GeoAsma: Pilot and Evaluation of a Clinical Decision Support System and a Mobile App for the Management of Asthma Patients.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 214
- 试验地点
- 1
- 主要终点
- Number of exacerbations Number of exacerbations
研究概览
简要总结
GeoAsma is a study for the definition, validation and evaluation of predictive models on the influence of the environment on asthmatic patients in Andalusia.
详细描述
Although for decades there have been multiple studies on the association of asthma with factors such as weather conditions, pollution, pollen and the social condition of patients, the GeoAsma project aims to advance the study of environmental factors that influence the health of asthmatic patients by combining BigData technology and data mining analysis, Geographic Information Systems and open data provided by official sources with data from the Electronic Health Record of the Andalusian Health System, that provides healthcare services to more than 8,000,000 citizens.
This project aims to study through data mining techniques and multilevel analysis the influence of clinical and environmental factors: pollen level, air pollution, atmospheric conditions and social determinants in more than 800,000 asthmatic patients during the last 15 years in Andalusia, the southernmost region of Spain. It is expected that the results of this study will serve to define predictive models that will help professionals and patients in our region to make decisions.
After the validation of the models, a decision support system will be implemented in a web platform and in a mobile application. Its impact on the reduction of exacerbations, control, quality of life and resource consumption of asthmatic patients will be analysed. This evaluation will be carried out through a pilot with 214 patients with a follow-up period of 12 months with asthma in the hospitals participating in this proposal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with bronchial asthma in its intermittent and persistent degrees mild/moderate.
- •No respiratory infections in the month prior to testing.
- •Availability and/or ability to use a Smartphone.
排除标准
- •Severe persistent asthmatics.
- •Pregnant women, breastfeeding women or women who want to become pregnant during the duration of the study.
- •Subjects with malignant disease, uncontrolled risk factors or any pathology that compromises the safety of the study.
- •Treatment with systemic corticosteroids during the 6 months prior to or during the study.
- •Subjects with problems that limit their ability to cooperate.
- •Subjects unable to perform correct spirometric maneuvers.
研究组 & 干预措施
Intervention group
Clinicians will use a Clinical decision support system to better manage their patients. Asthmatic patients will use a smartphone app for their self management.
干预措施: Clinical Decission support system management & mobile App Intervention Group (Other)
Control
Asthmatic patients that will not be subject to any intervention
结局指标
主要结局
Number of exacerbations Number of exacerbations
时间窗: 1 year
Measured by the number of times the patient goes to the emergency room or uses rescue medication and/or cycles of oral corticosteroids.
Health-related quality of life
时间窗: 1 year
The Asthma Quality of Life Questionnaire (AQLQ) will be administered at baseline, 3 and 6 months of the study. The AQLQ contains 32 items corresponding to 4 dimensions of health: limitation of usual activities, symptoms, emotional function, and environmental stimuli.
Immune response
时间窗: 1 year
IgE test, lymphocite count
Treatment adherence
时间窗: 1 year
Estimated through dispensations
Asthma control
时间窗: 1 year
The Asthma Control Test is a validated determination of asthma control that is directly control of asthma that is answered directly by the patient and consists of five questions questions that assess: activity limitations, dyspnea, nocturnal symptoms, rescue medication use, and the patient's overall rating of asthma control. symptoms, use of rescue medication, and the patient's overall rating of asthma control over the previous four weeks, which is defined from the results of a questionnaire.
Quality-adjusted life year
时间窗: 1 year
To calculate this index, the EuroQol-5D quality of life questionnaire will be administered at baseline, three and six months into the study. The EQ-5D describes health status with five dimensions (mobility, self-care, activities of daily living, pain/discomfort, and anxiety/depression), each of which is defined with three levels of severity. It also consists of a millimetered Visual Analog Scale (VAS) on which the subject must score his or her health status on the day of the survey, with the extremes of the scale being the worst imaginable health status (0) and the best imaginable health status (100).
Patient satisfaction
时间窗: 1 year
It will be carried out at the end of the study by means of a questionnaire that includes items on ease of use, usefulness, intention to use, etc.
Respiratory function
时间窗: 1 year
Several pulmonary function tests will be carried out. These tests will include spirometry (FEV1, FVC, FEV1/FVC ratio, PC20, PD15, Fractional exhaled nitric oxide)
次要结局
- Economic evaluation(1 year)
研究者
Alberto Moreno Conde
PHD Alberto Moreno Conde
Hospital Universitario Virgen Macarena