CONfident Treatment Decisions in Living With Rheumatoid Arthritis (CONTROL-RA)

The University of Alabama at Birmingham

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Other: Patient Control; Other: Patient Educational Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03317756

X151222003

Details and patient eligibility

About

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.

Full 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).

Enrollment: 208 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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208 participants in 2 patient groups

Patient Variation 1

Experimental group

Description:

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

Treatment:

Other: Patient Educational Intervention

Patient Variation 2

Experimental group

Description:

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

Treatment:

Other: Patient Control