AsthmaNCT06377345
Remote Patient Monitoring Solution for Chronic Respiratory Disease Management
A study testing AeviceMD device in people with Asthma and Asthma Attack, run by SingHealth Polyclinics at 1 site in Singapore.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 90 years
- Conditions the study is for
- Asthma, Asthma Attack, Asthma in Children
- What is being tested?
- AeviceMD device
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteSingapore
- Study dates
- 1 May 2024to 30 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 90 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- No capacity for consent
- Concurrent chronic obstructive pulmonary disease (COPD)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
SingHealth Polyclinics
Singapore, 150167
Mabel QH Leow, MD, PhD, +65 6350-7598, mabel.leow.q.h@singhealth.com.sg
About this study
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.
Read more
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.
Read the 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:
- 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.
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.
- Conditions
- Asthma, Asthma Attack, Asthma in Children, Asthma Acute, Asthma Chronic
- Being tested
- AeviceMD device, Standard care
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AeviceMD deviceDevice
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
Standard careBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | 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. Receives: Behavioral: Standard care |
| Intervention group | Experimental | 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 Receives: Device: AeviceMD device; Behavioral: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rescue therapy
number of times
Measured: up to 12 weeks
Dose of oral Prednisolone use
Total dose in mg
Measured: up to 12 weeks
Visit to hospital emergency department
number of times
Measured: up to 12 weeks
Hospitalisation
total number of days
Measured: up to 12 weeks
Euro Quality of Life 5 dimensions (EQ5D)
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.
Measured: up to 12 weeks (baseline, week 4, week, 12)
Asthma quality of life questionnaire (AQLQ)
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.
Measured: up to 12 weeks (baseline, week 4, week, 12)
Pediatric asthma quality of life questionnaire (PAQLQ)
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
Measured: up to 12 weeks (baseline, week 4, week, 12)
Secondary outcomes (8)
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
Measured: up to 12 weeks, intervention group
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.
Measured: up to 12 weeks, intervention group
Heart rate
Heart rate per minute, data obtained from the device. to record the average heart rate, and frequency of being out of range.
Measured: Throughout 12 weeks of study, intervention group
Respiratory rate
respiratory rate per minute, data obtained from the device. To track average respiratory rate, and frequency of being out of range
Measured: Throughout 12 weeks of study, intervention group
Wheeze detection trend
wheeze detection, data obtained from the device. The number of wheeze per day, and number of days with wheeze will be recorded
Measured: Throughout 12 weeks of study, intervention group
Medication log
participant self entry of medication into the application, which will be obtained from the application. This will track patient frequency of taking inhaler
Measured: Throughout 12 weeks of study, intervention group
Duration of device usage
number of hours use per day on average, and number of days used
Measured: Throughout 12 weeks of study, intervention group
Payment
Amount the patient is willing to pay for the use of the device, in Singapore dollars
Measured: 12 week, intervention group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2024
- Study start1 May 2024
- Primary completion30 Sep 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SingHealth Polyclinics
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mabel Leow Qi He, SingHealth Polyclinics
- Investigators
- Mabel QH Leow, PhD, Principal investigator, SingHealth Polyclinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06377345
- Sponsor's protocol ID
- 202312-00011
- Status last verified
- May 2025
- First submitted
- 8 Apr 2024
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Patient Monitoring Solution for Chronic Respiratory Disease Management
- ClinicalTrials.gov ID
- NCT06377345
- Acronym / sponsor ID
- 202312-00011
- Conditions
- Asthma, Asthma Attack, Asthma in Children, Asthma Acute, Asthma Chronic
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- SingHealth PolyclinicsUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Sep 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 22 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Behavioral: Standard careThe 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 group | Experimental | Device: AeviceMD device, Behavioral: Standard careThe 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 |
Who may qualify
- Ages
- 7 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (2 listed)
- No capacity for consent
- Concurrent chronic obstructive pulmonary disease (COPD)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AeviceMD 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 | Device | Intervention group |
| Standard careAll 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. | Behavioural | Control group, Intervention group |
Primary outcome
Rescue therapy
Time frame: up to 12 weeks
number of times
Dose of oral Prednisolone use
Time frame: up to 12 weeks
Total dose in mg
Visit to hospital emergency department
Time frame: up to 12 weeks
number of times
Hospitalisation
Time frame: up to 12 weeks
total number of days
Euro Quality of Life 5 dimensions (EQ5D)
Time frame: 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.
Asthma quality of life questionnaire (AQLQ)
Time frame: 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)
Time frame: 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
8 secondary outcomes
Self-efficacy
Time frame: up to 12 weeks, intervention group
Usability
Time frame: up to 12 weeks, intervention group
Heart rate
Time frame: Throughout 12 weeks of study, intervention group
Respiratory rate
Time frame: Throughout 12 weeks of study, intervention group
Wheeze detection trend
Time frame: Throughout 12 weeks of study, intervention group
Medication log
Time frame: Throughout 12 weeks of study, intervention group
Duration of device usage
Time frame: Throughout 12 weeks of study, intervention group
Payment
Time frame: 12 week, intervention group
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mabel QH Leow, PhD principal investigator
SingHealth Polyclinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AeviceMD device in people with Asthma and Asthma Attack, run by SingHealth Polyclinics at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mabel QH Leow, PhD (+65 63507598, mabel.leow.q.h@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rescue therapy (time frame: up to 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.