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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04808089
• Other study ID #: 202100251B0
• Status: Recruiting
• Phase: N/A
• Start date: April 2, 2021
• Est. completion date: July 31, 2022

Study information

• Verified date: March 2021
• Source: Chang Gung Memorial Hospital
• Contact: Ting-Yu Lin
• Phone: 886-3-3281200
• Email: yuebaoyuebao[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: July 31, 2022
• Est. primary completion date: July 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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".
• 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.

Locations

Country	Name	City	State
Taiwan	Department of Thoracic Medicine, Chang Gung Memorial Hospital	Taoyuan

Sponsors (1)

Lead Sponsor	Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The impact of digital tools on clinical practice	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
Primary	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.	3 months
Secondary	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	3 months
Secondary	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	3 months