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Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05423678
Collaborator
(none)
500
Enrollment
24
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Clinical trial participation has always been substantially skewed toward certain demographic groups. However, there has been little study on whether trial qualities impact participation in either a positive or negative way. The goal of this research is to identify the characteristics that consistently restrict patients' ability to participate in or complete a trial in which they were initially interested. This data will be analyzed via a number of demographic lenses in order to find trends that could benefit future ALS sufferers.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    In Depth Observational Clinical Trial - Analyzing Participation Experiences Of Amyotrophic Lateral Sclerosis Patients
    Anticipated Study Start Date :
    Jul 14, 2022
    Anticipated Primary Completion Date :
    Jul 14, 2023
    Anticipated Study Completion Date :
    Jul 14, 2024

    Outcome Measures

    Primary Outcome Measures

    1. Number of patient decides to enroll in clinical trial [3 months]

    2. Rate of patients who remain in clinical trial to trial completion [12 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Lives in the United States

    • Is 18+ years old

    • Participant has a diagnosis of Amyotrophic Lateral Sclerosis (ALS)

    • Participant has enrolled in an interventional clinical for ALS (self-reported)

    Exclusion Criteria

    • Inability to perform regular electronic reporting

    • Patient does not understand, sign, and return consent form

    • No diagnosis of Amyotrophic Lateral Sclerosis (ALS) confirmed

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Power Life Sciences Inc.

    Investigators

    • Study Director: Michael B Gill, Power Life Sciences Inc.

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Power Life Sciences Inc.
    ClinicalTrials.gov Identifier:
    NCT05423678
    Other Study ID Numbers:
    • 12207799
    First Posted:
    Jun 21, 2022
    Last Update Posted:
    Jun 21, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Power Life Sciences Inc.
    als
    als clinical trials
    als diversity studies
    amyotrophic lateral sclerosis
    Additional relevant MeSH terms:
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis
    Sclerosis

    Study Results

    No Results Posted as of Jun 21, 2022