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

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
Self management asthma plan indorsment.
Sponsored by
The University Clinic of Pulmonary and Allergic Diseases Golnik
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Asthma focused on measuring Asthma, ICT Support, ACT, PEF

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University Clinic of Pulmonary and Allergic Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Asthma - ICT support.

Asthma, comparator - no ICT support

Arm Description

Outcomes

Primary Outcome Measures

Number of exacerbations.
Number of exacerbations per year.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2011
Last Updated
May 14, 2020
Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
Collaborators
University of Primorska
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1. Study Identification

Unique Protocol Identification Number
NCT01461642
Brief Title
E-support for Healthcare Processes - ASTHMA
Acronym
E-ASTHMA
Official Title
E-support for Healthcare Processes - ASTHMA
Study Type
Interventional

2. Study Status

Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
November 14, 2016 (Actual)
Study Completion Date
January 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University Clinic of Pulmonary and Allergic Diseases Golnik
Collaborators
University of Primorska

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, ICT Support, ACT, PEF

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Asthma - ICT support.
Arm Type
Experimental
Arm Title
Asthma, comparator - no ICT support
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Self management asthma plan indorsment.
Intervention Description
Subjects adherence to asthma self management plan will be monitored through web-based support.
Primary Outcome Measure Information:
Title
Number of exacerbations.
Description
Number of exacerbations per year.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
University Clinic of Pulmonary and Allergic Disease
City
Golnik
ZIP/Postal Code
4204
Country
Slovenia

12. IPD Sharing Statement

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E-support for Healthcare Processes - ASTHMA

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