protocolSection identificationModule nctId: NCT06377345, orgStudyIdInfo id: 202312-00011, briefTitle: Remote Patient Monitoring Solution for Chronic Respiratory Disease Management, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-20, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-04-22, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: SingHealth Polyclinics, class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Asthma, conditions: Asthma Attack, conditions: Asthma in Children, conditions: Asthma Acute, conditions: Asthma Chronic, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A two-group randomized controlled trial (RCT) design will be used. The control group will receive the usual care, and the intervention group will receive the Aevice device on top of usual care. Outcomes will be measured at baseline, week 4, and week 12. This is to evaluate the long-term impacts of the Aevice device. Clinicians who have interacted with participants using Aevice will also be invited to participate in an interview and clinician perception survey. A convenience sampling will be used for the recruitment of clinicians., primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The outcomes assessor will not be aware of the participants' group, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule interventions name: AeviceMD device, interventions name: Standard care, outcomesModule primaryOutcomes measure: Rescue therapy, primaryOutcomes measure: Dose of oral Prednisolone use, primaryOutcomes measure: Visit to hospital emergency department, primaryOutcomes measure: Hospitalisation, primaryOutcomes measure: Euro Quality of Life 5 dimensions (EQ5D), primaryOutcomes measure: Asthma quality of life questionnaire (AQLQ), primaryOutcomes measure: Pediatric asthma quality of life questionnaire (PAQLQ), secondaryOutcomes measure: Self-efficacy, secondaryOutcomes measure: Usability, secondaryOutcomes measure: Heart rate, secondaryOutcomes measure: Respiratory rate, secondaryOutcomes measure: Wheeze detection trend, secondaryOutcomes measure: Medication log, secondaryOutcomes measure: Duration of device usage, secondaryOutcomes measure: Payment, eligibilityModule sex: ALL, minimumAge: 7 Years, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False