Sensor: ENhancing aSthma carE - An Observational Prospective Study to Characterize Patients Initiating Indacaterol + Glycopyrronium Bromide + Mometasone Furoate (Enerzair® Breezhaler®), With or Without Sensor, as a Maintenance Treatment for Asthma
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- clinical characteristics - asthma-related hospitalizations
研究概览
简要总结
This is an observational, descriptive, open-label, prospective, 6-month study including a group of patients with a first prescription of IND/GLY/MF with sensor and a group with a first prescription of IND/GLY/MF without sensor.
详细描述
Patients will be invited prospectively and sequentially to participate in the study when attending a participating community pharmacy with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor. Therefore, the invitation for the patient to participate in the study will occur only after the therapeutic decision has taken place
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged ≥18 years
- •Self-reported diagnosis of asthma
- •Individual filling a first prescription of IND/GLY/MF with or without sensor in a participating community pharmacy for himself/herself (excluding caregivers).
- •Individual capable and willing to perform the study assessments.
排除标准
- •No exclusion criteria.
结局指标
主要结局
clinical characteristics - asthma-related hospitalizations
时间窗: Baseline
Number of hospitalizations: * n of hospitalizations * Don't know/Don't answer
Baseline sociodemographic - educational level
时间窗: Baseline
Patient's highest completed educational level: * None * I - Basic education (4 years) * II - Basic education (6 years) * III - Basic education (9 years) * Upper secondary education or equivalent (12 years) * Bachelor/ University Degree * Don't know/Don't answer
clinical characteristics - body mass index
时间窗: Baseline
body mass index will be provided
clinical characteristics - smoking status
时间窗: Baseline
Patient smoking status: * Never smoked * Ex-smoker * Smoker * Don't know/Don't answer
clinical characteristics - TAI score
时间窗: Baseline
The TAI questionnaire was developed to measure self-reported adherence to inhaler devices and help clinicians to evaluate non-adherence barriers related to inhaled therapy in adult patients with asthma or chronic obstructive pulmonary disease. The interpretation of adherence based on the 10-item TAI, scoring is that an overall score of 50 points highlights good adherence, while a score of between 46 to 49 points denotes intermediate adherence. A total score ≤ 45 points indicates poor adherence
Baseline sociodemographic - living status
时间窗: Baseline
Assess if the patient lives alone: * Yes * No * Don't know/ Don't answer
clinical characteristics - comorbidities
时间窗: Baseline
Patient comorbidities: * Allergic rhinitis * Rhinosinusitis * Allergic conjunctivitis * Sleep disorders * Anxiety * Depression * Other. Specify
clinical characteristics - duration of disease
时间窗: Baseline
duration of disease will be provided
clinical characteristics - age at asthma diagnosis
时间窗: Baseline
Age when asthma was diagnosed: * Years * Unknown/cannot remember
clinical characteristics - emergency admissions and non-scheduled visits in the previous 12 months
时间窗: Baseline
Number of appointments: * number of scheduled asthma physician's appointments * number of unscheduled asthma physician's appointments * Don't know/Don't answer
clinical characteristics - ACT score
时间窗: Baseline
The Asthma Control Test (ACT) contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control)
clinical characteristics - last asthma treatment
时间窗: Baseline
International Nonproprietary Name (INN) of Last asthma medication
Baseline sociodemographic - household income
时间窗: Baseline
Patient's household net income level: * \<665 € * \[665€ to 1000€\[ * \[1000€ to 1200€\[ * \[1400€ to 1700€\[ * \[1700€ to 2000€\[ * \[2000€ to 2700€\[ * ≥2700€ * Don't know/Don't answer
Baseline sociodemographic - employment status
时间窗: Baseline
Patient Employment status: * Employed. Number of hours per week. * Unemployed * Student * Retired * Other. Specify. * Don't know/Don't answer
次要结局
- Changes from baseline in self-reported adherence - TAI questionnaire score(Baseline, month 3, month 6)
- Adherence from the app (percentage)(Month 3, month 6)
- Asthma control from the app (category)(Month 3, month 6)
- percentage of patients reporting ease to use and understand how to use the sensor and the app in the group of IND/GLY/MF with sensor(month 3, month 6)
- Reasons for discontinuation and treatment switch(month 3, month 6)
- Change from baseline in number of work hours/days missed(Baseline, month 3, month 5)
- Changes from baseline in self-reported adherence - asthma control test (ACT) score(Baseline, month 3, month 6)
- Percentage of patients in treatment(month 3, month 6)
- Percentage of patients by level of treatment satisfaction(month 3, month 6)
- Percentage of patients who downloaded the app in the group of IND/GLY/MF with sensor.(month 3, month 6)
- percentage of patients with a valid app report in the group of IND/GLY/MF with sensor.(month 3, month 6)
- Change from baseline in number of hospitalizations(Baseline, month 3, month 6)
- Change from baseline in number of emergency room visits(Baseline, month 3, month 6)
- Percentage of patients with desire to continue using sensor/app in the group of IND/GLY/MF with sensor.(month 3, month 6)
- Percentage of patients with fair acquisition value for sensor/app in the group of IND/GLY/MF with sensor(month 3, month 6)
- Rescue medication from the app(Month 3, Month 6)
- Change from baseline in number of scheduled and non-scheduled medical visits(Baseline, month 3, month 6)
- percentage of patients reporting usefulness of the sensor/app reports in asthma control and treatmen in the group of IND/GLY/MF with sensor.t(month 3, month 6)