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临床试验/NCT02386722
NCT02386722已完成不适用

Impact of a Pharmaceutical Care Intervention to Improve Adherence of Inhaled Medication in Asthma and COPD Patients

Cantonal Hosptal, Baselland4 个研究点 分布在 1 个国家目标入组 169 人开始时间: 2014年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
169
试验地点
4
主要终点
Time to Next Asthma or COPD Exacerbation up to 182 Days

研究概览

简要总结

Despite progress in pharmacological and non-pharmacological treatment in recent years, the burden of disease among asthma and COPD patients is high and patients may be frequently hospitalized due to exacerbations. Reasons for uncontrolled disease are manifold, but are frequently associated with poor inhalation technique and non-adherence to the prescribed treatment plan which may cause substantial mortality, morbidity, and cost to the healthcare system. In this respect, the study of causes for non-adherence and the development of measures to increase respectively maintain treatment adherence, particularly in chronic diseases, is of major clinical importance.

The aim of this study was to investigate the impact of an acoustic reminder and a close supervision on adherence to inhaled medication and on course of disease and quality of life (Qol) in asthma and COPD patients.

In this single-blinded trial, asthma and/or COPD patients were randomly assigned either to the intervention or the control group. Adherence to inhaled medication was monitored using electronic data capture devices, recording date and time of each inhalation device actuation. Follow-up was six months. Primary outcome was defined as "time to next exacerbation". Secondary outcomes included number of exacerbations, number of exacerbations with hospitalization, taking/timing adherence, and Qol during follow-up. Adherence was measured using electronic data capture devices which saved date and time of each inhalative device actuation. Patients are randomly assigned to an intervention, respectively control group. Patients assigned to the intervention group will receive audio reminder and support calls in case medication is not been taken as prescribed or if rescue medication is used more frequently than prespecified in the study protocol. During the study, participants are assessed every two months.

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 (Participant)

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

  • Aged 18 years or older
  • Have an established asthma-diagnosis according to the Global Initiative for Asthma (GINA) guidelines and/or
  • Have an established COPD diagnosis according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines (severity GOLD I-IV based on the international GOLD-Criteria) [46] and
  • Are prescribed daily inhaled medication (controller medication for a daily maintenance treatment)
  • Had at least one exacerbation in the previous 12 months before study start
  • With a metered dose Inhaler (e.g. Ventolin®), Diskus (e.g.Seretide®), Turbohaler (e.g.Symbicort®), Aerolizer/Breezhaler (e.g.Onbrez®), HandiHaler (e.g. Spiriva®) or Ellipta (e.g Relvar®)

排除标准

  • Suffering from malignancies and/or other severe diseases
  • Insufficient in the German language
  • Pregnant or lactating

结局指标

主要结局

Time to Next Asthma or COPD Exacerbation up to 182 Days

时间窗: 182 days

The primary outcome of this study was "time to next asthma or COPD exacerbation", defined as acute-onset worsening of the patient's condition beyond day-to-day variations requiring interaction with a healthcare provider. It was expressed as the number of exacerbations since the last visit with the exact period of exacerbation also including the number of exacerbations requiring hospitalisation. The first exacerbations during the study period served as reference to calculate the primary endpoint "time to next exacerbation".

次要结局

  • Percentage of Gaps for Dry Powder Capsules (Breezhaler, Handihaler), Assessed by POEMS.(180 days)
  • Numbers of Days of the Longest Period of Time Without Inhalation During the Investigated Time Period(180 days)
  • Number of Days of the Longest Period of Time Without Inhalation.(180 days)
  • Score of the St. George Respiratory Questionnaire(180 days)
  • Percentage of Gaps in Puff Inhaler Use(180 days)
  • Percentage of Days of Adherence(180 days)
  • Percentage of Days With Timing Adherence(180 days)
  • Number of Exacerbations.(180 days)
  • Number of Severe Exacerbations.(180 days)
  • Adherence to Puff Inhalers(180 days)
  • Percentage of Days With Adherence to Dry Powder Capsules (Breezhaler and Handihaler) Assessed by POEMS(180 days)

研究者

发起方
Cantonal Hosptal, Baselland
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof. Dr. Jörg Leuppi

Head University Clinic of Internal Medicine, Canton Hospital Baselland

Cantonal Hosptal, Baselland

研究点 (4)

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