SURVEY TO EVALUATE THE KNOWLEDGE AND UNDERSTANDING OF THE KEY SAFETY MESSAGES IN THE HEALTHCARE PROFESSIONAL GUIDE AND THE PATIENT GUIDE FOR SULIQUA

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Post authorization safety study (PASS)

Study drug and medical condition

• Medical condition to be studied:
  Type 2 diabetes mellitus

Population studied

• Short description of the study population:
  HCPs as well as patients/caregivers in 3 waves.; ; Inclusion criteria; The HCP survey will be conducted among HCPs meeting the following inclusion criteria:; 1. HCPs who prescribe/deliver SULIQUA ; ; The patient survey will be conducted among patients (or their caregivers) meeting the following inclusion criteria:; 1. Respondents (patients or caregivers of a patient) who receive SULIQUA; ; Exclusion criteria; HCP survey; The following exclusion criteria will be checked at the beginning of the web questionnaire:; 1. HCPs who are not involved in patient treatment; 2. HCPs who may have conflicts of interest with the survey (i.e. HCPs employed by regulatory bodies, pharmaceutical industries); 3. HCPs who have participated in the previous waves of the survey; 4. HCPs who have already 2 or more colleagues participating in the survey from the same practice in the same wave; ; Patient survey; The following exclusion criteria will be checked at the beginning of the web questionnaire:; 1. Patients (or caregivers) who may have conflicts of interest with the survey; 2. Patients (or caregivers) who have participated in the previous waves of the survey
• Age groups:
  Adults (18 to < 46 years)

  Adults (46 to < 65 years)

  Adults (65 to < 75 years)

  Adults (75 to < 85 years)

  Adults (85 years and over)
• Estimated number of subjects:
  900

Study design details

• Main study objective:
  To assess the knowledge and understanding of the key safety messages in the health care professionals (HCP) and patient guides among HCPs who prescribed or dispensed SULIQUA and patients treated with SULIQUA, respectively.
• Outcomes:
  Correct answers to questions related to key safety messages in the HCP and patient guides.
• Data analysis plan:
  Descriptive analysis will be conducted to calculate the proportions of respondents who provide correct answers to safety related questions

Documents

Study results

rdct-INSLIC08571-study report abstract-PDFA