Patient Education After Lung Transplantation Via Tablet Computers Versus Conventional Education - a Randomized Open Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 2
- 主要终点
- Calcineurin trough levels
研究概览
简要总结
Experimental intervention:
Patient education after lung transplantation via Tablet computers. An electronic patient questionnaire via tablet computer will be collected in addition.
Control intervention:
Conventional Patient education by health care professionals. A paper-based patient questionnaire will be provided.
详细描述
Noncompliance with immunosuppressive medications after organ transplantation is thought to be a leading cause of allograft rejection, graft loss, and death. Immunosuppressant medy to prevent graft rejection after lung transplantation.
Reported non-compliance rates with calcineurin inhibitors are ranging between 13 and 22 % after lung transplantation. Incidence of non-compliance increases over time after transplantation. Increased health care costs, decreased quality of life, and organ failure (incl. the need for re-do transplantation) are possible consequences of immunosuppressant noncompliance. Therefore, medication compliance defined as the extent to which a patient's medication taking behaviour coincides with the prescribed regimen, is a critical issue in transplantation. Repeated patient education is one option to overcome non-adherence and immunosuppressive medication non-compliance.
Immunosuppressive therapy is monitored by measurement of drug levels. Fluctuating drug levels increase the risk for rejection and drug toxicities. In addition, frequent dose adjustments, case management and frequent monitoring of drug levels are cost-intensive.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients at least 6 months after lung transplantation (single, double or combined)
- •Informed consent
- •At least 10 trough levels analyzed in MHH reference lab in last 6 months
- •< 50% of calcineurin inhibitor trough levels in target range in last 6 months in outpatient clinic
排除标准
- •Hospitalization during last 3 months
- •BOS stage 3 (FEV1 < 50% baseline)
- •End stage kidney disease (GFR <15 ml/min/1.73 m2 or renal replacement therapy)
- •Oxygen requirement at rest
- •Steroid pulse therapy (>500 mg methylprednisolone per day) during the last 4 weeks
- •Illiteracy
- •Need for isolation (Colonization with multi. or pan resistant organisms, e.g. MRSA, B. cenocepacia)
- •limited German language skills or other reasons which might impair patient communication or computer handling
结局指标
主要结局
Calcineurin trough levels
时间窗: 6 month
Improvement of percentage of calcineurin inhibitor trough levels (Delta %) in target range 6 months after patient education compared to 6 months before patient education
次要结局
- Calcineurin trough levels variability(6 month)
- Interval Adherence(6 month)
- Trough level interval(6 month)
- Total time of education(6 month)
- Total time of answering questionnaire(6 month)
- Knowledge Improvement(6 month)
- Self rated adherence(6 month)
- Adherence(6 month)
- Glomerular filtration rate(6 month)
研究者
Thomas Fuehner
MD
Hannover Medical School