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OpenTrials
Completed

NCT Number: NCT03317756

CONfident Treatment Decisions in Living With Rheumatoid Arthritis

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patient Educational Intervention

Other

Patients will view 5-6 videos that will help them with pre-identified patient barriers to achieving RA low disease activity

Patient Control

Other

Patients will receive an attention control

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Pfizer Independent Grants for Learning and Change

Registry information

Acronym: CONTROL-RA

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 23, 2017
Registry last updated
Sep 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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