- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01461642
E-support for Healthcare Processes - ASTHMA (E-ASTHMA)
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Golnik, Slovenia, 4204
- University Clinic of Pulmonary and Allergic Disease
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Asthma - ICT support.
|
Subjects adherence to asthma self management plan will be monitored through web-based support.
|
No Intervention: Asthma, comparator - no ICT support
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of exacerbations.
Time Frame: 1 year
|
Number of exacerbations per year.
|
1 year
|
Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- L7 - 3653 - ASTHMA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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