RecruitingNot ApplicableNCT06377345

Remote Patient Monitoring Solution for Chronic Respiratory Disease Management


Sponsor

SingHealth Polyclinics

Enrollment

180 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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

Min Age: 7 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a wearable medical device (AeviceMD) that monitors breathing sounds to help manage asthma in children and adults, used alongside a paired smartphone app. **You may be eligible if...** - You have a diagnosis of asthma - You are between 7 and 17 years old (pediatric) or 18 or older (adult) - You are having an asthma flare-up on the day of your clinic visit - You have a smartphone and Wi-Fi access to use the paired app - You speak English **You may NOT be eligible if...** - You lack the capacity to give consent - You also have a diagnosis of COPD (chronic obstructive pulmonary disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEAeviceMD device

The 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

BEHAVIORALStandard care

All 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.


Locations(1)

SingHealth Polyclinics

Singapore, Singapore

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NCT06377345


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