CONfident Treatment Decisions in Living With Rheumatoid Arthritis

Study Purpose

Pilot test the novel educational patient-directed intervention to demonstrate the feasibility of the novel educational approaches developed in improving patient's willingness to achieve remission or low disease activity in RA.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Have a patient-reported diagnosis of RA.
  • - Most recent RAPID3 > 12 collected in the last 6 months.
  • - Have not changed RA medication in the last 6 months.
  • - Taking medications that are commonly used in RA (e.g. methotrexate, sulfasalazine, hydroxychloroquine (plaquenil), leflunomide (arava), etanercept (enbrel), adalimumab (Humira), tofacitinib (xeljanz), actemra (tocilizumab), sarilumab (Kevzara) , infliximab (remicade), golimumab (Simponi), rituximab (rituxan), abatacept (Orencia), and certolizumab (Cimzia))

    Exclusion Criteria:

    - Does not meet inclusion criteria.
- Age < 18

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03317756
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

University of Alabama at Birmingham
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Maria I Danila, MD MSc MSPH
Principal Investigator Affiliation University of Alabama at Birmingham
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Arthritis
Additional Details

Pilot test the novel educational patient-directed intervention to demonstrate the feasibility of the novel educational approaches developed in improving patient's willingness to achieve remission or low disease activity in RA. Upon agreement to participate, the patient participants will provide information on their treating physician. This information will be used to invite physicians to complete the physician-educational intervention and offered CME credits for completing the activity. The investigators will recruit participants from a patient registry (1:1 intervention: control) that meet the eligibility criteria. The recruited patients will complete the educational intervention (if randomized to the intervention arm) and the study outcomes will be collected immediately after the intervention and also after the patients most proximate rheumatologist visit (up to 6-months later).

Arms & Interventions

Arms

Experimental: Patient Variation 1

Patient Educational Intervention: Patient will receive intervention videos and will be required to complete the baseline and follow-up surveys.

Experimental: Patient Variation 2

Patient Control: Patients will receive an attention control and will be required to complete the baseline and follow-up surveys.

Interventions

Other: - Patient Educational Intervention

Patients will view 5-6 videos that will help them with pre-identified patient barriers to achieving RA low disease activity

Other: - Patient Control

Patients will receive an attention control

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of Alabama at Birmingham, Birmingham, Alabama

Status

Address

University of Alabama at Birmingham

Birmingham, Alabama, 35294