INCAS - Integrated Care of Asthma in Switzerland

Asthma Clinical Trial

— INCAS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02425293
• Other study ID #: 274/11
• Status: Completed
• Phase: N/A
• First received: April 10, 2015
• Last updated: April 20, 2015
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: April 2015
• Source: Cantonal Hosptal, Baselland
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 223
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• asthma patient education

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cantonal Hosptal, Baselland

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of patient characteristics between the intervention and the control group		baseline	No
Primary	Comparison of asthma control between the intervention and the control group	Asthma control is measured using the Asthma Control Test (ACT).	baseline	No
Primary	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.	baseline	No
Secondary	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).	baseline and follow up (after one year)	No
Secondary	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).	baseline and follow up (after one year)	No
Secondary	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).	baseline and follow up (after one year)	No
Secondary	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).	baseline and follow up (after one year)	No