Evaluation of the Effectiveness of the Belatacept (Nulojix®) Patient Alert Cards in Patients Following Renal Transplantation in European Economic Area Countries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 8
- 主要终点
- Patient survey: Proportion of patients with correct responses to behavioral questions
研究概览
简要总结
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.
详细描述
3 sub studies: 2 Cross-Sectional and 1 retrospective chart review
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Patient survey: Proportion of patients with correct responses to behavioral questions
时间窗: At patient enrolment
HCP survey: Proportion of HCPs who have utilised the PAC, and the extent of its use
时间窗: 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
时间窗: 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
HCP survey: Mean total score for correct responses
时间窗: Day 1
Patient survey: Proportion of patients treated with belatacept who are aware of the existence of the PAC
时间窗: At patient enrolment
HCP survey: Proportion of HCPs who prescribe or administer belatacept in nephrology centres who are aware of the PAC
时间窗: Day 1
Retrospective chart review study (clinical outcome study): Proportion of serious infections
时间窗: Upto 4 years
Patient survey : Proportion of patients treated with belatacept who have received the PAC
时间窗: At patient enrolment
Patient survey : Proportion of patients who have utilised the PAC, and the extent of its use
时间窗: At patient enrolment
Patient survey: Levels of patient knowledge and comprehension related to the important identified risks of belatacept treatment
时间窗: At patient enrolment
Patient survey: HCP-patient communication based on responses to specific questions
时间窗: At patient enrolment
Patient survey: Mean scores for correct responses for questions grouped by objectives
时间窗: At patient enrolment
Objectives: distribution, awareness, utility, utilization and knowledge
HCP survey: Behavior of HCPs based on responses to behavioral questions
时间窗: Day 1
HCP survey: Mean scores for correct responses for questions grouped by objectives
时间窗: Day 1
Objectives: distribution, awareness, utility, utilization and knowledge
次要结局
- Major determinants of patients knowledge of the key messages contained in the belatacept PAC based on data collected in the patient questionnaire(At patient enrolment)
- Retrospective chart review study (clinical outcome study) : mean time from symptom onset of infection to receipt of medical therapy(Upto 4 years)
- Retrospective chart review study (clinical outcome study) : proportion of infections leading to discontinuation(Upto 4 years)
- Retrospective chart review study (clinical outcome study) : Mean time to diagnosis of graft rejection by biopsy criteria(Upto 4 years)
- Major determinants of understanding the key messages contained in the PAC based on data collected in the patient questionnaire(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(Day 1)
- Major determinants of implementation regarding the key messages contained in the PAC based on data collected in the patient questionnaire(At patient enrolment)