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

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ClinicalTrials.gov Identifier: NCT03317756
Recruitment Status : Completed
First Posted : October 23, 2017
Last Update Posted : September 2, 2021
Sponsor:
Collaborator:
Pfizer Independent Grants for Learning and Change
Information provided by (Responsible Party):
Maria Danila, MD, MSc, MSPH, University of Alabama at Birmingham

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Other: Patient Educational Intervention Other: Patient Control Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: intervention and control arms
Primary Purpose: Health Services Research
Official Title: CONfident Treatment Decisions in Living With Rheumatoid Arthritis
Actual Study Start Date : March 7, 2018
Actual Primary Completion Date : September 1, 2020
Actual Study Completion Date : September 1, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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.



Other Outcome Measures:
  1. Acceptability of the educational interventions [ Time Frame: Follow up Survey #1 (after completion of intervention) ]
    We will ask participants to rate the educational content.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03317756


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Pfizer Independent Grants for Learning and Change
Investigators
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Principal Investigator: Maria I Danila, MD MSc MSPH University of Alabama at Birmingham
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Responsible Party: Maria Danila, MD, MSc, MSPH, Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT03317756    
Other Study ID Numbers: X151222003
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: September 2, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No individual data. Aggregate results will be reported.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases