E-support for Healthcare Processes - ASTHMA

Not Applicable

Completed

• Conditions: Asthma
• Interventions: Other: Self management asthma plan indorsment.

• Registration Number: NCT01461642
• Lead Sponsor: The University Clinic of Pulmonary and Allergic Diseases Golnik

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-26
• Study First Submitted QC: 2011-10-27
• Study First Posted: 2011-10-28
• Primary Completion: 2016-11-14
• Study Completion: 2018-01-15
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-14
• Last Update Posted: 2020-05-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Asthma - ICT support.	Self management asthma plan indorsment.	-

Primary Outcome Measures

Name	Time	Method
Number of exacerbations.	1 year	Number of exacerbations per year.

Trial Locations

Locations (1)

University Clinic of Pulmonary and Allergic Disease; 🇸🇮 Golnik, Slovenia