Prospective Study of the Feedback From an Adherence Monitor on Asthma Control (INCA)
Inhaled medications are the mainstay of the therapeutic management of respiratory disorders. Considered by many to be 'simple' and 'easy' to use, clinicians are aware that inhalers are often improperly used. However, there is no tool that can detect and record errors in either the timing or the method dose administration
The investigators designed a device that makes an acoustic record each time an inhaler is used. Opening the device makes an acoustic file which is recorded, this file is "time-stamped" which means that the timing of drug administration is recorded. When the device is retrieved and acoustic analysis performed, the steps involved in using the inhaler can be determined. Hence, the subjects inhaler technique is assessed and errors in the inhaler use identified. Together this means that errors in inhaler technique and timing of use can be quantified.
In this study the investigators attached the device to a discus dry powder inhaler. In order to eliminate the behavioral component of adherence and identify the mechanical issues associated with effective inhaler use the investigators studied subjects who were already in Hospital and already prescribed a discus inhaler. The investigators hypothesized that the device would identify which errors in technique were the most common and that this would provide insight into how these errors might be eliminated.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Dublin、爱尔兰、Dublin 9
- Beaumont Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients prescribed therapy equivalent to step 3 or higher on the Asthma Management Guidelines for at least 3 months
- At least one exacerbation in the previous year with systemic glucocorticoids
- Uncontrolled/Partially Controlled Asthma by GINA guidelines
Exclusion Criteria:
- Allergy to salmeterol/fluticasone
- Patients Controlled by GINA guidelines
学习计划
研究是如何设计的?
设计细节
- 主要用途:卫生服务研究
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器:Active Feedback
In this arm patients will receive monthly review and education on inhaler technique and use based on a computer download of their last month of inhaler use
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The inhaler will be fitted with a device that makes an audio recording of the inhaler use.
This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly.
This information will be discussed with the patient.
其他名称:
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安慰剂比较:Control
In this arm patients will be reviewed monthly, however will not have information from INCA device to tailor inhaler education.
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The inhaler will be fitted with a device that makes an audio recording of the inhaler use.
This audio data will be downloaded to a computer program, analyzed for assessment of whether the steps involved in using the inhaler have been performed correctly.
This information will be discussed with the patient.
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Adherence rate
大体时间:at three months
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The rate of actual adherence at baseline and at the end of the study, which at the end of the 3 month of study will be assessed.
The actual inhaler adherence, expressed as cumulative drug exposure, is calculated by combining the time of use along with the interval between doses (correct time is twice a day, in a period not less than 6 hours between the last dose and the subsequent dose or at a time greater than 18 hours apart from the previous dose.)
and incorporating, by audio analysis, if the inhaler was used correctly.
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at three months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Asthma quality of life score
大体时间:at 3 months
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The asthma quality of life score will be related to adherence, The baseline asthma quality of life score and the quality of life score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
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at 3 months
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Peak Expiratory Flow Rate
大体时间:at 3 months
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The peak expiratory flow rate will be related to adherence, The baseline peak expiratory flow rate and the peak expiratory flow rate at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
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at 3 months
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Asthma Control Test
大体时间:at 3 months
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The asthma control test score will be related to adherence, The baseline asthma control test score and the score at the end of three months will be subtracted and these will be correlated with the average rate of adherence over the three months.
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at 3 months
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Asthma Exacerbations
大体时间:over 3 months
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The frequency in exacerbations over the three months will be compared between the active and control arms.
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over 3 months
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Asthma Reliever Medication Use
大体时间:over 3 months
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The change in frequency of reliever use per month from baseline to the end of the study will be compared between active and control patients.
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over 3 months
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合作者和调查者
调查人员
- 首席研究员:Richard Costello, MD、Beaumont Hospital
出版物和有用的链接
一般刊物
- Chan A, De Simoni A, Wileman V, Holliday L, Newby CJ, Chisari C, Ali S, Zhu N, Padakanti P, Pinprachanan V, Ting V, Griffiths CJ. Digital interventions to improve adherence to maintenance medication in asthma. Cochrane Database Syst Rev. 2022 Jun 13;6(6):CD013030. doi: 10.1002/14651858.CD013030.pub2.
- Sulaiman I, Greene G, MacHale E, Seheult J, Mokoka M, D'Arcy S, Taylor T, Murphy DM, Hunt E, Lane SJ, Diette GB, FitzGerald JM, Boland F, Sartini Bhreathnach A, Cushen B, Reilly RB, Doyle F, Costello RW. A randomised clinical trial of feedback on inhaler adherence and technique in patients with severe uncontrolled asthma. Eur Respir J. 2018 Jan 4;51(1):1701126. doi: 10.1183/13993003.01126-2017. Print 2018 Jan.
- Sulaiman I, Seheult J, MacHale E, Boland F, O'Dwyer SM, Rapcan V, D'Arcy S, Cushen B, Mokoka M, Killane I, Ryder SA, Reilly RB, Costello RW. A Method to Calculate Adherence to Inhaled Therapy that Reflects the Changes in Clinical Features of Asthma. Ann Am Thorac Soc. 2016 Nov;13(11):1894-1903. doi: 10.1513/AnnalsATS.201603-222OC.
- Sulaiman I, Mac Hale E, Holmes M, Hughes C, D'Arcy S, Taylor T, Rapcan V, Doyle F, Breathnach A, Seheult J, Murphy D, Hunt E, Lane SJ, Sahadevan A, Crispino G, Diette G, Killane I, Reilly RB, Costello RW. A protocol for a randomised clinical trial of the effect of providing feedback on inhaler technique and adherence from an electronic device in patients with poorly controlled severe asthma. BMJ Open. 2016 Jan 4;6(1):e009350. doi: 10.1136/bmjopen-2015-009350.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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