Remote Patient Monitoring Solution for Chronic Respiratory Disease Management

NCT06377345 | Recruiting

• 1 other identifier: 202312-00011
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Asthma Attack; Asthma in Children; Asthma Acute; Asthma Chronic

Outcome Measures

Primary Outcomes (7)

• Rescue therapy

  number of times

  up to 12 weeks

• Dose of oral Prednisolone use

  Total dose in mg

  up to 12 weeks

• Visit to hospital emergency department

  number of times

  up to 12 weeks

• Hospitalisation

  total number of days

  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.

  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.

  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

  up to 12 weeks (baseline, week 4, week, 12)

Secondary Outcomes (8)

• Self-efficacy

  up to 12 weeks, intervention group

• Usability

  up to 12 weeks, intervention group

• Heart rate

  Throughout 12 weeks of study, intervention group

• Respiratory rate

  Throughout 12 weeks of study, intervention group

• Wheeze detection trend

  Throughout 12 weeks of study, intervention group

Study Arms (2)

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.

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

Device: AeviceMD device; Behavioral: Standard care

Interventions

AeviceMD device 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

Intervention group

Standard care BEHAVIORAL

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.

Control group; Intervention group

Eligibility Criteria

• Age: 7 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• SingHealth Polyclinics: lead

Study Sites (1)

SingHealth Polyclinics

Singapore, 150167, Singapore

RECRUITING

MeSH Terms

Conditions

Asthma

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Mabel QH Leow, PhD

  SingHealth Polyclinics

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mabel QH Leow, PhD

CONTACT

+65 63507598; mabel.leow.q.h@singhealth.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcomes assessor will not be aware of the participants' group
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 22, 2024
• Study Start: May 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 15, 2025

Record last verified: 2025-05

Locations

SG (1)