Influence of Inhaler Compliance on the Treatment of Asthma Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- compliance ratio
研究概览
简要总结
The major goal of "Influence of Inhaler Compliance on the Treatment of Asthma Patients" is to explore compliance rate outcome in adult asthmatic patients (20-80 years old) with mild to moderate persistent asthma according to American Thoracic Society (ATS) definition and diagnosis. The major endpoints include:
- To increase the adherence rate of treatment by reminder intervention with correctly monitor patients' adherence rate by Asthma Supportive Kits
- Eventually achieve best asthma care and management.
All participants will use Asthma Supportive Kits for 24 weeks and return visit on week 5, 12, 24. Based on collected data, the study compares intervention and control group to see if active reminder intervention may effectively alter compliance rate, and corresponding outcomes, e.g., asthma control status, acute exacerbation events.
详细描述
- Upon enrollment, the all patients will be educated and equipped with asthma supportive kits, which is a electronic device attaches to an MDI medicine.
- The asthma supportive kit registers every puff taken when the patient uses his/her MDI. The records are monitored by study nurses and calculated compliance ratio on rolling basis.
- By enrollment, the patient is RANDOMLY assigned to Intervention and Control group. For the Intervention group in each study phases, when the given compliance ratio drops below 80% (as monitored by asthma supportive kit), the study nurse will actively engage to remind on medicine taking. For the Control group, the compliance ratio is calculated but to active engagement is applied.
- All the patients adheres with regular asthma treatment mechanism, regardless to group assigned.
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
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult asthmatic patients (20-80 years old)
- •With mild to moderate persistent asthma according to ATS definition and diagnosis
- •Willing to use Budesonide+Formoterol.
- •Adequately use inhaler
- •Without evident intentional non-adherence
- •Agree asthma is a common and potentially serious chronic disease
- •Willing to sign Informed Consent Form
排除标准
- •Inadequately use inhaler
- •Disagree asthma is a common and potentially serious chronic disease
- •With uncontrolled systemic diseases, such as hypertension, heart failure, renal failure, de-compensated liver cirrhosis, etc.;
结局指标
主要结局
compliance ratio
时间窗: 28 day
Compliance Ratio: 1. the Compliance Ratio evaluates the ratio of days which the patient is taking equal (or greater than) puffs of medicine as instructed by physician with the past 28-days. 2. the outcome ratio ranges from 0% (none of days is taking correct amount) to 100% (all past 28 days were taking correct amount).
Asthma Control Test Score
时间窗: 28 day
Asthma Control Test (ACT) Score: 1. the ACT is a patient self-administrated tool for identifying those with poorly controlled asthma; 2. the test includes 5 items to recall past 4-week symptoms and daily functioning; 3. The scores range from 5 as poorly controlled to 25 as completely controlled of asthma
次要结局
未报告次要终点