NCT01461642

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2011

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 28, 2011

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 14, 2016

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2018

Completed
Last Updated

May 18, 2020

Status Verified

May 1, 2020

Enrollment Period

5.1 years

First QC Date

October 26, 2011

Last Update Submit

May 14, 2020

Conditions

Asthma

Keywords

AsthmaICT SupportACTPEF

Outcome Measures

Primary Outcomes (1)

  • Number of exacerbations.

    Number of exacerbations per year.

    1 year

Study Arms (2)

Asthma - ICT support.

EXPERIMENTAL
Other: Self management asthma plan indorsment.

Asthma, comparator - no ICT support

NO INTERVENTION

Interventions

Self management asthma plan indorsment.OTHER

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

Asthma - ICT support.

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Clinic of Pulmonary and Allergic Disease

Golnik, 4204, Slovenia

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

October 26, 2011

First Posted

October 28, 2011

Study Start

October 1, 2011

Primary Completion

November 14, 2016

Study Completion

January 15, 2018

Last Updated

May 18, 2020

Record last verified: 2020-05

Locations

SL(1)