iTRACC (Improving Technology-Assisted Recording of Asthma Control in Children)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 252
- 主要终点
- Asthma Control Test (ACT)
研究概览
简要总结
The goal of this study is to determine whether a sensor-enabled, clinically integrated, mobile health asthma program can improve asthma outcomes among 4-17 year old children with moderate-to-severe asthma.
详细描述
Primary Aims:
- Assess whether asthma control in patients enrolled in the intervention arm improved in comparison to the control arm through the (ACT) measurement tool.
- Assess healthcare utilization (asthma-related ED visits and hospitalizations, asthma-related oral corticosteroid use) obtained through electronic medical record and parent report.
Secondary Aims:
Investigators will use parent-report surveys of the following psycho-social outcome measures:
- Days missed from school due to asthma; 2) pediatric asthma-related quality of life (PACQLQ); and 3) Parental Asthma Management Self-Efficacy (PAMSE).
- Enhance parental management through improved inhaler use. The investigators will use the Propeller Sensor Platform (referenced as Remote Health Management Platform) to allow parents to track their child's ICS and SABA inhaler use daily. The Platform also will have specific educational messaging to help parents and their children achieve adherence to their prescribed plan. This constant feedback and reinforcement may lead to improved asthma control therefore reducing frequency and severity of asthma exacerbations. The investigators will also be assessing the factors associated with the feasibility and sustainability of the Propeller Sensor Platform by observing trends in utilization. Utilization and drop-off will be measured by monitoring use of the inhalers and periodic surveys of families.
- Improve management by the healthcare team. The investigators will use the Remote Health Management Platform to integrate inhaler use data into a web portal that the physician's office can access. Through the development of this interface, the Propeller Sensor Platform will be able to provide inhaler use feedback to healthcare teams.
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
- None
入排标准
- 年龄范围
- 4 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English-speaking parents
- •Children 4-<17 years of age. Using both NHLBI (National Heart, Lung, and Blood Institute) guidelines and based off of a physician expert panel, the research team has limited the ages to 4-<17 years old. It has been shown to be difficult to properly diagnose individuals less than 4 years of age with asthma. Usually, they are diagnosed with reactive airway disease or bronchial virus. Individuals <17 years old was the oldest group because investigators wanted to avoid adolescence and make sure that parents have an active role in the health management of the child.
- •Moderate or severe persistent asthma, defined by the National Heart, Lung, and Blood Institute. This will be done by a physician-trained research assistant who will be able to identify potential participants prior to recruitment.
- •At least one asthma exacerbations that required a course of oral corticosteroids in the past year
- •Prescription and utilization of an ICS inhaler for at least the past year.
- •Who are seen at: Clark and Deming Resident Clinic, Lurie Children's Pulmonary Clinic, Lurie Children's Uptown Clinic, Chicago Family Asthma and Allergy Clinic or Children's Healthcare Associates
排除标准
- •Non-English speaking parents/families
- •Patients seen in the hospital who receive primary care outside of the study's clinics
- •Children with any comorbid conditions, which interfere with appropriate assessment of asthma symptoms: Chronic Lung Disease, Broncho-Pulmonary Dysplasia, Cystic Fibrosis, Pulmonary Hypertension, Interstitial Lung Disease, Immunodeficiency, Bronchiectasis, Primary Ciliary Dyskinesia, Chronic Respiratory Insufficiency, Neuromuscular Weakness, Sickle Cell Lung Disease, Restrictive Lung Disease, and Tracheostomy or Ventilator-dependence
- •Child-patients who are participating in any other research studies that would interfere with our ability to use and track the inhaler sensor
结局指标
主要结局
Asthma Control Test (ACT)
时间窗: 12 month follow-up assessment
Investigators will use the children's Asthma Control Test completed by the caregiver or parent to report child's asthma control. The ACT is a 5 item scale, with a 4-week recall (on symptoms and daily functioning) ACT assesses the frequency of shortness of breath and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control via item-specific response options ranging from 1-5. Total ACT scores range from 5 (poorly controlled asthma, to 25 (well controlled asthma).
12 Month Rate of Medication Use
时间窗: Over a 12 month study period
Number of oral corticosteroid prescriptions obtained from the electronic medical record and parent/caregiver report
Frequency of Asthma-related Hospitalizations
时间窗: the 12 month study period
Number of Asthma-related Hospitalizations during the 12 month study period
Frequency of Urgent Health Utilization
时间窗: the 12 month study period
Number of Asthma-related ED visits during the 12 month study period
次要结局
- Pediatric Asthma Caregiver Quality of Life (QOL) Questionnaire(12 month study follow-up)
研究者
Dr. Deneen Vojta
Executive Vice President, Research and Development, UnitedHealth Group
UnitedHealth Group