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

Primary Purpose

Asthma

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Health Lung App. of mobile phone+ezOxygen mobile spirometry
Usual care
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Asthma

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Thoracic Medicine, Chang Gung Memorial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Health Lung App. +ezOxygen

Usual care

Arm Description

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".

The research assistant assess/ teach inhaler technique, offering the asthma education as the regular clinical service.

Outcomes

Primary Outcome Measures

Asthma control
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.

Secondary Outcome Measures

The compliance of controller
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
The satisfaction of digital tools in study group
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

Full Information

First Posted
March 18, 2021
Last Updated
July 28, 2021
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04808089
Brief Title
The Feasibility of Asthma Application of Mobile Phone and Mobile Spirometry for Home Monitor of Asthma Patients
Official Title
The Feasibility of Asthma Application of Mobile Phone and Mobile Spirometry for Home Monitor of Asthma Patients to Achieve Optimal Asthma Control
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 2, 2021 (Actual)
Primary Completion Date
July 1, 2022 (Anticipated)
Study Completion Date
July 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective randomized control trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Health Lung App. +ezOxygen
Arm Type
Experimental
Arm Description
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".
Arm Title
Usual care
Arm Type
Active Comparator
Arm Description
The research assistant assess/ teach inhaler technique, offering the asthma education as the regular clinical service.
Intervention Type
Other
Intervention Name(s)
Health Lung App. of mobile phone+ezOxygen mobile spirometry
Intervention Description
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".
Intervention Type
Other
Intervention Name(s)
Usual care
Intervention Description
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.
Primary Outcome Measure Information:
Title
Asthma control
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
The compliance of controller
Description
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
Time Frame
3 months
Title
The satisfaction of digital tools in study group
Description
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
Time Frame
3 months
Other Pre-specified Outcome Measures:
Title
The impact of digital tools on clinical practice
Description
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.
Time Frame
3 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting-Yu Lin
Phone
886-3-3281200
Ext
8468
Email
yuebaoyuebao@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ting-Yu Lin, M.D.
Organizational Affiliation
Chang Gung Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Thoracic Medicine, Chang Gung Memorial Hospital
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ting-Yu Lin, MD
Phone
886-3-3281200
Ext
8157
Email
yuebaoyuebao@yahoo.com.tw
First Name & Middle Initial & Last Name & Degree
Ting-Yu Lin, MD

12. IPD Sharing Statement

Learn more about this trial

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

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