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临床试验/NCT06094062
NCT06094062已完成不适用

Smartphone App-assisted Discontinuation of Short-term PPI Treatment - an Feasibility Study

University Hospital, Basel, Switzerland4 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
4
主要终点
Patients with PPI treatment over 30 days

研究概览

简要总结

Proton pump inhibitors (PPIs) are frequently prescribed for 30 days but taken infinitely. PPIs belong to the most often inappropriate medicines (PIMs). Correct intake of medicines (named adherence) can be supported by digital devices such as smartphone applications. The goal of this interventional study is to test the feasibility of an app-based treatment support provided by community pharmacists in patients prescribed a short-term PPI (30 days). The intervention consists in tracking medication intake, symptom course and well-being over the treatment duration of 30 days with the mednet app on patients' personal smartphones.

详细描述

This is an exploratory study in a primary care setting with community pharmacists recruiting patients who are newly prescribed a PPI for a short-term treatment (30 days). There is no control group and no randomization. After informed consent and installing the app on their personal smartphones, patients will answer three questions from the app once daily. The questions address medication intake (yes/no), symptom course (better, worse, identical, no symptoms) and well-being (satisfactory/needs improvement). Worsening of symptoms will trigger an alarm (via email) at the pharmacy. The pharmacist will call the patients and use information from adherence and well-being to consolidate a supporting counseling.

Feasibility and a frequency estimation of the interventions will be the focus of the study in view of a larger implementation study with community pharmacies. Further implementation outcomes will be assessed through interviews and surveys (satisfaction, interprofessional work).

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
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

入选标准

  • is ≥18 years old;
  • has symptoms that suggest or correspond to gastroesophageal reflux disease (GERD);
  • is newly prescribed a short-term PPI treatment;
  • accepts to use of the smartphone app mednet during the study period;
  • signs the informed consent form;
  • understands and speaks (Swiss) German.

排除标准

  • in the opinion of the pharmacist or physician, unlikely to comply with the study schedule or are unsuitable for any other reason.

研究组 & 干预措施

Intervention Group

Experimental

干预措施: App-based treatment support (Other)

结局指标

主要结局

Patients with PPI treatment over 30 days

时间窗: 30 days (treatment duration)

Number of patients who started and stopped a PPI after 30 days

次要结局

  • Physicians' and pharmacists' satisfaction with the service(2 weeks after study completion)
  • Patients' satisfaction with the service(2 weeks after the end of treatment)
  • Treatment extensions(30 days (treatment duration))
  • Reliable diagnosis after PPI treatment(After 30 days (treatment duration))

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (4)

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