E-support for Healthcare Processes - ASTHMA

NCT ID: NCT01461642

Last Updated: 2020-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2018-01-15

Brief Summary

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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

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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).

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Asthma - ICT support.

Group Type EXPERIMENTAL

Self management asthma plan indorsment.

Intervention Type OTHER

Subjects adherence to asthma self management plan will be monitored through web-based support.

Asthma, comparator - no ICT support

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Self management asthma plan indorsment.

Subjects adherence to asthma self management plan will be monitored through web-based support.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Primorska

OTHER

Sponsor Role collaborator

The University Clinic of Pulmonary and Allergic Diseases Golnik

OTHER

Sponsor Role lead

Responsible Party

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Mateja Marc Malovrh

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Clinic of Pulmonary and Allergic Disease

Golnik, , Slovenia

Site Status

Countries

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Slovenia

Other Identifiers

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L7 - 3653 - ASTHMA

Identifier Type: -

Identifier Source: org_study_id

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