Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma): Adult

BRONCHIAL ASTHMA Clinical Trial

Official title:

Self-Management Using Smartphone Application for Chronic Disease Care in Real siTuation (SMART-Asthma) in Adult

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01918293
• Other study ID #: SMART-ASTHMA (ADULT)
• Status: Completed
• Phase: N/A
• First received: August 6, 2013
• Last updated: November 26, 2013
• Start date: September 2012
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Inje University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Bronchial asthma is an chronic airway disease with bronchial hypersensitivity due to inflammation and bronchial muscle contraction. It can cause recurrent dyspnea, cough, wheezing and severe life-threatening attack and lower quality of life. In addition, it make large amount of socioeconomic loss as about 3.7 billion US dollars.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• using smartphone

• alleged bronchial asthma over 3months & positive of bronchodilator response test or bronchial provocation test

Exclusion Criteria:

• COPD

• active pulmonary TUBERCULOSIS

• Acute exacerbation within 4weeks

• severe psychological disorder

• severe systemic disease; severe LC, ESRD ...

• MALIGNANCY

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma
• BRONCHIAL ASTHMA
• Chronic Disease

Intervention

Device:
• SMART ARM
The smartphone application for self-management of Asthma offers symptom diary, general information for asthma, the information of asthma drugs,the guideline for inhaler and the specific action plan according to daily symptom and FEV1.

Locations

Country	Name	City	State
Korea, Republic of	Haeundae Paik Hospital	Busan

Sponsors (1)

Lead Sponsor	Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The efficacy of smartphone application for asthma control test (ACT)and quality of life	Using ACT and ALQL score (QoL), we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group	at least 2 times a week	No
Secondary	FEV1 (Forced expiratory volume in 1 second ) and FVC (Forced vital capacity)	Using spirometer to check the variation of FEV1,we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group	at least 1 time a month	No
Secondary	Acute exacerbation of bronchial asthma	Using medical record and questionaire of acute exacerbation,we will investigate the efficacy of smanrtphone application for control of asthma compared to smartphone app. using group and smartphone app. non-using group	at least 1 time a week	No