此页面是自动翻译的，不保证翻译的准确性。请参阅英文版对于源文本。

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

2017年6月14日更新者：Bristol-Myers Squibb

Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries

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.

研究概览

地位

完全的

条件

肾移植

详细说明

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

研究类型

观察性的

注册 (实际的)

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

奥地利
- - Linz、奥地利、A-4020
    - Local Institution
  - Vienna、奥地利、A-1090
    - Local Institution
德国
- - Dresden、德国、1307
    - Local Institution
  - Kiel、德国、24105
    - Local Institution
  - Mannheim、德国、68167
    - UK Mannheim
法国
- - Besançon、法国、25030
    - Local Institution
  - Brest、法国、29200
    - CHU Brest Hopital La Cavale Blanche
  - Burdeux、法国、33000
    - CHU Bordeaux Hôpital Pellegrin
  - Clermont-Ferrand、法国、63000
    - CHU Clemont Ferrand
  - Créteil、法国、94000
    - APHP Hôpital Henri Mondor
  - Le Kremlin-Bicêtre、法国、94270
    - Local Institution
  - Toulouse、法国、31059
    - CHU Toulouse Hopital Rangueli
  - Tours、法国、37000
    - Chu Tours Hopital Bretonneau
瑞典
- - Uppsala、瑞典、75185
    - Local Institution

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

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

描述

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Patients survey Adult patients treated with belatacept for renal transplantation
HCP survey HCP with at least 1 patient taking belatacept
Retrospective chart review study Adult patients treated with belatacept for renal transplantation

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Patient survey: Mean scores for correct responses for questions grouped by objectives 大体时间：At patient enrolment	Objectives: distribution, awareness, utility, utilization and knowledge	At patient enrolment
HCP survey: Mean total score for correct responses 大体时间：Day 1		Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives 大体时间：Day 1	Objectives: distribution, awareness, utility, utilization and knowledge	Day 1
Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC 大体时间：At patient enrolment		At patient enrolment
Patient survey : Proportion of patients treated with belatacept who have received the PAC 大体时间：At patient enrolment		At patient enrolment
Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use 大体时间：At patient enrolment		At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment 大体时间：At patient enrolment		At patient enrolment
Patient survey: HCP-patient communication based on responses to specific questions 大体时间：At patient enrolment		At patient enrolment
Patient survey: Proportion of patients with correct responses to behavioral questions 大体时间：At patient enrolment		At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC 大体时间：Day 1		Day 1
HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use 大体时间：Day 1		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 大体时间：Day 1	The percentage of HCPs with responses to each question in the HCP questionnaire that would indicate effectiveness of the PAC will be determined: who are aware of the PAC, use the PAC, level of knowledge and comprehension of the risks and mean scores for correct responses	Day 1
HCP survey: Behavior of HCPs based on responses to behavioral questions 大体时间：Day 1		Day 1
Retrospective chart review study (clinical outcome study): Proportion of serious infections 大体时间：Upto 4 years		Upto 4 years

次要结果测量

结果测量	措施说明	大体时间
Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire 大体时间：At patient enrolment	Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept	At patient enrolment
Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire 大体时间：At patient enrolment	Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept	At patient enrolment
Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire 大体时间：At patient enrolment	Determinants: Age, gender, educational level, number of prescription medications, duration of therapy with belatacept	At patient enrolment
Determinants of Health Care Professional (HCP) understanding and implementation regarding key messages contained in the PAC based on data collected in the patient questionnaire 大体时间：Day 1	Determinants: type of HCP, country, age and gender of HCP years in specialty, number of HCPs in the unit, annual number of patients through the unit, number of patients for whom belatacept was prescribed in the previous 12 months, type of practice, type of institution (academic or non-academic), size of town	Day 1
Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation 大体时间：Upto 4 years		Upto 4 years
Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy 大体时间：Upto 4 years		Upto 4 years
Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria 大体时间：Upto 4 years		Upto 4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bristol-Myers Squibb

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年11月29日

初级完成 (实际的)

2017年5月19日

研究完成 (实际的)

2017年5月19日

研究注册日期

首次提交

2015年9月28日

首先提交符合 QC 标准的

2015年10月20日

首次发布 (估计)

2015年10月21日

研究记录更新

最后更新发布 (实际的)

2017年6月16日

上次提交的符合 QC 标准的更新

2017年6月14日

最后验证

2017年6月1日