CONfident Treatment Decisions in Living With Rheumatoid Arthritis

NCT03317756 | Completed

• 1 other identifier: X151222003
• Study Type: interventional
• Target: 208
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Acceptability of the educational interventions

  Follow up Survey #1 (after completion of intervention)

Study Arms (2)

Patient Variation 1

EXPERIMENTAL

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

Other: Patient Educational Intervention

Patient Variation 2

EXPERIMENTAL

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

Other: Patient Control

Interventions

Patient Educational Intervention OTHER

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

Patient Variation 1

Patient Control OTHER

Patients will receive an attention control

Patient Variation 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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))

You may not qualify if:

• Age \< 18

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Pfizer Independent Grants for Learning and Change: collaborator

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Maria I Danila, MD MSc MSPH

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: intervention and control arms
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: October 23, 2017
• Study Start: March 7, 2018
• Primary Completion: September 1, 2020
• Study Completion: September 1, 2020
• Last Updated: September 2, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)