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CONfident Treatment Decisions in Living With Rheumatoid Arthritis

CONfident Treatment Decisions in Living With Rheumatoid Arthritis

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03317756
Acronym
CONTROL-RA
Enrollment
208
Registered
2017-10-23
Start date
2018-03-07
Completion date
2020-09-01
Last updated
2021-09-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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).

Interventions

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

OTHERPatient Control

Patients will receive an attention control

Sponsors

Pfizer Independent Grants for Learning and Change
CollaboratorUNKNOWN
University of Alabama at Birmingham
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Masking description

intervention and control arms

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Patient willingness to adopt T2T and the attainment of the T2T goals.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

MeasureTime frameDescription
Acceptability of the educational interventionsFollow up Survey #1 (after completion of intervention)We will ask participants to rate the educational content.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026