NCT02425293

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
223

participants targeted

Target at P75+ for not_applicable asthma

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable asthma

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 10, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 23, 2015

Completed
Last Updated

April 23, 2015

Status Verified

April 1, 2015

Enrollment Period

2.5 years

First QC Date

April 10, 2015

Last Update Submit

April 20, 2015

Conditions

Outcome Measures

Primary Outcomes (3)

  • Comparison of patient characteristics between the intervention and the control group

    baseline

  • Comparison of asthma control between the intervention and the control group

    Asthma control is measured using the Asthma Control Test (ACT).

    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.

    baseline

Secondary Outcomes (4)

  • Comparison of asthma control at baseline and after one year in the intervention group.

    baseline and follow up (after one year)

  • Comparison of asthma control at baseline and after one year in the control group.

    baseline and follow up (after one year)

  • Comparison of patient satisfaction at baseline and after one year in the intervention group.

    baseline and follow up (after one year)

  • Comparison of patient satisfaction at baseline and after one year in the control group.

    baseline and follow up (after one year)

Study Arms (2)

Intervention

EXPERIMENTAL

Patients participating in a patient education seminar

Behavioral: asthma patient education

Control

NO INTERVENTION

Patients not participating in a patient education seminar

Interventions

Intervention

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients with clinical asthma diagnosis
  • written informed consent

You may not qualify if:

  • inadequate knowledge of the German language
  • subjects with severe diseases with life expectancy under one year
  • subjects with known Chronic Obstructive Pulmonary Disease (COPD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med.

Study Record Dates

First Submitted

April 10, 2015

First Posted

April 23, 2015

Study Start

June 1, 2012

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

April 23, 2015

Record last verified: 2015-04