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
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Tracking Information | |||||
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First Submitted Date ICMJE | September 12, 2017 | ||||
First Posted Date ICMJE | October 23, 2017 | ||||
Last Update Posted Date | September 2, 2021 | ||||
Actual Study Start Date ICMJE | March 7, 2018 | ||||
Actual Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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.
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Original Primary Outcome Measures ICMJE |
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.
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Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE |
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Current Other Pre-specified Outcome Measures |
Acceptability of the educational interventions [ Time Frame: Follow up Survey #1 (after completion of intervention) ] We will ask participants to rate the educational content.
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Original Other Pre-specified Outcome Measures |
Acceptability of the educational interventions [ Time Frame: Follow up Survey #1 (Month 0) ] We will ask participants to rate the educational content.
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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). |
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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
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Condition ICMJE | Rheumatoid Arthritis | ||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Actual Enrollment ICMJE |
208 | ||||
Original Estimated Enrollment ICMJE |
532 | ||||
Actual Study Completion Date ICMJE | September 1, 2020 | ||||
Actual Primary Completion Date | September 1, 2020 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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IPD Sharing Statement ICMJE |
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Responsible Party | Maria Danila, MD, MSc, MSPH, University of Alabama at Birmingham | ||||
Study Sponsor ICMJE | University of Alabama at Birmingham | ||||
Collaborators ICMJE | Pfizer Independent Grants for Learning and Change | ||||
Investigators ICMJE |
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PRS Account | University of Alabama at Birmingham | ||||
Verification Date | August 2021 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |