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Trial record 1 of 1 for:    NCT03317756
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CONfident Treatment Decisions in Living With Rheumatoid Arthritis (CONTROL-RA)

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ClinicalTrials.gov Identifier: NCT03317756
Recruitment Status : Enrolling by invitation
First Posted : October 23, 2017
Last Update Posted : November 12, 2019
Sponsor:
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  ICMJE September 12, 2017
First Posted Date  ICMJE October 23, 2017
Last Update Posted Date November 12, 2019
Actual Study Start Date  ICMJE March 7, 2018
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (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  ICMJE CONfident Treatment Decisions in Living With Rheumatoid Arthritis
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
intervention and control arms
Primary Purpose: Health Services Research
Condition  ICMJE Rheumatoid Arthritis
Intervention  ICMJE
  • 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  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: October 17, 2017)
532
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03317756
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE Pfizer Independent Grants for Learning and Change
Investigators  ICMJE
Principal Investigator: Maria I Danila, MD MSc MSPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP