Medical Trial: Appraising Medical Trial Experiences of Rheumatoid Arthritis Patients

NCT ID: NCT05398471

Last Updated: 2024-01-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-31

Study Completion Date

2026-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Power Life Sciences Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Michael B Gill

Role: STUDY_DIRECTOR

Power Life Sciences Inc.

Locations

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Power Life Sciences

San Francisco, California, United States

Site Status

Countries

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United States

Central Contacts

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Michael B Gill

Role: CONTACT

(415) 287-9919

References

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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.

Reference Type BACKGROUND
PMID: 34800100 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32903246 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34108677 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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58103638

Identifier Type: -

Identifier Source: org_study_id

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