Remote Patient Monitoring Solution for Chronic Respiratory Disease Management
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Euro Quality of Life 5 dimensions (EQ5D)
研究概览
简要总结
Aim: To evaluate the use of AeviceMD Monitoring System (AeviceMD) asthma in reducing acute exacerbation.
Methodology: Using a randomized controlled trial design, this project aims evaluate the effectiveness of AeviceMD in improving patients' outcomes in terms of reducing exacerbation, healthcare utilization, improving quality of life, self-efficacy, and cost effectiveness. Paediatric patients above age 7 and adults will be recruited. The data follow-up period is 3 months. It will also evaluate the usability of the device from both patients' and clinicians' perspective. 180 patients (124 adults, 56 pediatrics) and 120 clinicians will be recruited.
Importance of study: This study will evaluate if the AeviceMD can help improve disease management and reduce recurrence of asthma exacerbation.
Potential benefits and risk: AeviceMD allows for remote monitoring and tracking of patients' lung sounds, which could be used by patients to monitor their lung condition and prevent an episode of exacerbation or worsening exacerbations culminating in an admission which who further utilize already limited healthcare resources. An exacerbation is an episode of severe shortness of breath, cough, and chest tightening which warrants a visit to a healthcare institution. Through self-monitoring, patients can be empowered to self-manage their asthma, with aid of the asthma action plan which is given to all patients with asthma. AeviceMD can also help provide clinicians with patients' objective lung data. In the primary care setting, care is also fragmented as patients are often followed-up by a different doctor or healthcare providers. Clinicians have no objective data to track patients, and is dependent on patients' self-report and possible recall bias. There is no expected risk with the use of the device.
详细描述
The aim of the study is to evaluate the clinical outcomes, self-efficacy, quality of life, utility, and cost-effectiveness of the Aevice device for asthma self-management post exacerbation.
The objectives are to evaluate:
- The impact of Aevice on asthma symptom control (using Global Initiative for Asthma (GINA) score)
- The impact of Aevice on asthma exacerbation (measure by number of rescue therapy, dose of oral Prednisolone used, referral to emergency department, and hospitalization)
- The impact of Aevice on quality of life (using Euro Quality of Life - 5 Dimensions (E!Q5D) and mini-asthma quality of life questionnaire)
- The patients' self-efficacy using Aevice (self-developed questionnaire)
- The usability (system usability scale) and utility of Aevice (time of use and frequency of use)
- The take-up rate and demographics of participants who accept versus decline the use of Aevice
- Amount patients are willing to pay for the use of Aevice
- Clinician perception and acceptability of using technology for telemonitoring and Aevice device
- Evaluate the cost effectiveness of using Aevice
The ratio of adults to pediatrics exacerbation based on our statistics is 10:3 currently. To eliminate bias in age during randomization, stratified sampling is adopted, with a proposed mix of 126 adults and 54 pediatrics (63 adults and 27 pediatrics in each group).
Patients in each of the strata will be randomized in a 1:1 ratio to either intervention or control group according to a computer generated block randomization list. Random permuted blocks are used to ensure balance over time. The block size is determined by the study statistician and will kept confidential from the study team until final database lock. Each Patient will be assigned an individual randomization number upon randomization. This randomization number assigned will identify the patient and will be used for all documentation for this patient in this study. After the patient is screened eligibility and consented to the study, the site coordinator will call the centralized team for the randomization number and assignment. Blinding is not possible in the study team and patient as the intervention group will be receiving the new device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The outcomes assessor will not be aware of the participants' group
入排标准
- 年龄范围
- 7 Years 至 90 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma
- •Pediatric patients (age 7 to 17), adult patients (age 18 and above
- •Have an asthma exacerbation on the day of visit
- •Be willing to use the AeviceMD device
- •Has a smart phone to download the application that is paired with Aevice
- •Has wireless fidelity (WIFI) connection to use with Aevice
- •English speaking
排除标准
- •No capacity for consent
- •Concurrent chronic obstructive pulmonary disease (COPD)
结局指标
主要结局
Euro Quality of Life 5 dimensions (EQ5D)
时间窗: up to 12 weeks (baseline, week 4, week, 12)
The Euro Quality of Life 5 dimension evaluates five items related to health: 1. mobility, 2. self-care, 3. usual activities, 4. pain/discomfort, and 5. anxiety/depression. A 5-point Likert scale is used for adults, ranging from no problems, slight problems, moderate problems, severe problems, and extreme problems. Scores from the five items can be used to derive a single utility score.
Rescue therapy
时间窗: up to 12 weeks
number of times
Dose of oral Prednisolone use
时间窗: up to 12 weeks
Total dose in mg
Visit to hospital emergency department
时间窗: up to 12 weeks
number of times
Hospitalisation
时间窗: up to 12 weeks
total number of days
Asthma quality of life questionnaire (AQLQ)
时间窗: up to 12 weeks (baseline, week 4, week, 12)
The asthma quality of life questionnaire (AQLQ) will be used for participants above age 18. It consists of 32 items divided into four sections: symptoms (11 items), activity limitations (12 items), emotional function (5 items), and environmental stimuli (4 items). The intraclass correlation coefficient is 0.95. Each question is rated on a 7-point Likert scale. The Cronbach alpha is 0.9.
Pediatric asthma quality of life questionnaire (PAQLQ)
时间窗: up to 12 weeks (baseline, week 4, week, 12)
The Paediatric asthma quality of life questionnaire (PAQLQ) will be used for Paediatrics age 7 to 17. It consists of 23 items in 3 domains: activity limitation (5 items), symptoms (10 items) and emotional function (8 items). The questionnaire has been validated in Singapore, with intraclass correlation coefficient of 0.71
次要结局
- Respiratory rate(Throughout 12 weeks of study, intervention group)
- Wheeze detection trend(Throughout 12 weeks of study, intervention group)
- Duration of device usage(Throughout 12 weeks of study, intervention group)
- Usability(up to 12 weeks, intervention group)
- Payment(12 week, intervention group)
- Self-efficacy(up to 12 weeks, intervention group)
- Heart rate(Throughout 12 weeks of study, intervention group)
- Medication log(Throughout 12 weeks of study, intervention group)
研究者
Mabel Leow Qi He
Principle Investigator
SingHealth Polyclinics