Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02581644
• Date of registration: 28/09/2015
• Prospective Registration: Yes
• Primary sponsor: Bristol-Myers Squibb
• Public title: Assessment of Effectiveness of Belatacept Patient Alert Card in Patients Following Renal Transplantation in a Sample of EU Countries
• Scientific title: Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries
• Date of first enrolment: November 29, 2016
• Target sample size: 63
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02581644
• Study type: Observational
• Phase: N/A

Countries of recruitment

Austria, France, Germany, Sweden

Contacts

• Name: Bristol-Myers Squibb
• Affiliation: Bristol-Myers Squibb

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Renal Transplant

Primary Outcome(s)

Patient survey : Proportion of patients treated with belatacept who have received the PAC [Time Frame: At patient enrolment]

Patient survey: Mean scores for correct responses for questions grouped by objectives [Time Frame: At patient enrolment]

Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use [Time Frame: At patient enrolment]

Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment [Time Frame: At patient enrolment]

Patient survey: Proportion of patients with correct responses to behavioral questions [Time Frame: At patient enrolment]

HCP survey: Mean total score for correct responses [Time Frame: Day 1]

HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC [Time Frame: Day 1]

HCP survey: Mean scores for correct responses for questions grouped by objectives [Time Frame: Day 1]

HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use [Time Frame: Day 1]

Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC [Time Frame: At patient enrolment]

Patient survey: HCP-patient communication based on responses to specific questions [Time Frame: At patient enrolment]

Retrospective chart review study (clinical outcome study): Proportion of serious infections [Time Frame: Upto 4 years]

HCP survey: Behavior of HCPs based on responses to behavioral questions [Time Frame: Day 1]

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 [Time Frame: Day 1]

Secondary Outcome(s)

Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria [Time Frame: Upto 4 years]

Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire [Time Frame: At patient enrolment]

Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation [Time Frame: Upto 4 years]

Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy [Time Frame: Upto 4 years]

Determinants of Health Care Professional (HCP) understanding and implementation regarding key messages contained in the PAC based on data collected in the patient questionnaire [Time Frame: Day 1]

Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire [Time Frame: At patient enrolment]

Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire [Time Frame: At patient enrolment]

Secondary ID(s)

IM103-367

Source(s) of Monetary Support

Please refer to primary and secondary sponsors