- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02425293
INCAS - Integrated Care of Asthma in Switzerland (INCAS)
April 20, 2015 updated by: Prof. Dr. Jörg Leuppi, Cantonal Hosptal, Baselland
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 Overview
Study Type
Interventional
Enrollment (Actual)
223
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients with clinical asthma diagnosis
- written informed consent
Exclusion Criteria:
- inadequate knowledge of the German language
- subjects with severe diseases with life expectancy under one year
- subjects with known Chronic Obstructive Pulmonary Disease (COPD)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
Patients participating in a patient education seminar
|
|
|
No Intervention: Control
Patients not participating in a patient education seminar
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of patient characteristics between the intervention and the control group
Time Frame: baseline
|
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).
|
baseline
|
|
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.
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Comparison of asthma control at baseline and after one year in the intervention group.
Time Frame: baseline and follow up (after one year)
|
Analysis of change in asthma control (using the Asthma Control Test (ACT)) in the intervention group from baseline to follow up (after one year).
|
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)
|
Analysis of change in asthma control (using the Asthma Control Test (ACT)) in the control group from baseline to follow up (after one year).
|
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)
|
Analysis of change in patient satisfaction (using the PACIC 5A questionnaire) in the intervention group from baseline to follow up (after one year).
|
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)
|
Analysis of change in patient satisfaction (using the PACIC 5A questionnaire) in the control group from baseline to follow up (after one year).
|
baseline and follow up (after one year)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2012
Primary Completion (Actual)
December 1, 2014
Study Completion (Actual)
December 1, 2014
Study Registration Dates
First Submitted
April 10, 2015
First Submitted That Met QC Criteria
April 20, 2015
First Posted (Estimate)
April 23, 2015
Study Record Updates
Last Update Posted (Estimate)
April 23, 2015
Last Update Submitted That Met QC Criteria
April 20, 2015
Last Verified
April 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 274/11
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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