E-support for Healthcare Processes - ASTHMA

Asthma Clinical Trial

— E-ASTHMA  

Official title:

E-support for Healthcare Processes - ASTHMA

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01461642
• Other study ID #: L7 - 3653 - ASTHMA
• Status: Completed
• Phase: N/A
• Start date: October 2011
• Est. completion date: January 15, 2018

Study information

• Verified date: May 2020
• Source: The University Clinic of Pulmonary and Allergic Diseases Golnik
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of the study is to establish and clinically evaluate a new approach to treating asthma by using information and communication technologies (ICT). A mobile environment, and organizational interventions to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated.

Description:

A mobile environment to improve the process of an integrated treatment of people with asthma will be identified, developed, introduced and clinically evaluated. The study will include 120 patients diagnosed with asthma that is poorly managed. The study will use the ACT (Asthma Control Test) questionnaire and an evaluation questionnaire that will cover issues regarding the satisfaction of subjects with asthma care offered. Subjects with a PEF meter, will be able to enter the value of PEF (Peak Expiratory Flow).

In addition to this, users can enter values (1) physical activity (type, duration, intensity), and (2) food (type, quantity).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 15, 2018
• Est. primary completion date: November 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• ACT points <19

• Daily symptoms> = 2 days/week

• Night symptoms> = 1 night/week

• Rescue medication > 2days/week

• At least one asthma exacerbation in the past year, but not in the last month, which was treated with oral glucocorticoid

Exclusion Criteria:

• Worsening of asthma in the last 4 weeks (treated with oral corticosteroids)

• Age >70 or <18 years

• Significant co-morbidity

• Does not own or know how to handle a mobile phone

• No internet access

• Not able to perform a PEF measurment

• Not able to use inhalor

Related Conditions & MeSH terms

• Asthma

Intervention

Other:
• Self management asthma plan indorsment.
Subjects adherence to asthma self management plan will be monitored through web-based support.

Locations

Country	Name	City	State
Slovenia	University Clinic of Pulmonary and Allergic Disease	Golnik

Sponsors (2)

Lead Sponsor	Collaborator
The University Clinic of Pulmonary and Allergic Diseases Golnik	University of Primorska

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of exacerbations.	Number of exacerbations per year.	1 year