AsthmaE-ASTHMANCT01461642
E-support for Healthcare Processes - ASTHMA
A study testing Self management asthma plan indorsment. in people with Asthma, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- Self management asthma plan indorsment.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSlovenia
- Study dates
- Oct 2011to 15 Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University Clinic of Pulmonary and Allergic Disease
Golnik, 4204
About this study
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.
Read the 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).
- Conditions
- Asthma
- Being tested
- Self management asthma plan indorsment.
- Keywords
- Asthma, ICT Support, ACT, PEF
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self management asthma plan indorsment.Other
Subjects adherence to asthma self management plan will be monitored through web-based support.
| Study group | Role | What they receive |
|---|---|---|
| Asthma - ICT support. | Experimental | Not described Receives: Other: Self management asthma plan indorsment. |
| Asthma, comparator - no ICT support | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of exacerbations.
Number of exacerbations per year.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2011 (estimated)
- Study startOct 2011
- Primary completion14 Nov 2016
- Study completion15 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases Golnik
- Sponsor type
- University, hospital or other
- Collaborators
- University of Primorska
- Responsible party
- Principal investigator, Mateja Marc Malovrh, The University Clinic of Pulmonary and Allergic Diseases Golnik
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01461642
- Sponsor's protocol ID
- L7 - 3653 - ASTHMA
- Acronym
- E-ASTHMA
- Status last verified
- May 2020
- First submitted
- 26 Oct 2011
- Last updated
- 18 May 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- E-support for Healthcare Processes - ASTHMA
- ClinicalTrials.gov ID
- NCT01461642
- Acronym / sponsor ID
- E-ASTHMA / L7 - 3653 - ASTHMA
- Conditions
- Asthma
- Keywords
- Asthma, ICT Support, ACT, PEF
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University Clinic of Pulmonary and Allergic Diseases GolnikUniversity, hospital or other
- Collaborators
- University of Primorska
- Study start
- Oct 2011
- Primary completion
- 14 Nov 2016 (actual)
- Study completion
- 15 Jan 2018 (actual)
- First posted
- 28 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Asthma - ICT support. | Experimental | Other: Self management asthma plan indorsment. |
| Asthma, comparator - no ICT support | No intervention | – |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self management asthma plan indorsment.Subjects adherence to asthma self management plan will be monitored through web-based support. | Other | Asthma - ICT support. |
Primary outcome
Number of exacerbations.
Time frame: 1 year
Number of exacerbations per year.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self management asthma plan indorsment. in people with Asthma, run by The University Clinic of Pulmonary and Allergic Diseases Golnik at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of exacerbations. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2020.