CONfident Treatment Decisions in Living With Rheumatoid Arthritis

NCT ID: NCT03317756

Last Updated: 2021-09-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 208 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-07
• Study Completion Date: 2020-09-01

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).

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Patient Variation 1

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

Group Type: EXPERIMENTAL

Patient Educational Intervention

Intervention Type: OTHER

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

Patient Variation 2

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

Group Type: EXPERIMENTAL

Patient Control

Intervention Type: OTHER

Patients will receive an attention control

Interventions

Patient Educational Intervention

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

Intervention Type: OTHER

Patient Control

Patients will receive an attention control

Intervention Type: OTHER

Eligibility 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))

• Age < 18

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pfizer Independent Grants for Learning and Change

UNKNOWN

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Maria Danila, MD, MSc, MSPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria I Danila, MD MSc MSPH

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

X151222003

Identifier Type: -

Identifier Source: org_study_id