The Role of Asthma Flare-up Clinic in Improving Management and Outcomes of Asthma
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 230
- 试验地点
- 1
- 主要终点
- Exacerbations
研究概览
简要总结
The goal of this interventional study is to examine the effect of asthma flare-up clinic follow-up in adult subjects after an asthma flare-up. This study aim to answer the following questions:
- Does a follow-up in a flare-up clinic improves disease outcomes?
- Does a follow-up in a flare-up clinic improves disease management?
Participants in the intervention group will take part in a structured follow-up at the asthma flare-up clinic at three time points. Each visit will include questionnaires, pulmonologist examination and consultation, laboratory tests and spirometry. The control group will undergo phone-call follow-up with a research coordinator in similar time frames as the intervention.
Researchers will compare the two groups to see if the clinic follow-up affects the study outcomes.
详细描述
The primary outcomes will be analyzed as total exacerbations during the time frame and as a time-dependent variable (time to exacerbation) using Kaplan Meier survival analysis. Additional sub-analyses will be made for the type of inclusion setting (ED/hospitalization), number of prior exacerbations, and eosinophil count. Additional analyses will be made for all secondary outcomes. Analyses relevant only for the intervention group (such as spirometry and IOS) will compare results to the first follow-up visit. A cost-effectiveness analysis will be made, comparing the follow-up cost and the cost saved by exacerbation reduction based on the final results.
Sample size calculation - The invetigators assume based on previous research that the intervention will lead to a 20% decrease in exacerbations during the 12 months from first follow-up. To achieve an alpha of 0.05 and a power of 80%, there is a need for 88 patients in each group. Assuming a loss-to-follow-up rate (missing to complete at least 2 clinic visits or loss to phone follow-up) of 20%, the study will need 115 patients in each group (230 overall).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prior asthma diagnosis based on clinical and spirometry accepted criteria.
- •Acute exacerbation of asthma as the main reason for ED arrival.
- •Ability to perform in-person and telephone follow-up.
- •Agree to participate, with a signed or verbal informed consent, according to the study group.
排除标准
- •Uncontrolled comorbidity.
- •Cognitive dysfunction.
- •Patients under 18 years or above 75 years.
- •Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibrosis, Churg-Strauss Syndrome, etc) which may impair lung function.
研究组 & 干预措施
Control
The control group will undergo 4 phone-call follow-ups with structured interview based on a predefined questionnaire, at the following time frames - 1, 4, 10, 13, and 19 months after hospital discharge.
Each follow-up call will include:
i. Assessment of ACT score. ii. Whether they attend pulmonologist follow-up visit, additional evaluations (IOS or spirometry), and interventions (pulmonary rehabilitation and smoking cessation programs).
iii. Current treatment. iv. Asthma exacerbations, use of systemic steroids, and relevant management.
Intervention
The intervention will include 3 follow-up visits in the flare up clinic - one month after hospital discharge (from ED or admission), 3 months after the first visit, 6 months after the second visit. At 12 and 18 months after the first visit there will be an additional phone-call with structured interview.
Each clinic visit will include:
i. Pulmonologist examination, review of disease state and care, and adjustment of treatment.
ii. Vital signs (blood pressure, saturation in room air, pulse). iii. Blood sample for complete blood count. iv. Filling Asthma Quality of Life Questionnaire (AQLQ). v. Spirometry. vi. Impulse oscillometry and FeNO tests. vii. Arrangement of next follow-up visit.
干预措施: Follow-up in a flare-up clinic (Other)
结局指标
主要结局
Exacerbations
时间窗: During study follow-up (12 months from inclusion)
The rate of severe asthma exacerbations between the intervention and control, defined as a deterioration of asthma leading to treatment for 3 days or more with systemic glucocorticoids or hospitalization or an emergency department visit leading to treatment with systemic glucocorticoids.
次要结局
- Hospital arrival(During study follow-up (12 months from inclusion))
- Systemic steroids(During study follow-up (12 months from inclusion))
- Asthma control score(During study follow-up (12 months from inclusion))
- Quality of life score(During study follow-up (12 months from inclusion))
- Time to first exacerbation(During study follow-up (12 months from inclusion))
- Time to first hospital arrival(During study follow-up (12 months from inclusion))
- Time to first systemic steroids use(During study follow-up (12 months from inclusion))
- Clinical remission(During study follow-up (18 months from inclusion))
- Extended clinical remission(During study follow-up (18 months from inclusion))
- Percentage of Participants with errors of inhaler use technique(During study follow-up (18 months from inclusion))
- Percentage of Participants with a change in treatment(First clinic visit (1 month after inclusion))
- Adherent to treatment guidelines(During study follow-up (18 months from inclusion))
- Percentage of Participants with treatment compliance(During study follow-up (18 months from inclusion))
- Change in spirometry variables(During study follow-up (12 months from inclusion))
- Change in FeNO results(During study follow-up (12 months from inclusion))
- Change in area of reactance using IOS(During study follow-up (12 months from inclusion))
- Change in resonant frequency using IOS(During study follow-up (18 months from inclusion))
- Changes in respiratory resistance at 5 Hz, 20 Hz and the difference between 5 and 20 Hz using IOS(During study follow-up (12 months from inclusion))
- Changes in reactance at 5 Hz using IOS(During study follow-up (12 months from inclusion))