- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05398471
Medical Trial: Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients
December 29, 2023 updated by: Power Life Sciences Inc.
Observational Clinical Trial Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients Participating In Clinical Research
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.
Study Overview
Status
Not yet recruiting
Conditions
Study Type
Observational
Enrollment (Estimated)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Michael B Gill
- Phone Number: (415) 287-9919
- Email: bask@withpower.com
Study Locations
-
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California
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San Francisco, California, United States, 94107
- Power Life Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Rheumatoid arthritis patients who are actively considering enrolling in an interventional clinical trial, but have not yet completed enrollment and randomization.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Patient decides to enroll in clinical trial
Time Frame: 3 Months
|
3 Months
|
Patient remains in clinical trial to completion
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Michael B Gill, Power Life Sciences Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
August 1, 2024
Primary Completion (Estimated)
August 1, 2025
Study Completion (Estimated)
August 1, 2026
Study Registration Dates
First Submitted
May 26, 2022
First Submitted That Met QC Criteria
May 26, 2022
First Posted (Actual)
June 1, 2022
Study Record Updates
Last Update Posted (Estimated)
January 1, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 58103638
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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