Discovering Clinical Study Experiences of Patients With Pulmonary Hypertension

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05918458
Collaborator
(none)
500
1
24
20.8

Study Details

Study Description

Brief Summary

Taking part in medical trials usually favors a particular demographic group. But there is limited research available to explain what trial attributes affect the completion of these specific demographic groups.

This study will admit a wide range of data on the clinical trial experience of pulmonary hypertension patients to determine which factors prevail in limiting a patient's ability to join or finish a trial.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future pulmonary hypertension patients.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Pulmonary Hypertension Clinical Trials: What Are Prevailing Patient Experiences in Pulmonary Hypertension Studies
    Anticipated Study Start Date :
    Jul 1, 2024
    Anticipated Primary Completion Date :
    Jul 1, 2025
    Anticipated Study Completion Date :
    Jul 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who decide to enroll in a pulmonary hypertension clinical research [3 months]

    2. Rate of patients who remain in pulmonary hypertension clinical research 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:
    • Aged ≥ 18 years old

    • Able to comprehend the investigational nature of the protocol and provide informed consent

    • Diagnosis of pulmonary hypertension

    Exclusion Criteria:
    • No diagnosis of pulmonary hypertension confirmed

    • Inability to perform regular electronic reporting

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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Power Life Sciences San Francisco California United States 94107

    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:
    NCT05918458
    Other Study ID Numbers:
    • 82814554
    First Posted:
    Jun 26, 2023
    Last Update Posted:
    Jun 26, 2023
    Last Verified:
    Jun 1, 2023
    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.
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 26, 2023