Revealing Engagement Dynamics Among Diabetic Kidney Disease Patients

Sponsor
Power Life Sciences Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT06101901
Collaborator
(none)
500
1
24
20.8

Study Details

Study Description

Brief Summary

The study intends to investigate the personal experiences of diabetic kidney disease patients who take part in a separate clinical study including a specific medication intervention. The major focus will be on closely following individuals' rates of trial completion and withdrawal.

The data collected from this study will help improve future outcomes for all diabetic kidney disease as well as those in under-represented demographic groups.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    500 participants
    Observational Model:
    Case-Crossover
    Time Perspective:
    Prospective
    Official Title:
    Studying Patterns in Patient Engagement and Participation in Diabetic Kidney Disease Clinical Trials
    Anticipated Study Start Date :
    Nov 1, 2024
    Anticipated Primary Completion Date :
    Nov 1, 2025
    Anticipated Study Completion Date :
    Nov 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Number of patients who decide to enroll in a diabetic kidney disease clinical research [3 months]

    2. Rate of patients who remain in a diabetic kidney disease 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:
    • Patients diagnosed with diabetic kidney disease

    • Aged ≥ 18 years old and ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed

    • Subjects willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examination.

    Exclusion Criteria:
    • Refusal of consent

    • Women of childbearing potential without a negative pregnancy test; or women who are lactating.

    • Any serious and/or unstable pre-existing medical disorders

    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:
    NCT06101901
    Other Study ID Numbers:
    • 63894857
    First Posted:
    Oct 26, 2023
    Last Update Posted:
    Oct 26, 2023
    Last Verified:
    Oct 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 Oct 26, 2023