Medical Trial: Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients

NCT05398471 | Not Yet Recruiting

• 1 other identifier: 58103638
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (2)

• Patient decides to enroll in clinical trial

  3 Months

• Patient remains in clinical trial to completion

  12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• ECOG score of 4
• Patient is pregnant
• Inability to perform regular electronic reporting
• Patient does not understand, sign, and return consent form

Sponsors & Collaborators

• Power Life Sciences Inc.: lead

Study Sites (1)

Power Life Sciences

San Francisco, California, 94107, United States

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Michael B Gill

  Power Life Sciences Inc.

  STUDY DIRECTOR

Central Study Contacts

Michael B Gill

CONTACT

(415) 287-9919; bask@withpower.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2022
• First Posted: June 1, 2022
• Study Start: August 1, 2024
• Primary Completion: August 1, 2025
• Study Completion: August 1, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12

Locations

US (1)