Assessment of Feasibility and Effectiveness of Remote Asthma Management Via an Integrated Artificial Intelligence-assisted Clinical Decision Support System With Mobile Device Compared With Usual Asthma Care in Pediatric Participants With Asthma Aged 6-17 Years: A Parallel Group, Non-blinded, Dual-site, 2-arm, Pragmatic Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 49
- 试验地点
- 2
- 主要终点
- Change in satisfaction of asthma care
研究概览
简要总结
The main purpose of this study is to look at whether clinicians and their patients with asthma can satisfactorily perform remote asthma management at home (not visiting clinic) by using an artificial intelligence tool called Asthma-Guidance and Prediction System combined with a home monitoring device called AsthmaTuner.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinician participants are eligible to be included in the study only if all of the following criteria apply:
- •Employed as consultant or nurse practitioner at study sites.
- •Able to provide written consent.
- •Are willing to follow recommendations to schedule/see participant and their caregiver for regular asthma follow-up care every 3-6 months.
- •All asthma care coordinators who are involved in the usual care of pediatric participants will also be recruited for inclusion in the study.
- •Pediatric participants are eligible to be included in the study only if all of the following criteria apply:
- •Ages 6-17 years old with diagnosis of asthma.
- •Have a caregiver who is willing to participate alongside pediatric participant and to have regular asthma follow-up care every 3-6 months.
- •Adolescent participants ages 13-17 years and their caregivers are able to give written informed consent; or child participants ages 7-12 years are able to provide assent and their caregivers are able to give written informed consent (subjects who are 6 years old will be waived).
- •Both participant and caregiver are able to read and write in English.
- •Receive pediatric primary care at study sites from participating study clinician.
- •Access for caregiver and/or adolescent participants to an Android or iPhone with Wi-Fi access and availability for at least monthly use.
- •Active asthma defined by at least one clinic visit with a diagnosis of asthma per EHR or on active asthma control or rescue medication in the past 12 months. Priority will be given to those with persistent asthma on inhaled corticosteroids therapy or those with poorly controlled asthma defined by any of the following criteria in the past 12 months, except item v (past 2-week period); i. Asthma Control Test for adolescents ≥ 12 years or Childhood Asthma Control Test for children < 12 years (score< 20); ii. ED visit for asthma; or iii. Hospitalization for asthma; or iv. Unscheduled outpatient visit for asthma requiring oral corticosteroid use; or v. Asthma symptoms at the screening interview, including 1) more than 2 days per week shortness of breath, wheezing, chest tightness, or 2) more than 1 night awakening due to asthma in the past 2-week period.
- •Participant had their latest asthma follow-up visit more than 3 months prior to the screening date of the study.
排除标准
- •Pediatric participants who do not meet the eligibility criteria described above will be excluded and those will be excluded from the study if any of the following criteria apply:
- •Major medical problems prohibiting study participation and inability to perform study procedures (including spirometry); suspected symptoms of exercise-induced laryngeal obstruction (EILO), tracheobronchial foreign body at or about the incidence date of asthma, wheezing occurring only in response to anesthesia or medications, bullous emphysema or pulmonary fibrosis on chest radiograph, PiZZ alpha1-antitrypsin, cystic fibrosis, or other major chest disease such as severe kyphoscoliosis or bronchiectasis.
- •Pediatric participant pregnancy.
- •Hyposensitization therapy for > 3 months prior to study enrollment.
- •Participation in any other interventional studies for asthma within 1 month prior to study.
研究组 & 干预措施
Pediatric Asthma Intervention Group
Along with clinical standard of care for asthma, subjects will have Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) integrated into care.
干预措施: Asthma-Guidance and Prediction System (Other)
Clinician Intervention Group
Clinicians will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma.
干预措施: AsthmaTuner (Device)
Asthma Care Coordinator Intervention Group
Asthma Care Coordinators will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma.
干预措施: AsthmaTuner (Device)
Pediatric Asthma Intervention Group
Along with clinical standard of care for asthma, subjects will have Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) integrated into care.
干预措施: AsthmaTuner (Device)
Pediatric Asthma Control Group
Subjects will receive clinical standard of care for asthma.
Clinician Control Group
Clinicians will provide clinical standard of care for pediatric asthma patients.
Asthma Care Coordinator Control Group
Asthma Care Coordinators will provide clinical standard of care for pediatric asthma patients.
Clinician Intervention Group
Clinicians will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma.
干预措施: Asthma-Guidance and Prediction System (Other)
Asthma Care Coordinator Intervention Group
Asthma Care Coordinators will integrate Asthma-Guidance and Prediction System (A-GPS) with AsthmaTuner (AT) into clinical standard of care for asthma.
干预措施: Asthma-Guidance and Prediction System (Other)
结局指标
主要结局
Change in satisfaction of asthma care
时间窗: Baseline, 6 months
Measured by single question to assess satisfaction about asthma care using a Likert scale where 1=strongly disagree and 5=strongly agree. Higher score indicates greater satisfaction.
Change in Satisfaction of Asthma Care
时间窗: Baseline, 6 months
Measured by a single question to assess satisfaction about asthma care using a Likert scale where 1=strongly disagree and 5=strongly agree. Total scores range from 1 to 5, with higher scores indicates greater satisfaction.
次要结局
- Frequency of poorly controlled asthma(Baseline, 6 months)
- Number of on-site visits(6 months)
- Time allocated to asthma visits(6 months)
- Estimated Clinician Preparation Time for Asthma Visits(6 Months)
- Change in the Number of Subjects With Poorly Controlled Asthma(Baseline, 6 months)
- Number of On-site Visits(6 months)