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INCAS - Integrated Care of Asthma in Switzerland (INCAS)

Primary Purpose

Asthma

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
asthma patient education
Sponsored by
Cantonal Hosptal, Baselland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Asthma

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Intervention

    Control

    Arm Description

    Patients participating in a patient education seminar

    Patients not participating in a patient education seminar

    Outcomes

    Primary Outcome Measures

    Comparison of patient characteristics between the intervention and the control group
    Comparison of asthma control between the intervention and the control group
    Asthma control is measured using the Asthma Control Test (ACT).
    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.

    Secondary Outcome Measures

    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).
    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).
    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).
    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).

    Full Information

    First Posted
    April 10, 2015
    Last Updated
    April 20, 2015
    Sponsor
    Cantonal Hosptal, Baselland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02425293
    Brief Title
    INCAS - Integrated Care of Asthma in Switzerland
    Acronym
    INCAS
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2012 (undefined)
    Primary Completion Date
    December 2014 (Actual)
    Study Completion Date
    December 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cantonal Hosptal, Baselland

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Asthma

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    223 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Intervention
    Arm Type
    Experimental
    Arm Description
    Patients participating in a patient education seminar
    Arm Title
    Control
    Arm Type
    No Intervention
    Arm Description
    Patients not participating in a patient education seminar
    Intervention Type
    Behavioral
    Intervention Name(s)
    asthma patient education
    Primary Outcome Measure Information:
    Title
    Comparison of patient characteristics between the intervention and the control group
    Time Frame
    baseline
    Title
    Comparison of asthma control between the intervention and the control group
    Description
    Asthma control is measured using the Asthma Control Test (ACT).
    Time Frame
    baseline
    Title
    Comparison of patient satisfaction between the intervention and the control group
    Description
    Patient satisfaction is measured using the Patient Assessment of Chronic Illness Care (PACIC 5A) questionnaire.
    Time Frame
    baseline
    Secondary Outcome Measure Information:
    Title
    Comparison of asthma control at baseline and after one year in the intervention group.
    Description
    Analysis of change in asthma control (using the Asthma Control Test (ACT)) in the intervention group from baseline to follow up (after one year).
    Time Frame
    baseline and follow up (after one year)
    Title
    Comparison of asthma control at baseline and after one year in the control group.
    Description
    Analysis of change in asthma control (using the Asthma Control Test (ACT)) in the control group from baseline to follow up (after one year).
    Time Frame
    baseline and follow up (after one year)
    Title
    Comparison of patient satisfaction at baseline and after one year in the intervention group.
    Description
    Analysis of change in patient satisfaction (using the PACIC 5A questionnaire) in the intervention group from baseline to follow up (after one year).
    Time Frame
    baseline and follow up (after one year)
    Title
    Comparison of patient satisfaction at baseline and after one year in the control group.
    Description
    Analysis of change in patient satisfaction (using the PACIC 5A questionnaire) in the control group from baseline to follow up (after one year).
    Time Frame
    baseline and follow up (after one year)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    59 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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)

    12. IPD Sharing Statement

    Learn more about this trial

    INCAS - Integrated Care of Asthma in Switzerland

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