CONfident Treatment Decisions in Living With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— CONTROL-RA  

Official title:

CONfident Treatment Decisions in Living With Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03317756
• Other study ID #: X151222003
• Status: Completed
• Phase: N/A
• Start date: March 7, 2018
• Est. completion date: September 1, 2020

Study information

• Verified date: August 2021
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 208
• Est. completion date: September 1, 2020
• Est. primary completion date: September 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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
• Patient Control
Patients will receive an attention control

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Pfizer Independent Grants for Learning and Change

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Acceptability of the educational interventions	We will ask participants to rate the educational content.	Follow up Survey #1 (after completion of intervention)
Primary	Patient willingness to adopt T2T and the attainment of the T2T goals.	Name of Scale: Choice predisposition scale The scale measures the willingness to change medication. The scale is a 11-point likert type scale that is scored from not willing at all (minimum) to extremely willing (maximum) with an unsure option (neutral).; Higher scores (closer to the maximum) indicate a willingness to change medication and desire to further improve their RA disease activity.	Follow-up Survey #1 (after completion of the intervention)