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

A Cross-sectional Study Among Healthcare Professionals in Canada to Assess Awareness and Knowledge of the Fibristal Additional Risk Minimization Measures

Status

Withdrawn

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04567589

Enrollment

Registered

2020-09-28

Start date

2020-09-30

Completion date

2021-02-28

Last updated

2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Fibroids

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).

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

OTHER

Eligibility

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 .
Percenatage of HCPs that recall distributing the Fibristal Patient Alert Card	18 - 24 months	HCP's recall of distributing the Fibristal Patient Alert Card
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
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.

Countries

United States

Outcome results