Inhaler Technique Education in Elderly Patients With Asthma or COPD: Impact on Disease Exacerbations - a Protocol for a Single-blinded Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 146
- 主要终点
- Adverse events
研究概览
简要总结
Introduction COPD and Asthma affect more than 10% of the population. Most patients use their inhaler incorrectly, mainly the elderly, thereby becoming more susceptible to poor clinical control and exacerbations. Placebo device training is regarded as one of the best teaching methods, but there is scarce evidence to support it as the most effective one to improve major clinical outcomes. Our objective is to perform a single-blinded RCT to assess the impact of this education tool in these patients.
Methods and Analysis A multicentre single-blinded RCT will be set, comparing a placebo-device training programme versus usual care, with a one-year follow-up, in elderly patients with Asthma or COPD. Intervention will be provided at baseline, and after 3 and 6 months, with interim analysis at an intermediate time point. Exacerbation rates were set as primary outcomes, and quality of life, adherence rates, clinical control and respiratory function were chosen as secondary outcomes. A sample size of 146 participants (73 in each arm) was estimated as adequate to detect a 50% reduction in event rates. Two-sample proportions Chi-squared test will be used to study primary outcome and subgroup analysis will be carried out according to major baseline characteristics.
Discussion The investigators expect to confirm that inhaler performance education will significantly reduce exacerbation rate and improve clinical and functional control.
Ethics and dissemination:
Every participant will sign a consent form. A Data Safety Monitoring Board will be set up to evaluate data throughout the study and to monitor stop earlier criteria. Identity of all participants will be protected. Results will be presented in scientific meeting and published in peer-reviewed journals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Blinding for the investigator that acess outcomes, that will not be involved in the intervention process.
入排标准
- 年龄范围
- 65 Years 至 130 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of COPD or Asthma, medicated with any kind of inhaler device (pressurized Metered Dose Inhaler (pMDI) with or without Spacer, Dry Powder Inhaler (DPI) or Soft Mist), aged ≥65 years and being a regular user of primary health care services (defined as having at least one consultation performed in the last two years with his/her own Family Doctor). In order to minimize diagnostic inaccuracy, Asthma and COPD diagnosis will be reviewed in every participant at baseline prior to enrolment and according to GINA and GOLD strategies.
排除标准
- •Severe or acute illness (such as unstable cardiovascular status, unstable angina, recent myocardial infarction (within one month) or pulmonary embolism, haemoptysis of unknown origin, recent pneumothorax (within one month), recent thoracic, abdominal or eye surgery (within one month), acute nausea or vomiting, severe respiratory distress, dementia). Patients with intermittent asthma, as well as COPD patients with mild obstruction (GOLD class I) will be excluded, since these patients do not need to take inhaler medication on a daily basis, and tend to have a low frequency of disease exacerbations.
研究组 & 干预措施
Inhaler technique education
This group will receive a structured and regular follow-up plan, with education on inhaler technique. Patients will be trained by a Family Doctor (the primary investigator) in terms of the inhaler technique using placebo devices similar to their own devices. A teach-to-goal approach will be used, repeating all correct steps as many times as needed in order for patients to perform them correctly at each evaluation. There will be visits at baseline and after 3, 6 and 12 months to assess outcomes. In each visit, and prior to the main intervention with the primary investigator, assessment of the inhaler technique and application of all questionnaires (clinical control, treatment adhesion and quality of life) will be performed by a secondary blinded investigator.
干预措施: Inhaler technique education (Behavioral)
Usual Care
This group will receive usual care from their own Family doctors, with no specific intervention. Each doctor will perform the necessary consultations according to his real life judgment. Besides this, this group will perform visits at baseline and after 3, 6 and 12 months to assess secondary outcomes. At each visit, assessment of the inhaler technique and application of all questionnaires (clinical control, treatment adhesion and quality of life) will be performed by a secondary blinded investigator. At any appointment, if the patient asks for or if the clinician decides to teach inhaler technique, that will be recorded.
If any adjustments are made in drug classes or device types in every participants, this information will be recorded.
结局指标
主要结局
Adverse events
时间窗: Evaluation at 12 months.
This outcome will be quantifyed as "time to event" For Asthma, an event will be defined as increased respiratory clinical symptoms leading the patient to search for medical care, and resulting in any of the following: * Need for increased inhaled corticosteroid dose of at least 4x the regular dose * Need for increase of short-acting β2 agonists on a daily basis * Need for oral corticosteroids * Need for oral antibiotics * Hospitalization or Emergency Room (ER) visit with increased respiratory clinical symptoms. For COPD, an event will be defined as increased respiratory clinical symptoms inducing the patient to search for medical care, and resulting in any of the following: * Need for increase of long-acting β2 agonists on a daily basis * Need for oral corticosteroids * Need for oral antibiotics * Hospitalization or ER visit with increased respiratory clinical symptoms. Respiratory-related mortality and all-cause mortality will also be considered an adverse event.
次要结局
- Adherence rate(Evaluation at 12 months.)
- Inhaler technique performance(Evaluation at 12 months.)
- Clinical assessment(Evaluation at 12 months)
- Quality of Life(Evaluation at 12 months.)
- Functional control(Evaluation at 12 months.)
研究者
Tiago Maricoto
Principal Investigator
Aveiro-Aradas Family Health Unit