Clinical trial NCT04808089: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2021-03-19
Enrollment: 48
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized control trial
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Asthma control
timeFrame: 3 months
Secondary outcomes:
measure: The compliance of controller
timeFrame: 3 months
measure: The satisfaction of digital tools in study group
timeFrame: 3 months
Other outcomes:
measure: The impact of digital tools on clinical practice
timeFrame: 3 month
Locations:
city: Taoyuan
country: Taiwan
facility: Department of Thoracic Medicine, Chang Gung Memorial Hospital
Study officials:
affiliation: Chang Gung Memorial Hospital
name: Ting-Yu Lin, M.D.
role: PRINCIPAL_INVESTIGATOR
References: