PANDIA IRIS: Patients With Diabetes and Kidney Failure, an Interdisciplinary Medication Adherence Support Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 3
- 主要终点
- Medication adherence (longitudinal data)
研究概览
简要总结
Monocentric, randomised, controlled and open study. Subjects will be included prospectively and consecutively and randomly assigned into two groups. Intervention group A will benefit a medication adherence support program during 12 months while intervention group B during 6 months only. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visit, the pharmacist will conduct a semi-structured interview in 15 minutes based on Fisher's sociocognitive model with the patients. A summary of the interview and the adherence graph will be send to the patient' health professionals.
详细描述
In addition to usual care, patients are included in a medication adherence support program combining an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd) and motivational semi-structured interviews. This programm is held by the Unisanté's community pharmacists*, in coordination with medical and nurse staff , to support medication adherence and to promote the continuity of care. For patients not speaking french, english, or italian, the interviews will be done with a interpreter.
The medication adherence data will be analysed in both groups along with clinical data obtained through draw samples regularly prescribed by the physician.
*Since the 1st January 2019, the Policlinique Médicale Universitaire became Unisanté, University Center for Primary Care and Public Health (Lausanne, Switzerland).
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
- 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
- •MDRD or CKD-EPI eGFR ≤60 ml/min/1.73m2 or albumin/creatinin >30mg/mmol
- •Type 2 diabetes
- •At least one medication in the following list : oral antidiabetics and/or statins and/or antihypertensive drugs and/or aspirin
- •Patients speaking french, english or italian or interpreter present at each pharmacy visit
- •Patients have to sign the written consent form
- •Patients have to agree to use the Electronic Monitoring system (EM, named MEMS®; Aardex Ltd)
- •Complete laboratory exams in the last 6 months: eGFR and HbA1c and (albumin/creatinin ratio or total cholesterol + LDL + HDL)
排除标准
- •Not being able to understand or sign the consent form
- •Pregnancy
- •Recent cancer diagnosis
- •Cognitive disorder
- •The subject does not manage the treatment alone
研究组 & 干预措施
Intervention group A
Intervention group A will benefit of the medication adherence support program during 12 months. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visits, the pharmacist will conduct an 15 minutes, semi-structured interview based on Fisher's sociocognitiv model with the patients. A summary and the adherence graph will be send to all the involved health professionals
干预措施: Inteprofessional medication adherence support program (IMAP) (Other)
Intervention group B
Intervention group A will benefit of the medication adherence support program during 6 months. Adherence will be monitored using an Electronic Monitoring system (EM, named MEMS®; Aardex Ltd.) during 24 months. At each pharmacy visits, the pharmacist will conduct an 15 minutes, semi-structured interview based on Fisher's sociocognitiv model with the patients. A summary and the adherence graph will be send to all the involved health professionals
干预措施: Inteprofessional medication adherence support program (IMAP) (Other)
结局指标
主要结局
Medication adherence (longitudinal data)
时间窗: 24 months
Implementation and persistance during the intervention phase (6 or 12 months) and during the post-intervention phase (18 months or 12 months)
次要结局
- Patients' satisfaction(At 6 months or 12 months (end of the intervention phase) or at the stop of the study (24 months if the patient ends the study or between the end of the intervention phase (6 months or 12 months) and 24 months.)
- Medication adherence(6 months or 12 months post-intervention phase)
- Clinical outcomes(Baseline, 6 monts and 12 months post-intervention)
研究者
Marie Schneider
Pr. Schneider Marie P., PhD
Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland