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OpenTrials
Completed

NCT Number: NCT01461642

E-support for Healthcare Processes - ASTHMA

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Clinic of Pulmonary and Allergic Disease

Golnik, 4204, Slovenia

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Self management asthma plan indorsment.

Other

Subjects adherence to asthma self management plan will be monitored through web-based support.

Primary outcomes

  1. Number of exacerbations.

    Time frame: 1 year

    Number of exacerbations per year.

Sponsors and collaborators

Lead sponsor

The University Clinic of Pulmonary and Allergic Diseases Golnik

Other

Collaborators

  • University of Primorska

Registry information

Acronym: E-ASTHMA

Important dates

Study start
2011
Primary completion
2016
Study completion
2018
First posted
Oct 28, 2011
Registry last updated
May 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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