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E-support for Healthcare Processes - ASTHMA (E-ASTHMA)

This study is currently recruiting participants.
Verified October 2011 by The University Clinic of Pulmonary and Allergic Diseases Golnik
Sponsor:
Collaborator:
University of Primorska
Information provided by (Responsible Party):
Stanislav Šuškovič, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier:
NCT01461642
First received: October 26, 2011
Last updated: October 27, 2011
Last verified: October 2011
History of Changes

October 26, 2011
October 27, 2011
October 2011
December 2012   (final data collection date for primary outcome measure)
Number of exacerbations. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Number of exacerbations per year.
Same as current
Complete list of historical versions of study NCT01461642 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
E-support for Healthcare Processes - ASTHMA
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.

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).
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Asthma
Other: Self management asthma plan indorsment.
Subjects adherence to asthma self management plan will be monitored through web-based support.
  • Experimental: Asthma - ICT support.
    Intervention: Other: Self management asthma plan indorsment.
  • No Intervention: Asthma, comparator - no ICT support
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
April 2013
December 2012   (final data collection date for primary outcome measure)

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
Both
18 Years to 70 Years
No
Contact: Stanislav Šuškovič, MD, PhD, Prof. +386 4 2569 390 stanislav.suskovic@klinika-golnik.si
Contact: Iztok Cukjati +386 40 186 268 iztok.cukjati@upr.si
Slovenia
 
NCT01461642
L7 - 3653 - ASTHMA
No
Stanislav Šuškovič, The University Clinic of Pulmonary and Allergic Diseases Golnik
The University Clinic of Pulmonary and Allergic Diseases Golnik
University of Primorska
Not Provided
The University Clinic of Pulmonary and Allergic Diseases Golnik
October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP