Adherence to Airway Clearance. Novel Approaches to Improving Adherence
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence to therapy
研究概览
简要总结
An airway clearance technique (ACT) is one of the core treatments for children with chronic lung diseases who are unable to clear their secretions effectively. Unfortunately adherence to performing an ACT is low with a reported rate between 40 - 70%. Up to the present, there has been no way to objectively measure adherence to an ACT. With new technology, it is now feasible to connect an electronic manometer to an airway clearance device to objectively measure how often the child is actually performing their ACT. The first part of this proposed study is to objectively measure adherence against reported adherence over a 4 month period. During the second 4 months a video game will be added to the digital manometer which only operates if participants are performing their ACT properly. Adherence will again be measured.
详细描述
Background:- Airway clearance using an airway clearance technique (ACT) is one of the core treatments for children with chronic lung diseases such as cystic fibrosis, periciliary dyskinesia, and non-CF bronchiectasis who are unable to clear their secretions effectively. One of the most frequently used ACTs is called positive expiratory pressure (PEP) which uses a mask to produce a back pressure in the lungs getting air behind the mucus to mobilize it up the airways. Unfortunately adherence to performing an ACT is low with a reported rate between 40 - 70%. Up to the present, there has been no way to objectively measure adherence to an ACT. However, with new technology, it is now feasible to connect an electronic device to the PEP mask to objectively measure how often the child is actually performing their ACT. This proposed study would be the first study to objectively measure adherence against reported adherence.
Purpose:
- To objectively measure adherence, using an electronic manometer attached to a PEP mask, against reported adherence.
- Secondly, to objectively measure adherence after connecting the electronic manometer to an age appropriate video game designed to operate only if the PEP mask is used properly.
The hypothesis is that actual adherence is lower than reported adherence, and that by using a video game as a feedback mechanism while performing PEP, adherence will be improved.
Methodology:-20 subjects with either a diagnosis of cystic fibrosis or non CF bronchiectasis, between the ages of 6 - 12 years old will be recruited into this study. Subjects will be their own control, in that their reported adherence will be measured against their actual adherence. After enrollment, subjects will be provided with an electronic device which connects to the pressure port of their PEP mask. They will be told that the device attached to the PEP Mask pressure port will measure pressure. Subjects will be asked to continue using their PEP Mask as prescribed for 4 months referred to as period one. During this time the electronic device will collect data on pressure and how often and when the PEP mask is used. In addition the subject or parent will be asked to keep a log book of when and how often they did their PEP Mask.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Bronchiectasis either by chest-radiograph or a high resolution computerized tomography; or cystic fibrosis diagnosed by sweat test using a quantitative method or a genotype with two identifiable CF mutations.
- •Age, between 6 - 12 years of age and be competent in spirometry.
- •Have been using PEP Mask as their primary airway clearance technique for the previous 3 months.
- •Willingness to adhere to prescribed treatment regimen.
- •Clinically stable with no evidence of a respiratory exacerbation within a month of enrollment as assessed by a site Physician.
排除标准
- •Diagnosis of Allergic Broncho-Pulmonary Aspergillosis, or a persistent culture for B.cepacia complex within the previous 1 year period.
- •On active treatment for non-Tuberculous Mycobacterium
- •Use of intravenous antibiotics within the previous 30 days of enrollment.
- •Initiation and or change in maintenance therapy within 30 days of enrollment.
- •Use of systemic corticosteroids (1mg/kg if < 20 kg or 20 mg of prednisone per day) within 14 days of enrollment.
- •Concurrent participation in another study that could potentially affect the present study.
- •Presence of a condition or abnormality that in the opinion of the site Physician would compromise the safety of the patient or the quality of the data.
研究组 & 干预措施
Reported adherence
During a 4 month period the investigators will measure adherence to therapy as reported in a daily diary by participants against actual adherence which will be measured by a digital manometer attached to the participants therapy device which uploads real time data to the cloud.
Adherence with a video game
During the second 4 month period, participants will be given a video game on a tablet which is operated through the digital manometer by their performing their therapy correctly.Actual adherence will be measure again during this time and be compared to the no intervention arm
干预措施: Video game (Device)
结局指标
主要结局
Adherence to therapy
时间窗: Continually collected in real time commencing at enrollment to the study and finishing at completion of the study which is 8 months.
Actual adherence will be measured using a digital device attached to the participants airway clearance device which uploads real time use to a database on the web.Thus this outcome is assessed on a continual basis throughout the 8 months of the study. No further data will be collected on adherence after the study is completed at 8 months.
次要结局
- Pulmonary function(Pre and post each 4 month period beginning at time of enrollment and completing at end of study, approximately 8 months. There is no data collection post study following the end of the 8 month study period.)
研究者
Maggie McIlwaine
Clinical Associate Professor
University of British Columbia