Improvement of Medicine Adherence and the Following Positive Effects on Transplants in Patients After Organ Transplantation With Pilloxa's Electronic Pillbox
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Adherence to medication
研究概览
简要总结
Poor adherence to medication among patients with chronic diseases is a major problem. A patient group where the adherence to prescribed medications is extremely important are organ transplanted patients. It is well established that lack of adherence to immunosuppressive medication drastically increases the risk of rejection reactions, graft loss and deaths.
Pilloxa is a device meant to help users manage medication and support adherence to medication. This study evaluates if Pilloxa improves adherence to treatment for transplanted patient compared with conventional management. Patients who have received a transplanted kidney or liver will be studied.
Pilloxa is a system comprising of: a box with 14 separate containers to temporarily store tablets/capsules in and that can be open by 14 independent lids, a smartphone application and cloud based servers. The pillbox will at given times detect if pills are present in the different compartments and can connect, send and receive information to/from mobile application and the cloud.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
The analysis is blinded. The statistician will not have access to the affiliation of the users until the statistical analysis of the study data is finalised.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient had an organ (liver or kidney) transplanted.
- •Patient who wishes to participate in the study and who is able to understand, read, write and give written informed consent in the Swedish or English language. For persons under the age of 18, the guardians must understand, read, write and give written informed consent in the Swedish or English language.
- •Ongoing daily immunosuppressive medication that is expected to continue during the study period.
- •Handles medication by herself or, in the case of children, that medication is handled by the guardian.
- •The patients doses of immunosuppressants fits into the chambers of the product.
- •The patient's medicine ordination is not expected to change more often than once weekly.
- •Owns and uses a compatible smartphone, option for underage children that guardians hold a compatible smartphone.
排除标准
- •Suffers from dementia, neurological disease or other cognitive impairment which causes problems in understanding instructions or managing medication independently.
- •Physical inability to use the product as intended.
结局指标
主要结局
Adherence to medication
时间窗: During 6 months
The proportion of days with adherence to medication for each patient. Adherence is defined as taking drugs within the interval within 120.0 minutes before to 120.0 minutes after each prescribed dose.
次要结局
- Organ rejection(During 6 months)
- Graft Function - Bilirubin(Clinical routine sampling during 6 months)
- Graft Function - ALP(Clinical routine sampling during 6 months)
- Serious Adverse Events and Adverse Events(During 6 months)
- Graft Function - Gamma-GT(Clinical routine sampling during 6 months)
- Graft survival and patient survival(During 6 months)
- Concentration of Tacrolimus(Clinical routine sampling during 6 months)
- Graft Function - Creatinine(Clinical routine sampling during 6 months)
- Graft Function - eGFR(Clinical routine sampling during 6 months)
- Graft Function - ASAT(Clinical routine sampling during 6 months)
- Quality of Life(At 6 months compared to baseline)
- User-friendliness(At 6 months)
- Graft Function - ALAT(Clinical routine sampling during 6 months)
- Graft Function - INR(Clinical routine sampling during 6 months)