Pharmacotherapy Follow-up of a Randomized Cohort to Monitor Patients With Asthma on Well-defined Treatment Using a Self-management Mobile Application
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Asthma Control at 4 weeks
研究概览
简要总结
Asthma is a chronic inflammatory disease that affects the lungs. In Brazil it is responsible for about 4 to 8 deaths per day. Pharmacotherapeutic follow-up programs for people with asthma have a positive impact on treatment adherence, as well as on education about the disease, helping patients in their self-management and recognition of their health status. The use of mobile applications that assist in the monitoring and self-management of people with asthma has been increasing significantly, but we do not have much information about their real impact on the control of the disease. Thus, the aim of this study is to evaluate the use of a mobile application in the monitoring and self-management of symptoms in adults with asthma in a pharmaceutical care program at a university outpatient clinic in São Paulo, Brazil.
详细描述
Study design: interventional study
Patients will be selected according to eligibility criteria and after having agreed and signed an informed consent form, they will be randomized into one of the arms of the study.
At the inclusion visit, demographic data, health history, medication history and allergy history will be collected. They will be evaluated regarding the level of asthma control using the ACQ-6 instrument, as well as the ability to use inhaled medications. They will receive the relevant guidelines regarding the activities that will be carried out during the study.
In both arms, patients will be followed up in a 12-week pharmacotherapeutic follow-up program, where they will have to record weekly three measurements of peak expiratory flow and fill out a questionnaire to assess the control on paper (control group) or fill out a risk score for exacerbation contemplated in the mobile application, which the pharmacist will have access through a web platform (intervention group). Depending on the evolution of each patient, the pharmacist will provide the relevant guidelines to improve control, as well as referral to a medical care service, if applicable.
During the study, a follow-up visit will be carried out and, at the end of the 12 weeks, a closing visit, where will be evaluated the need for medical support during the period, the use of systemic corticosteroids, access to control treatment, the occurrence of adverse event, review of pharmacotherapy and inhalation technique.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Having a diagnosis of asthma and being under medical follow-up for at least six months;
- •Meet at least one of the following criteria: a) Have had at least one (01) exacerbation in the last 12 months; b) Have used oral corticosteroids in the last three months; and/or c) Being using high doses of inhaled corticosteroid (budesonide > 800 mcg/day; fluticasone > 500 mcg/day; or beclomethasone > 400 mcg/day - pressurized HFA gas-based device or >1000 mcg/day - other devices).
- •Understand, agree and sign the Free and Informed Consent Term.
排除标准
- •Illiterate patients or patients with cognitive deficits;
- •Patients not fluent in Portuguese;
- •Patients without mobile device skills;
- •Patients who do not have mobile devices with Android® 6.0 operating system.
结局指标
主要结局
Change in Asthma Control at 4 weeks
时间窗: 4 weeks after the inclusion visit
The evolution of asthma control will be evaluated through repeated measures of a validated control assessment questionnaire (control arm) or by the risk of exacerbation score contemplated in the cell phone application (application arm)
Change in Asthma Control at 12 weeks
时间窗: 12 weeks after the inclusion visit
The evolution of asthma control will be evaluated through repeated measures of a validated control assessment questionnaire (control arm) or by the risk of exacerbation score contemplated in the cell phone application (application arm)
Occurrence of exacerbations
时间窗: Up to study completion, an average of 12 weeks
Assessment of the number of occurrences of severe exacerbations that required medical support.
次要结局
未报告次要终点
研究者
Rafael Stelmach
Collaborating Professor
University of Sao Paulo General Hospital