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临床试验/NCT03248895
NCT03248895已完成不适用

Evaluation of a Mobile Direct Observation Therapy (DOT) Approach in Children and Young People With Asthma. Pilot Study

Queen's University, Belfast0 个研究点目标入组 22 人开始时间: 2015年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
22
主要终点
Number of asthma attacks

研究概览

简要总结

Mobilte Direct Observation Therapy (MDOT) is a technology has the potential to be a cost effective approach to direct observation of therapy administration, the latter being one of the most accurate methods of evaluating adherence. Use to date, as confirmed by the rapid systematic review, has been limited mainly to TB and sickle cell disease and there have been no published reports on the use of MDOT to monitor inhaled therapy. Due to the increasing incidence of childhood asthma worldwide, there is a need for new innovative approaches to support children and their parents with asthma management, especially since national and international guidelines have advised healthcare providers to periodically assess inhaler use as part of asthma management.

详细描述

Asthma is the most common chronic disease in childhood. It is defined as a chronic inflammatory disorder of the airways in which many cells and cellular elements promote airway obstruction and hyper-responsiveness (GINA, 2012). According to the World Health Organization (WHO, 2014), asthma is estimated to affect approximately 253 million people worldwide. Despite advances in biological and pathological research, the prevalence of asthma in children has significantly increased over the past decade (Massingham et al., 2014).

Moreover, the economic burden of asthma is increasing. In the US, it is estimated that the yearly cost of asthma in children and adults is around $1.48 billion (Price et al., 2013). A decade ago, the total annual asthma expenditure in the UK was determined to be £752.6 million with 8% of costs associated with hospital admission, 13% attributable to general practitioner consultations and 79% due to prescription costs (Gupta et al., 2004).

The British Thoracic Society (BTS/SIGN, 2012) and Global Initiative for Asthma (GINA, 2012) guidelines provide the background definitions for three broad categories of asthma control. They include controlled (no nocturnal wakening, infrequent short acting beta 2 agonist (SABA) use e.g. < 2 puffs/week, occasional mild symptoms e.g. with exercise and no exacerbations in last 3 months), partially controlled (nocturnal wakening < 3 nights/week, SABA use e.g. < 4 puffs/day, mild limitation in exercise tolerance due to asthma, and 2 or fewer mild exacerbations in the previous 3 months) or uncontrolled (nocturnal wakening 4-7 nights/week, SABA use e.g. > 5 puffs/day, limitation in exercise tolerance due to asthma and or significant asthma exacerbations requiring oral steroid, Emergency Department attendance or hospital admission in the previous 3 months). Children who present with partially controlled or uncontrolled asthma can be divided into difficult to treat asthma (DTA) and true severe therapy resistant asthma (STRA) after careful investigation (Hedlin et al., 2012). DTA occurs when asthma is uncontrolled but the impact of concomitant disorders and the basics of asthma care (inhaler technique and adherence) have not been adequately resolved.

Many children with asthma can achieve symptom and disease control by using inhaled corticosteroid (ICS) therapy combined with a long acting B2 agonist (LABA) and/or a leukotriene receptor antagonist (LTRA) (International ERS/ATS guideline, 2014). However, a number of children with asthma experience frequent symptoms despite being prescribed high dose ICS (Nagakumar and Thomas, 2013; Hedlin et al., 2014).

Drug delivery by inhalation of various medications is the most common treatment approach for asthma in all patient populations. Inhalation therapy offers rapid onset and improved efficacy compared to systemic drug delivery (Bisgaard, 1997). While ICS therapy is well accepted as the foundation of optimal therapy for most asthma patients, efficacy of the therapy depends on drug being delivered correctly into the lungs and taken on a regular basis as a preventer therapy (Machira et al., 2011).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
2 Years 至 16 Years(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Children and young people aged from 2-16 years with apparent partially controlled or uncontrolled DTA. The children will have asthma symptoms despite being prescribed ICS (> 400 mcg/day for children < 5 years, 800 mcg/day for children > 5 years) and a second line therapy such as a LABA, LTRA, or theophylline (Nagakumar and Thomas, 2013).
  • •One member of the household has access to a smartphone, tablet or other mobile device that is capable submitting a video image to an internet accessible repository. This person must have access to the device for the entire period of the intervention phase (6 weeks) of the study.

排除标准

  • •Children whose asthma symptoms are controlled.
  • •Children and/or parents without access or unwilling to allow use of a suitable mobile device for the study.

研究组 & 干预措施

Immediate (I-med)

Active Comparator

Participants allocated to the I-med group will take part in the mobile DOT intervention for the first 6 weeks. Outcomes will be evaluated at the start (week 0) and end of the 6 week intervention period and during clinic visits at weeks 12 and 18 for follow-up

干预措施: Mobile Direct Observation of Therapy (MDOT) (Device)

Delayed (D-med)

Active Comparator

Those participants allocated to the D-med group will have the DOT intervention started after a 6 week "intervention-free" interval with usual Asthma Clinic care. Outcomes in the D-med group will be assessed at baseline (week 0), week 6 (intervention start), week 12 (end of intervention), and at weeks 18 and 24 for follow-up.

干预措施: Mobile Direct Observation of Therapy (MDOT) (Device)

结局指标

主要结局

Number of asthma attacks

时间窗: Recruitment - 18 weeks post intervention

Number of attacks taken during follow-up period

Oral corticosteroids courses

时间窗: Recruitment - 18 weeks post intervention

Numbers of courses of oral corticosteroids taken during follow-up period

Self reported Medication Adherence Report Scale (MARS)

时间窗: Recruitment - 18 weeks post intervention

Parent/guardian completes MARS if child younger than 9yrs old

Interview-administered Paediatric Asthma Quality of Life Questionnaire (PAQOLQ) or Paediatric Asthma Caregiver Quality of Life Questionnaire (PACQOLQ)

时间窗: Recruitment - 18 weeks post intervention

PAQOLQ if 9 years or older; PACQOLQ if under 9

Interview-administered Asthma Control Test (ACT) or Childhood Asthma Control (C-ACT)

时间窗: Recruitment - 18 weeks post intervention

ICS inhaler technique

时间窗: Recruitment - 18 weeks post intervention

Clinician assessment of asthma control

时间窗: Recruitment - 18 weeks post intervention

Clinician assessment of degree of disease control recorded at baseline and during follow-up period

Asthma medication profile

时间窗: Recruitment - 18 weeks post intervention

Current medication profile and any changes made

Attendances at Emergency Department (ED)

时间窗: Recruitment - 18 weeks post intervention

Numbers of attendances to ED during follow-up period

Clinician assessment of asthma severity

时间窗: Recruitment - 18 weeks post intervention

Clinician assessment of asthma severity recorded at baseline and during follow-up period

Spirometry measurement; Fraction of exhaled nitric oxide (FeNO)

时间窗: Recruitment - 18 weeks post intervention

Measurements taken at each intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

James McElnay

Professor

Queen's University, Belfast

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