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

• ClinicalTrials.gov Identifier: NCT03317756
• Recruitment Status: Enrolling by invitation
• First Posted: October 23, 2017
• Last Update Posted: November 12, 2019
• Sponsor: University of Alabama at Birmingham
• Collaborator: Pfizer Independent Grants for Learning and Change
• Information provided by (Responsible Party): Maria Danila, University of Alabama at Birmingham

Tracking Information

• First Submitted Date: September 12, 2017
• First Posted Date: October 23, 2017
• Last Update Posted Date: November 12, 2019
• Actual Study Start Date: March 7, 2018
• Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 9, 2018)

Patient willingness to adopt T2T and the attainment of the T2T goals. [ Time Frame: 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.

Original Primary Outcome Measures (submitted: October 17, 2017)

Patient willingness to adopt T2T and the attainment of the T2T goals. [ Time Frame: Follow up Survey #1 (Month 0) ]

Will be measured using the validated choice predisposition scale that reflects preference for a specific treatment.

• Current Secondary Outcome Measures: Not Provided

Original Secondary Outcome Measures (submitted: October 17, 2017)

• Changes in the patient's decisional conflict regarding treatment [ Time Frame: Follow up Survey #1 (Month 0) ]
  Will be assessed using the validated 16-item Decisional Conflict Scale (DCS)
• Changes in the patient's decisional conflict regarding treatment [ Time Frame: Follow-up survey #2 (after doctor visit, within 6 months of the intervention) ]
  Will be assessed using the validated 16-item Decisional Conflict Scale (DCS)
• Educational effectiveness [ Time Frame: Follow up Survey #1 (Month 0) ]
  We will develop knowledge assessment questions to measure patient knowledge of RA treatment.
• Patient willingness to adopt T2T and the attainment of the T2T goals. [ Time Frame: Follow-up survey #2 (after doctor visit, within 6 months of the intervention) ]
  Will be measured using the validated choice predisposition scale that reflects preference for a specific treatment.

Current Other Pre-specified Outcome Measures (submitted: January 9, 2018)

Acceptability of the educational interventions [ Time Frame: Follow up Survey #1 (after completion of intervention) ]

We will ask participants to rate the educational content.

Original Other Pre-specified Outcome Measures (submitted: October 17, 2017)

Acceptability of the educational interventions [ Time Frame: Follow up Survey #1 (Month 0) ]

We will ask participants to rate the educational content.

Descriptive Information

• Brief Title: CONfident Treatment Decisions in Living With Rheumatoid Arthritis
• Official Title: CONfident Treatment Decisions in Living With Rheumatoid Arthritis
• 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 Type: Interventional
• Study Phase: Not Applicable

Study Design

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:

intervention and control arms

Primary Purpose: Health Services Research

• Condition: Rheumatoid Arthritis

Intervention

• 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
• Other: Patient Control
  Patients will receive an attention control

Study Arms

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: October 17, 2017): 532
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: September 1, 2020
• Estimated Primary Completion Date: September 1, 2020 (Final data collection date for primary outcome measure)

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))

Exclusion Criteria:

• Does not meet inclusion criteria
• Age < 18

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03317756
• Other Study ID Numbers: X151222003
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No
• Plan Description: No individual data. Aggregate results will be reported.

• Responsible Party: Maria Danila, University of Alabama at Birmingham
• Study 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

• PRS Account: University of Alabama at Birmingham
• Verification Date: November 2019