Effectiveness of a Web-based, Digital Health Platform Combining Social Care and Respiratory Coach Support to Improve Adherence to Treatment and Symptom Control in Children and Adolescents with Difficult-to-control Asthma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Differences in asthma control inter-group
研究概览
简要总结
Asthma is the most common chronic respiratory disease worldwide. Despite advances in asthma management, control of the disease is still a challenge especially among children. Information and communications technology (ICT) have been recently used in clinical practice to increase awareness of diseases, encourage patients to engage in the management of their conditions and improve monitoring and surveillance. The investigators of this study will test a new digital platform combining online/offline content aimed to improve asthma control and reduce exacerbations and unnecessary consultations in children with difficult-to-control asthma. A randomised controlled trial enrolling 60 patients allocated in two groups has been designed. The intervention group (IG) will be granted free access during 6 months to a web-based platform. During this period, patient will have access to online/off line content to improve disease awareness, monitor signs and symptoms and will also get the support of a respiratory coach. In addition, patients in this group will receive an electronic peak flow meter to register daily variations in maximal expiratory flow and an electronic device to connect to their inhaler to track adequate intake of inhaled medication. The control group (CG) will receive usual care consisted of scheduled visitations to medical doctors every 4 - 8 weeks. Both groups will be evaluated at baseline, post-intervention (6 months) and at follow up (one year) in the following variables: age, gender, asthma severity classification according to international guidelines, date of diagnosis, weight, height, Body Mass Index (BMI), forced expiratory volume in 1 second (FEV1), Asthma Control Test (ACT) score, treatment received for asthma, number of exacerbations in the previous 6 months and concomitant diseases. Exacerbations will be defined as any worsening in asthma symptoms that requires an increase in the usual therapy, an unscheduled physician visit, treatment in the emergency room or hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
盲法说明
The statistical analyses will be performed by one researcher unaware of patient allocation
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children between 6 and 18 years old;
- •diagnosis of moderate to severe persistent asthma according to the international guidelines
- •difficult to control asthma according to a scoring in the Asthma Control Questionnaire (ACQ) of 1.5 points or Asthma Control Test (ACT) ≤19;
- •access to internet and a smartphone, tablet or computer;
- •ability to understand and use the web-based platform (in children <12 years the ability of the tutor or legal guardian);
- •informed consent (by the tutor or legal guardian)
排除标准
- •patients who have had an exacerbation in the previous two weeks;
- •patients with intermittent asthma and/or well-controlled asthma according to the Asthma Control Questionnaire (ACQ) score of <1.5 or Asthma Control Test (ACT) score ≥20;
- •any neurological or psychiatric condition that prevents patients to use adequately the platform.
研究组 & 干预措施
Intervention Group
Participants in the IG will be given free access to the HappyAir platform during a 6-month period. This platform combines online/offline content to help patients with chronic respiratory diseases monitor their symptoms and improve self-management. In addition to tailored information on their condition, participants will be encouraged to fill in daily data on their physical activity levels, symptomatology, use of rescue medication and mood. In children under 12 years, parents or caregivers will fill in this information. Patients will be asked to record their peak expiratory flow using an electronic peak flow meter twice daily. Every patient will be assigned a respiratory coach who will monitor patient during the study and whom the patients can contact at any time.
干预措施: Happyair Ecosystem (Behavioral)
Control Group
Subjects in the CG will receive standard care consisting of periodic visitations at the Allergology or Paediatric Pulmonology Unit in their respective hospitals every 4 - 8 weeks according to their physician's criteria. In addition, patients and caregivers in both groups will receive one educational session regarding the correct use of their inhalers.
结局指标
主要结局
Differences in asthma control inter-group
时间窗: 12 months
Differences in asthma control (score) will be calculated according to the Asthma Control Test (ACT) in comparison with the control group. The ACT consists of five items that are rated according to a five-point scale where where 1 means poor control and 5 indicates better asthma control.
Differences in asthma control inter-group
时间窗: 6 months
Differences in asthma control (score) will be calculated according to the Asthma Control Test (ACT) in comparison with the control group. The ACT consists of five items that are rated according to a five-point scale where where 1 means poor control and 5 indicates better asthma control.
次要结局
- Inclusion rates (feasibility)(Baseline)
- Completion rates(12 months)
- Incidence of exacerbations(12 months)
- Changes in lung function (FEV1)(12 Months)
- Changes in lung function (PEF)(12 Months)
- Changes in lung function (FEV1)(6 Months)
- Changes in lung function (PEF)(6 Months)
研究者
Raquel Sebio
Physiotherapist
Hospital Clinic of Barcelona