About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
No capacity for consent
Concurrent chronic obstructive pulmonary disease (COPD)
Trial design
Parallel
Treatments tested in this trial
AeviceMD device
DeviceThe intervention group will receive the AeviceMD device on top of standard care provided by the Polyclinic. They will use the AeviceMD device for 12 weeks. They are expected to use the device for at least 5 hours at night when they are asleep. However, they can also use the device at any time of the time, based on their own preference. The AeviceMD device will provide patients with objective information of their breathing (respiratory rate) and lung sounds. This objective information can be used for participants to self-manage their asthma following the asthma action plan. During the clinical follow-up, participants can show the clinician their lung parameters, to improve clinical management
Standard care
BehavioralAll participants will receive the standard care provided by the Polyclinic. This can include a telephone follow-up by a nurse within 5 days, and follow-ups with a doctor after one week. All patients with asthma should also have an asthma action plan which provides them instructions on how to manage their asthma and the medications required when they experience symptoms. These symptoms include wheezing, chest tightness, difficulty breathing, coughing, night-waking, and symptom interfering with day-to-day activities.
Treatment groups
Trial outcomes
Primary outcomes
Rescue therapy
number of times
Dose of oral Prednisolone use
Total dose in mg
Visit to hospital emergency department
number of times
Hospitalisation
total number of days
Secondary outcomes
Self-efficacy
Self-efficacy will be measured using a self-developed questionnaire consisting of 6 questions. Each question will be rated on a 5-point Likert scale (strongly agree to strongly disagree). This is to evaluate if Aevice was useful for self-management of asthma
Usability
The usability of device will be measured using the system usability scale (SUS). The scale consists of 10 items, rated on a 5-point Likert scale (score 1 to 5), with scores ranging from 10 to 50. Higher scores represent higher usability.
Heart rate
Heart rate per minute, data obtained from the device. to record the average heart rate, and frequency of being out of range.
Respiratory rate
respiratory rate per minute, data obtained from the device. To track average respiratory rate, and frequency of being out of range
Sponsors and contacts
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