to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical Diagnoses of Rheumatoid Arthritis of at least 3 months by a Rheumatologist
Who cannot join
- Inability to communicate in English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Rush University Medical Center
Chicago, Illinois, 60612-3833
About this study
Official title: 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.
Read the 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.
- Conditions
- Rheumatoid Arthritis, Arthritis, Rheumatoid
- Being tested
- YouTube Video
- Keywords
- RA, Rheumatoid Arthritis, Arthritis
- Medical subject headings
- Arthritis, Rheumatoid, Arthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YouTube VideoOther
Educational Video
| Study group | Role | What they receive |
|---|---|---|
| EI development phase. | Experimental | Not described Receives: Other: YouTube Video |
| Pilot-testing phase. | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 3 Months
Secondary outcomes (2)
Statues of Hyperlipidemia treatment
Change in hyperlipidemia treatment from Screening to 1 year.
Measured: 1 Year
Cholesterol
Change in Cholesterol from Screening to 1 year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study start31 Oct 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Rush University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rush University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03495791
- Sponsor's protocol ID
- 14090405
- Status last verified
- May 2022
- First submitted
- 14 Mar 2018
- Last updated
- 3 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web (YouTube) Based Educational Intervention to Improve Patient-Physician Awareness of Cardiovascular Risk in Rheumatoid Arthritis.
- ClinicalTrials.gov ID
- NCT03495791
- Acronym / sponsor ID
- 14090405
- Conditions
- Rheumatoid Arthritis, Arthritis, Rheumatoid
- Keywords
- RA, Rheumatoid Arthritis, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Rush University Medical CenterUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- 31 Oct 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EI development phase. | Experimental | Other: YouTube Video |
| Pilot-testing phase. | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Clinical Diagnoses of Rheumatoid Arthritis of at least 3 months by a Rheumatologist
Key exclusion criteria (1 listed)
- Inability to communicate in English.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| YouTube VideoEducational Video | Other | EI development phase. |
Primary outcome
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.
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.
2 secondary outcomes
Statues of Hyperlipidemia treatment
Time frame: 1 Year
Cholesterol
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing YouTube Video in people with Rheumatoid Arthritis and Arthritis, Rheumatoid, run by Rush University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart Disease Knowledge Questionnaire (time frame: 3 Months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2022.