CONfident Treatment Decisions in Living With Rheumatoid Arthritis

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Other: Patient Control; Other: Patient Educational Intervention

• Registration Number: NCT03317756
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2017-09-12
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-23
• Study Start: 2018-03-07
• Primary Completion: 2020-09-01
• Study Completion: 2020-09-01
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-29
• Last Update Posted: 2021-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 208

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))

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Exclusion Criteria

• Does not meet inclusion criteria
• Age < 18

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patient Variation 2	Patient Control	Patient Control: Patients will receive an attention control and will be required to complete the baseline and follow-up surveys.
Patient Variation 1	Patient Educational Intervention	Patient Educational Intervention: Patient will receive intervention videos and will be required to complete the baseline and follow-up surveys.

Primary Outcome Measures

Name	Time	Method
Patient willingness to adopt T2T and the attainment of the T2T goals.	Follow-up Survey #1 (after completion of the intervention)	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.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States