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Clinical Trials/NCT01461642
NCT01461642
Completed
Not Applicable

E-support for Healthcare Processes - ASTHMA

The University Clinic of Pulmonary and Allergic Diseases Golnik1 site in 1 country100 target enrollmentOctober 2011
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
Enrollment
100
Locations
1
Primary Endpoint
Number of exacerbations.
Status
Completed
Last Updated
5 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
October 2011
End Date
January 15, 2018
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
Responsible Party
Principal Investigator
Principal Investigator

Mateja Marc Malovrh

MD, PhD

The University Clinic of Pulmonary and Allergic Diseases Golnik

Eligibility Criteria

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

Outcomes

Primary Outcomes

Number of exacerbations.

Time Frame: 1 year

Number of exacerbations per year.

Study Sites (1)

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