Medical Trial: Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Rheumatoid Arthritis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Observational Clinical Trial Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients Participating In Clinical Research
Overview
Historically, participation in clinical trials has been highly skewed towards specific demographic groups. However, research identifying which trial attributes impact participation, in either positive or negative ways, is limited. This study invites participants to record a wide range of data on their clinical trial experience, with the goal being to identify factors which persistently limit patients' ability to participate in, or complete, a trial in which they were initially interested. This data will be analyzed through a range of demographic lenses, in hopes of discovering patterns which might improve the experience of future rheumatoid arthritis patients.
Primary outcome measures
- Patient decides to enroll in clinical trial [Time frame: 3 Months]
- Patient remains in clinical trial to completion [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- Patient has been diagnosed with rheumatoid arthritis
- Patient has self-identified as planning to enroll in an interventional clinical trial
- Patient is 18 years old
Exclusion criteria
- ECOG score of 4
- Patient is pregnant
- Inability to perform regular electronic reporting
- Patient does not understand, sign, and return consent form
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-crossover
Study locations
United States · 1 center
- Power Life Sciences — San Francisco
Publications
- McKinney M, Bell R, Samborski C, Attwood K, Dean G, Eakle K, Yu W, Edge S. Clinical Trial Participation: A Pilot Study of Patient-Identified Barriers. Clin J Oncol Nurs. 2021 Dec 1;25(6):647-654. doi: 10.1188/21.CJON.647-654. PMID 34800100
- Lansey DG, Hefka TA, Carducci MA, Kanarek NF. Problem Solving to Enhance Clinical Trial Participation Utilizing a Framework-Driven Approach. Clin Adv Hematol Oncol. 2020 Aug;18(8):468-476. PMID 32903246
- Michos ED, Van Spall HGC. Increasing representation and diversity in cardiovascular clinical trial populations. Nat Rev Cardiol. 2021 Aug;18(8):537-538. doi: 10.1038/s41569-021-00583-8. No abstract available. PMID 34108677
Identifiers
NCT: NCT05398471 · 58103638