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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
  Purpose

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.


Condition Intervention
Asthma
 Other: Self management asthma plan indorsment.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: E-support for Healthcare Processes - ASTHMA

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by The University Clinic of Pulmonary and Allergic Diseases Golnik:

Primary Outcome Measures:
  • Number of exacerbations. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of exacerbations per year.


Estimated Enrollment: 120
Study Start Date: October 2011
Estimated Study Completion Date: April 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Asthma - ICT support. Other: Self management asthma plan indorsment.
Subjects adherence to asthma self management plan will be monitored through web-based support.
No Intervention: Asthma, comparator - no ICT support

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).

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01461642

Contacts
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

Locations
Slovenia
University Clinic of Pulmonary and Allergic Disease Recruiting
Golnik, Slovenia, 4204
Contact: Stanislav Šuškovič, MD, PhD, Prof.     +386 4 2569 390     stanislav.suskovic@klinika-golnik.si    
Contact: Jana Bogataj     +386 4 2569 500     jana.bogataj@klinika-golnik.si    
Sub-Investigator: Sabina Škrgat Kristan, MD, PhD            
Sub-Investigator: Mateja Marc Malovrh, MD, PhD            
Sub-Investigator: Matjaž Fležar, MD PhD Doc            
Sub-Investigator: Mihaela Zidarn, MD, MSci            
Sponsors and Collaborators
The University Clinic of Pulmonary and Allergic Diseases Golnik
University of Primorska
  More Information

No publications provided

Responsible Party: Stanislav Šuškovič, Prof., MD, PhD, The University Clinic of Pulmonary and Allergic Diseases Golnik
ClinicalTrials.gov Identifier: NCT01461642     History of Changes
Other Study ID Numbers: L7 - 3653 - ASTHMA
Study First Received: October 26, 2011
Last Updated: October 27, 2011
Health Authority: Slovenia: Agency for Medicinal Products - Ministry of Health

Keywords provided by The University Clinic of Pulmonary and Allergic Diseases Golnik:
Asthma
ICT Support
ACT
PEF

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on June 18, 2013