Study of Drug Acceptance and Its Persistence Over Time in Patients Receiving a Haematopoietic Stem Cell Allograft: a Pilot Study at the University Hospital of Limoges
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Factors associated with a change
研究概览
简要总结
Allograft patients have a complex care pathway and are left with a large number of prescribed medications.
They have to deal with changes linked to the transplant (change in taste, fatigue, regular monitoring, risk of GVH (graft versus host) complications, infectious risks, change in eating habits, etc.), and a large number of associated drugs (immunosuppressants, anti-infectious prophylaxis and supplements (folic acid, magnesium, bile salts, etc.), which are added to any pre-existing chronic pathologies.
Therapeutic adherence of these patients is a real challenge. Indeed, the success of the transplant and the complications that may arise (graft rejection, GVH, infections, death, hospitalisation, etc.) are closely linked to good or poor therapeutic adherence. Moreover, the majority of these patients are young and are not used to taking many treatments, which will change after the transplant.
Adherence to treatment consists of three phases:
- Acceptance of the disease and the benefits of treatment,
- Compliance: following the instructions of the prescription (dosage and schedule),
- Persistence: consistency of compliance over time.
Support from the care team throughout the management of these patients is necessary for good therapeutic adherence in order to prevent and act early on the difficulties encountered (appearance of side effects linked to the treatments, large number of tablets per day, duration of treatment (1 to 2 years), risk of GVH, significant asthenia and difficulty in concentrating, etc.)
We have a large amount of data on therapeutic adherence and potential non-adherence factors in patients with chronic diseases (diabetes, asthma, cancer, etc.) or in solid organ transplant patients.
On the other hand, there is little data on allograft patients. Most often, a parallel is made between the data present in kidney transplant patients and allograft patients. However, it is necessary to study more specifically the therapeutic adherence in this population.
A recent multicentre cross-sectional study in France on adherence in allograft patients showed that 80% of adult and paediatric patients were not adherent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •allograft patients followed by the Limoges University Hospital
排除标准
- •patient hospitalised at the Limoges University Hospital for a reason other than allograft
- •refusal of the patient to participate in this research
- •patient unable to understand the treatment
- •pregnant or breastfeeding woman
研究组 & 干预措施
Experimental
干预措施: pharmaceutical follow-up (Other)
结局指标
主要结局
Factors associated with a change
时间窗: month 12
Semi-structured interview conducted at M+12 post-transplant.
Medication adherence level
时间窗: month 12
Patient's level of medication adherence will be assessed by the 8-item Morisky test (score 0 to 13 : a score greater than or equal to 11 show good adherence)
次要结局
- Medication adherence level(month 9)
- Factors associated with a change(month 9)
- Representation of the information given on transplant drugs according to the health professionals accompanying the transplant patient(month 12)
- Patient's representations of their medication after transplantation(month 12)