NCT04808089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
48

participants targeted

Target at P25-P50 for not_applicable asthma

Timeline
Completed

Started Apr 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 18, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2021

Completed
14 days until next milestone

Study Start

First participant enrolled

April 2, 2021

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2022

Completed
Last Updated

July 30, 2021

Status Verified

March 1, 2021

Enrollment Period

1.2 years

First QC Date

March 18, 2021

Last Update Submit

July 28, 2021

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • The compliance of controller

    3 months

  • The satisfaction of digital tools in study group

    3 months

Other Outcomes (1)

  • The impact of digital tools on clinical practice

    3 month

Study Arms (2)

Health Lung App. +ezOxygen

EXPERIMENTAL

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

Usual care

ACTIVE COMPARATOR

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

Other: Usual care

Interventions

Health Lung App. of mobile phone+ezOxygen mobile spirometryOTHER

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".

Health Lung App. +ezOxygen
Usual careOTHER

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.

Usual care

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Thoracic Medicine, Chang Gung Memorial Hospital

Taoyuan District, 33305, Taiwan

RECRUITING

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Ting-Yu Lin, M.D.

    Chang Gung Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ting-Yu Lin

CONTACT

886-3-3281200yuebaoyuebao@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Prospective randomized control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

March 18, 2021

First Posted

March 19, 2021

Study Start

April 2, 2021

Primary Completion

July 1, 2022

Study Completion

July 31, 2022

Last Updated

July 30, 2021

Record last verified: 2021-03

Locations

TW(1)