CONfident Treatment Decisions in Living With Rheumatoid Arthritis (CONTROL-RA)
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Patient Educational Intervention
Patient Control
Sponsored by
About this trial
This is an interventional health services research trial for Rheumatoid Arthritis
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
Sites / Locations
- University of Alabama at Birmingham
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Patient Variation 1
Patient Variation 2
Arm Description
Patient Educational Intervention: Patient will receive intervention videos and will be required to complete the baseline and follow-up surveys.
Patient Control: Patients will receive an attention control and will be required to complete the baseline and follow-up surveys.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03317756
First Posted
September 12, 2017
Last Updated
August 29, 2021
Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer Independent Grants for Learning and Change
1. Study Identification
Unique Protocol Identification Number
NCT03317756
Brief Title
CONfident Treatment Decisions in Living With Rheumatoid Arthritis
Acronym
CONTROL-RA
Official Title
CONfident Treatment Decisions in Living With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
March 7, 2018 (Actual)
Primary Completion Date
September 1, 2020 (Actual)
Study Completion Date
September 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Pfizer Independent Grants for Learning and Change
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
intervention and control arms
Allocation
Randomized
Enrollment
208 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient Variation 1
Arm Type
Experimental
Arm Description
Patient Educational Intervention: Patient will receive intervention videos and will be required to complete the baseline and follow-up surveys.
Arm Title
Patient Variation 2
Arm Type
Experimental
Arm Description
Patient Control: Patients will receive an attention control and will be required to complete the baseline and follow-up surveys.
Intervention Type
Other
Intervention Name(s)
Patient Educational Intervention
Intervention Description
Patients will view 5-6 videos that will help them with pre-identified patient barriers to achieving RA low disease activity
Intervention Type
Other
Intervention Name(s)
Patient Control
Intervention Description
Patients will receive an attention control
Primary Outcome Measure Information:
Title
Patient willingness to adopt T2T and the attainment of the T2T goals.
Description
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.
Time Frame
Follow-up Survey #1 (after completion of the intervention)
Other Pre-specified Outcome Measures:
Title
Acceptability of the educational interventions
Description
We will ask participants to rate the educational content.
Time Frame
Follow up Survey #1 (after completion of intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria I Danila, MD MSc MSPH
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No individual data. Aggregate results will be reported.
Learn more about this trial
CONfident Treatment Decisions in Living With Rheumatoid Arthritis
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