Evaluation of the effectiveness of the belatacept (Nulojix®) Patient Alert Card in patients following renal transplantation in European Economic Area countries.

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Effectiveness study (incl. comparative)
• Data collection methods:
  Combined primary and secondary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Healthcare professional survey, patient survey, retrospective chart review study

Study drug and medical condition

• Study drug International non-proprietary name (INN) or common name:
  BELATACEPT
• Medical condition to be studied:
  Renal transplant

Population studied

• Short description of the study population:
  Patients/HCPs with responses to each question that indicate effectiveness of the belatacept (Nulojix®) Patient Alert Card (PAC).
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with renal transplantation
• Estimated number of subjects:
  70

Study design details

• Main study objective:
  The main objective of the study is to evaluate the effectiveness of the belatacept patient alert card (PAC) in renal transplantation patients via three epidemiological sub-studies: a patient survey, a healthcare professional (HCP) survey and a clinical outcomes study using retrospective chart review.
• Outcomes:
  Patient survey: proportion of correct responses to individual questions about receipt, knowledge, understanding and acting on the advice contained in the belatacept PAC.HCP survey: proportion of correct responses to individual questions about understanding and implementation of key messages contained in the PAC.Clinical outcomes study: proportion of serious infections. Patient survey:determinants of patient knowledge and understanding and implementation of the key messages. HCP survey:determinants of HCP understanding and implementation of the key messages. Clinical outcomes study:proportion of infections leading to discontinuation, mean time from symptom onset of infection to receipt of medical therapy and mean time from transplantation to graft rejection.
• Data analysis plan:
  For the patient and HCP questionnaires, the percentage of patients/HCPs with responses to each question that indicate effectiveness of the PAC will be determined: receipt, awareness, usage, knowledge and comprehension of key messages. The primary endpoints of the patient survey responses indicating understanding and implementation will be analysed by baseline patient characteristics. The primary endpoints of the HCP survey responses indicating understanding and implementation of the PAC will be analysed by baseline HCP characteristics. Correlation between patients’ degree of understanding and implementation of the messages in the PAC with serious infections and other secondary endpoints will be studied through regression techniques.