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
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Other: Patient Educational Intervention Other: Patient Control||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||208 participants|
|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|
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
- 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.
- Acceptability of the educational interventions [ Time Frame: Follow up Survey #1 (after completion of intervention) ]We will ask participants to rate the educational content.
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
|United States, Alabama|
|University of Alabama at Birmingham|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Maria I Danila, MD MSc MSPH||University of Alabama at Birmingham|