Clinical trial NCT02581644: Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries
Official title: Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Transplant
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2015-10-21
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cohort 1: Patient enrolled by physicians based in hospital and physician renal units

Cohort 2: Physicians and nurses based in hospital and physician renal units

Cohort 3: Patient enrolled by physicians based in hospital and physician renal units

Brief summary: The purpose of the study is to determine a) if the implementation of belatacept patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

Detailed description: 3 sub studies: 2 Cross-Sectional and 1 retrospective chart review

Eligibility criteria: Inclusion Criteria:

* Patient survey (cohort 1):
* Patients has taken belatacept within the previous 3 months for renal transplantation
* Patient is over 18 years of age
* HCP survey (cohort 2):
* Physician or nurses working in nephrology centers, with at least 1 patient taking belatacept in the previous 6 months for renal transplantation (by prescribing, administering or by follow up)
* Retrospective chart review study (cohort 3):
* Patient survey questionnaire received, Informed Consent Form (ICF) signed (if required)

Exclusion Criteria:

* Patient survey:
* Patient has participated in a clinical trial for their renal condition in the previous 12 months
* Currently an employee of BMS
* HCP survey:
* Physicians or nurse who have recruited patients for the Patient survey
* Currently an employee of BMS

Primary outcomes:
measure: Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC
timeFrame: At patient enrolment
measure: Patient survey : Proportion of patients treated with belatacept who have received the PAC
timeFrame: At patient enrolment
measure: Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use
timeFrame: At patient enrolment
measure: Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment
timeFrame: At patient enrolment
measure: Patient survey: HCP-patient communication based on responses to specific questions
timeFrame: At patient enrolment
measure: Patient survey: Proportion of patients with correct responses to behavioral questions
timeFrame: At patient enrolment
measure: Patient survey: Mean scores for correct responses for questions grouped by objectives
timeFrame: At patient enrolment
measure: HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC
timeFrame: Day 1
measure: HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use
timeFrame: Day 1
measure: HCP survey: Levels of HCPs' knowledge and comprehension related to the important identified risks of infections and the need to screen for specific infection prior to initiating or administering belatacept
timeFrame: Day 1
measure: HCP survey: Behavior of HCPs based on responses to behavioral questions
timeFrame: Day 1
measure: HCP survey: Mean total score for correct responses
timeFrame: Day 1
measure: HCP survey: Mean scores for correct responses for questions grouped by objectives
timeFrame: Day 1
measure: Retrospective chart review study (clinical outcome study): Proportion of serious infections
timeFrame: Upto 4 years
Secondary outcomes:
measure: Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire
timeFrame: At patient enrolment
measure: Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire
timeFrame: At patient enrolment
measure: Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire
timeFrame: At patient enrolment
measure: Determinants of Health Care Professional (HCP) understanding and implementation regarding key messages contained in the PAC based on data collected in the patient questionnaire
timeFrame: Day 1
measure: Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation
timeFrame: Upto 4 years
measure: Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy
timeFrame: Upto 4 years
measure: Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria
timeFrame: Upto 4 years
Other outcomes:
Locations:
city: Linz
country: Austria
facility: Local Institution
city: Vienna
country: Austria
facility: Local Institution
city: Besançon
country: France
facility: Local Institution
city: Brest
country: France
facility: CHU Brest Hopital La Cavale Blanche
city: Burdeux
country: France
facility: CHU Bordeaux Hopital Pellegrin
city: Clermont-Ferrand
country: France
facility: CHU Clemont Ferrand
city: Créteil
country: France
facility: APHP Hopital Henri Mondor
city: Le Kremlin-Bicêtre
country: France
facility: Local Institution
city: Toulouse
country: France
facility: CHU Toulouse Hopital Rangueli
city: Tours
country: France
facility: CHU Tours Hopital Bretonneau
city: Dresden
country: Germany
facility: Local Institution
city: Kiel
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: UK Mannheim
city: Uppsala
country: Sweden
facility: Local Institution
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References: