AsthmaINCASNCT02425293
INCAS - Integrated Care of Asthma in Switzerland
A study testing asthma patient education in people with Asthma, run by Cantonal Hospital, Baselland.
Trial summary
The aim of this study was to investigate the effect of standardized patient education on asthma control. In collaboration with two health insurance companies, pharmacists and pneumologists, patients with asthma were recruited. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Asthma
- What is being tested?
- asthma patient education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 223 participants
- Where
- No sites listed yet
- Study dates
- Jun 2012to Dec 2014
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- patients with clinical asthma diagnosis
- written informed consent
Who cannot join
- inadequate knowledge of the German language
- subjects with severe diseases with life expectancy under one year
- subjects with known Chronic Obstructive Pulmonary Disease (COPD)
About this study
The aim of this study was to investigate the effect of standardized patient education on asthma control. In collaboration with two health insurance companies, pharmacists and pneumologists, patients with asthma were recruited. They completed the "Asthma Control Test (ACT)" and the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire to assess asthma control and patients' satisfaction with the health care service they received. Additionally, patients were offered the possibility to participate in a patient education seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year, patients were asked to complete the questionnaires again. Comparisons of intraindividual changes and differences regarding ACT and PACIC 5A between patients with and without patient education were made.
- Conditions
- Asthma
- Being tested
- asthma patient education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asthma patient educationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Patients participating in a patient education seminar Receives: Behavioral: asthma patient education |
| Control | No intervention | Patients not participating in a patient education seminar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of patient characteristics between the intervention and the control group
Measured: baseline
Comparison of asthma control between the intervention and the control group
Asthma control is measured using the Asthma Control Test (ACT).
Measured: baseline
Comparison of patient satisfaction between the intervention and the control group
Patient satisfaction is measured using the Patient Assessment of Chronic Illness Care (PACIC 5A) questionnaire.
Measured: baseline
Secondary outcomes (4)
Comparison of asthma control at baseline and after one year in the intervention group.
Analysis of change in asthma control (using the Asthma Control Test (ACT)) in the intervention group from baseline to follow up (after one year).
Measured: baseline and follow up (after one year)
Comparison of asthma control at baseline and after one year in the control group.
Analysis of change in asthma control (using the Asthma Control Test (ACT)) in the control group from baseline to follow up (after one year).
Measured: baseline and follow up (after one year)
Comparison of patient satisfaction at baseline and after one year in the intervention group.
Analysis of change in patient satisfaction (using the PACIC 5A questionnaire) in the intervention group from baseline to follow up (after one year).
Measured: baseline and follow up (after one year)
Comparison of patient satisfaction at baseline and after one year in the control group.
Analysis of change in patient satisfaction (using the PACIC 5A questionnaire) in the control group from baseline to follow up (after one year).
Measured: baseline and follow up (after one year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startJun 2012
- Primary completionDec 2014
- Study completionDec 2014
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
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Baselland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Jörg Leuppi, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02425293
- Sponsor's protocol ID
- 274/11
- Acronym
- INCAS
- Status last verified
- Apr 2015
- First submitted
- 10 Apr 2015
- Last updated
- 23 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INCAS - Integrated Care of Asthma in Switzerland
- ClinicalTrials.gov ID
- NCT02425293
- Acronym / sponsor ID
- INCAS / 274/11
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- Cantonal Hospital, BasellandUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 23 Apr 2015 (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 aim of this study was to investigate the effect of standardized patient education on asthma control. In collaboration with two health insurance companies, pharmacists and pneumologists, patients with asthma were recruited. They completed the "Asthma Control Test (ACT)" and the "Patient Assessment of Chronic Illness Care (PACIC 5A)" questionnaire to assess asthma control and patients' satisfaction with the health care service they received. Additionally, patients were offered the possibility to participate in a patient education seminar run by the Swiss lung leagues or the Swiss allergy centre (aha!). After one year, patients were asked to complete the questionnaires again. Comparisons of intraindividual changes and differences regarding ACT and PACIC 5A between patients with and without patient education were made.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: asthma patient educationPatients participating in a patient education seminar |
| Control | No intervention | –Patients not participating in a patient education seminar |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- patients with clinical asthma diagnosis
- written informed consent
Key exclusion criteria (3 listed)
- inadequate knowledge of the German language
- subjects with severe diseases with life expectancy under one year
- subjects with known Chronic Obstructive Pulmonary Disease (COPD)
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 |
|---|---|---|
| asthma patient education | Behavioural | Intervention |
Primary outcome
Comparison of patient characteristics between the intervention and the control group
Time frame: baseline
Comparison of asthma control between the intervention and the control group
Time frame: baseline
Asthma control is measured using the Asthma Control Test (ACT).
Comparison of patient satisfaction between the intervention and the control group
Time frame: baseline
Patient satisfaction is measured using the Patient Assessment of Chronic Illness Care (PACIC 5A) questionnaire.
4 secondary outcomes
Comparison of asthma control at baseline and after one year in the intervention group.
Time frame: baseline and follow up (after one year)
Comparison of asthma control at baseline and after one year in the control group.
Time frame: baseline and follow up (after one year)
Comparison of patient satisfaction at baseline and after one year in the intervention group.
Time frame: baseline and follow up (after one year)
Comparison of patient satisfaction at baseline and after one year in the control group.
Time frame: baseline and follow up (after one 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 23 Apr 2015.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing asthma patient education in people with Asthma, run by Cantonal Hospital, Baselland.
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 2 inclusion and 3 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 23 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
Comparison of patient characteristics between the intervention and the control group (time frame: baseline). The study lists 3 primary outcomes in all. 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 23 Apr 2015.