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A Study to Evaluate Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures Among Healthcare Professionals in Canada

Sponsor
Allergan (Industry)
Overall Status
Withdrawn
CT.gov ID
NCT04567589
Collaborator
(none)
0
Enrollment
1
Location
5
Anticipated Duration (Months)
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a non-interventional, cross-sectional survey study to evaluate the effectiveness of the Additional Risk Minimization Measures for Fibristal among Healthcare Professionals (HCPs).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Data will be collected via web-based data capture by HCPs submitting surveys. The survey will be conducted in a single wave over 6 months. All data will be maintained in compliance with local regulations.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    0 participants
    Observational Model:
    Other
    Time Perspective:
    Other
    Official Title:
    A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures
    Actual Study Start Date :
    Sep 30, 2020
    Anticipated Primary Completion Date :
    Feb 28, 2021
    Anticipated Study Completion Date :
    Feb 28, 2021

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of HCPs with correct responses to the knowledge level questions. [18 - 24 months]

      Correct responses to knowledge-related questions based on the contents of the Fibristal aRMMs.

    Secondary Outcome Measures

    1. Percentage of HCPs that recall receiving and reading the HCP Letter and HCP Brochure . [18 - 24 months]

      HCP's recall of receiving and reading the HCP Letter and HCP Brochure .

    2. Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card [18 - 24 months]

      HCP's recall of distributing the Fibristal Patient Alert Card

    3. Percentage of patients who recall counselling patients on information included in the Patient Alert Card [18 - 24 months]

      HCP's recall of counselling patients on information included in the Patient Alert Card

    4. Overall score for each HCP will be calculated that totals the correct responses to all of the knowledge-related questions [18 - 24 months]

      Composite score on the level of HCPs knowledge across all knowledge-related questions.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • HCPs have prescribed Fibristal for the indication of uterine fibroids within the past 6 months.

    • HCPs have provided permission to share their responses in aggregate to Health Canada.

    Exclusion Criteria:

    • HCPs who participated in the cognitive pre-testing of the survey questionnaire to be used for the study.

    • HCPs who have been direct employees of Allergan, ICON, Health Canada, or Professional Targeted Marketing (PTM) within the past 5 years.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinical Trials Registry Team Irvine California United States 92622

    Sponsors and Collaborators

    • Allergan

    Investigators

    • Study Director: Ahunna Ukah, Allergan

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Allergan
    ClinicalTrials.gov Identifier:
    NCT04567589
    Other Study ID Numbers:
    • CMO-EPI-WH-0618
    First Posted:
    Sep 28, 2020
    Last Update Posted:
    Oct 22, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Leiomyoma

    Study Results

    No Results Posted as of Oct 22, 2020