Clinical trial NCT06377345: Remote Patient Monitoring Solution for Chronic Respiratory Disease Management
Official title: Remote Patient Monitoring Solution for Chronic Respiratory Disease Management
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma
Asthma Attack
Asthma in Children
Asthma Acute
Asthma Chronic
Lead sponsor: SingHealth Polyclinics
Sponsor class: OTHER
First posted: 2024-04-22
Enrollment: 180
Sex: ALL
Minimum age (years): 7
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

Brief 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.

Detailed description: 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:

1. The impact of Aevice on asthma symptom control (using Global Initiative for Asthma (GINA) score)
2. The impact of Aevice on asthma exacerbation (measure by number of rescue therapy, dose of oral Prednisolone used, referral to emergency department, and hospitalization)
3. The impact of Aevice on quality of life (using Euro Quality of Life - 5 Dimensions (E!Q5D) and mini-asthma quality of life questionnaire)
4. The patients' self-efficacy using Aevice (self-developed questionnaire)
5. The usability (system usability scale) and utility of Aevice (time of use and frequency of use)
6. The take-up rate and demographics of participants who accept versus decline the use of Aevice
7. Amount patients are willing to pay for the use of Aevice
8. Clinician perception and acceptability of using technology for telemonitoring and Aevice device
9. 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.

Control group

The control group 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.

Intervention

The intervention group will receive the Aevice device on top of standard care provided by the Polyclinic. They will use the Aevice 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 Aevice 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 the their lung data from the Aevice application on their phone, for the clinician

The research coordinator will provide the participants with the Aevice device, and download the application on the participants' phone. The participant will be able to observe their trend on the application's dashboard They will be informed to share their lung parameters with their nurse during the follow-up call, and show the doctor data on their lung sounds during the follow-up visit. Participants will return the device at the end of the study period.

The participants will be instructed to contact the research coordinator if they face difficulties using the device. This will include problems with the Aevice device and phone application, or participants' do not know how to use the application.

Recruitment

Rescue therapy is administered by the nurses. The nurses in the Polyclinics will help identify patients in the treatment room who meet the inclusion criteria, and invite them to participate in the study. If the patient is agreeable, the nurse will refer the potential participant to the research coordinator. The doctors who are attending to patients with asthma exacerbation can also refer the patient to the research coordinator. The research coordinator will provide the participant information sheet (PIS), explain the details of the study, and go through the consent process with the participant. If the potential participant agrees to participate in the study, written informed consent will be obtained. After obtaining the informed consent, the research coordinator will collect the baseline data from the participant, allocate them to the group, and provide participants in the intervention group with the device.

The clinicians will be invited by email to participate in the survey and qualitative interview study, with a participant information sheet to understand the study rationale. If they agree to participate, the survey will be sent to them. They can participate in the survey only, and not the qualitative interview.

This study will be conducted at SingHealth Polyclinics.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* No capacity for consent
* Concurrent chronic obstructive pulmonary disease (COPD)

Primary outcomes:
measure: Rescue therapy
timeFrame: up to 12 weeks
measure: Dose of oral Prednisolone use
timeFrame: up to 12 weeks
measure: Visit to hospital emergency department
timeFrame: up to 12 weeks
measure: Hospitalisation
timeFrame: up to 12 weeks
measure: Euro Quality of Life 5 dimensions (EQ5D)
timeFrame: up to 12 weeks (baseline, week 4, week, 12)
measure: Asthma quality of life questionnaire (AQLQ)
timeFrame: up to 12 weeks (baseline, week 4, week, 12)
measure: Pediatric asthma quality of life questionnaire (PAQLQ)
timeFrame: up to 12 weeks (baseline, week 4, week, 12)
Secondary outcomes:
measure: Self-efficacy
timeFrame: up to 12 weeks, intervention group
measure: Usability
timeFrame: up to 12 weeks, intervention group
measure: Heart rate
timeFrame: Throughout 12 weeks of study, intervention group
measure: Respiratory rate
timeFrame: Throughout 12 weeks of study, intervention group
measure: Wheeze detection trend
timeFrame: Throughout 12 weeks of study, intervention group
measure: Medication log
timeFrame: Throughout 12 weeks of study, intervention group
measure: Duration of device usage
timeFrame: Throughout 12 weeks of study, intervention group
measure: Payment
timeFrame: 12 week, intervention group
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: SingHealth Polyclinics
Study officials:
affiliation: SingHealth Polyclinics
name: Mabel QH Leow, PhD
role: PRINCIPAL_INVESTIGATOR
References: