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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Other: Patient Educational Intervention; Other: Patient Control

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 Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Patient Variation 1; Patient Educational Intervention: Patient will receive intervention videos and will be required to complete the baseline and follow-up surveys.	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
Experimental: Patient Variation 2; Patient Control: Patients will receive an attention control and will be required to complete the baseline and follow-up surveys.	Other: Patient Control; Patients will receive an attention control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of the educational interventions	We will ask participants to rate the educational content.	Follow up Survey #1 (after completion of intervention)

Collaborators and Investigators

• Sponsor: University of Alabama at Birmingham
• Collaborators: Pfizer Independent Grants for Learning and Change
• Investigators: Principal Investigator: Maria I Danila, MD MSc MSPH, University of Alabama at Birmingham

Study record dates

Study Major Dates

• Study Start (Actual): March 7, 2018
• Primary Completion (Actual): September 1, 2020
• Study Completion (Actual): September 1, 2020

Study Registration Dates

• First Submitted: September 12, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 23, 2017

Study Record Updates

• Last Update Posted (Actual): September 2, 2021
• Last Update Submitted That Met QC Criteria: August 29, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: X151222003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual data. Aggregate results will be reported.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No