The Feasibility of Asthma Application of Mobile Phone and Mobile Spirometry for Home Monitor of Asthma Patients

July 28, 2021 updated by: Ting-Yu Lin, Chang Gung Memorial Hospital

The Feasibility of Asthma Application of Mobile Phone and Mobile Spirometry for Home Monitor of Asthma Patients to Achieve Optimal Asthma Control

The aim of the present study is to explore if the "Health Lung" application of smart phone and portable spirometry "ezOxygen" can further improve asthma control for chronic asthma adult patients with well asthma control (ACT 20~24, but not 25), compared to hospital-based usual care in a medical center.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Asthma is a chronic inflammatory disease. Despite we have academic treatment guidelines, and the asthma treatment develops persistently, many asthma patients do not have well control.

Asthma Control Test (ACT) is a patient self-administered tool for identifying those with poorly controlled asthma. ACT includes 5 items on 5-point scale, with 4-week recall on symptoms and daily functioning. The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.

In addition to correct diagnosis and prescription by physicians, achieving asthma well control depend on the patient's ability of self- management.

The self-management of asthma patients includes monitor of symptoms, monitor of peak expiratory flow, compliance of inhaler and avoiding the asthma triggers.

Portable digital tools may be the possible solution for home monitor of asthma patients. Through the application of mobile phone and hand-held mobile spirometry, asthma patients can monitor their symptoms and lung function at home outside of hospital.(5-7)。

"Health Lung" (AstraZeneca Pharmaceuticals LP) is the application for mobile phone to help asthma care and is available freely in Google Play. Health Lung can be connected to the mobile spirometry, "ezOxygen" (Genius Holding Co.,Ltd Taiwan Branch).

Therefore, the functions of this App. include asthma control monitor, lung function monitor, controller and reliver inhaler reminder and recording, asthma educational topics in brief and information of air quality. The physicians can get the information about control status, lung function, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung".

However, how the patients are willing to use digital tools at home and what is the real impact on the current hospital-based asthma care need to be validated.

The aim of the present study is to explore if the "Health Lung" application of smart phone and portable spirometry "ezOxygen" can further improve asthma control for chronic asthma adult patients with well asthma control (ACT 20~24, but not 25), compared to hospital-based usual care in a medical center.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taoyuan, Taiwan, 33305
        • Recruiting
        • Department of Thoracic Medicine, Chang Gung Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients aged 20 to 65 years old.
  • Regular prescription of inhaled corticosteroid-containing medications at least 6 months.
  • The asthma control is well but not in total control: ACT 20~24, but not to full score 25.

Exclusion Criteria:

  • Patients were excluded if they do not have internet-connecting smart phone.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Health Lung App. +ezOxygen

Health Lung" App. (AstraZeneca Pharmaceuticals LP) is the application for mobile phone to help asthma care and is available freely in Google Play. Health Lung can be connected to the mobile spirometry, "ezOxygen" (Genius Holding Co.,Ltd Taiwan Branch).

The functions of Health Lung App. include asthma control monitor, lung function monitor, controller and reliver inhaler reminder and recording, asthma educational topics in brief and information of air quality

Subjects can get reminder to use inhaler on schedule, input ACT score to evaluate the asthma control, get education materials about asthma and operate spirometer to access lung function outside of hospital.

he physicians in charge will get the information about control status score by ACT, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung".
Other: Health Lung App. of mobile phone+ezOxygen mobile spirometry

Subjects can get reminder to use inhaler on schedule, input ACT score to evaluate the asthma control, get education materials about asthma and operate spirometer to access lung function outside of hospital.

The physicians can get the information about control status, lung function, adherence of controller and usage of reliver of patients between each clinical visit, if patients following the instruction of "Health Lung".
Active Comparator: Usual care
The research assistant assess/ teach inhaler technique, offering the asthma education as the regular clinical service.
Other: Usual care
The research assistant assess/ teach inhaler technique, offering advice on adherence, delivering patient self-management asthma action plan and education the meaning of asthma control accessed by ACT.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Asthma control
Time Frame: 3 months
The improvement of asthma control evaluated by Asthma Control Test (ACT). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.
3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The compliance of controller
Time Frame: 3 months

The adherence of asthma inhaler drugs will be evaluated by the questionnaire about inhaler compliance.

According to your memory, how often did you forget to follow the doctor's order to use the inhaler(s) in the past 4 weeks?

1.Almost every day; 2. No more than 7 days; 3. No more than 14 days; 4. More than 15 days
3 months
The satisfaction of digital tools in study group
Time Frame: 3 months
The subjects in study arm will be asked about how they satisfy the functions of "Health lung" App. and ezOxygen spirometry via 100-mm length visual analogue scale. 0: the most dissatisfaction/unhelpful to 100 mm: the most satisfaction/helpful
3 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The impact of digital tools on clinical practice
Time Frame: 3 month
The physicians in charge in study arm will be ask if they order any further exam or prescription due to the information provided by digital tools.
3 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Gung Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Ting-Yu Lin, M.D., Chang Gung Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 2, 2021

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2022

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 19, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 30, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 28, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202100251B0

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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