Contact information
Type
Scientific
Primary contact
Dr Claudia Steurer-Stey
ORCID ID
Contact details
University Hospital Zurich
Centre for Interdisciplinary Patient Education
Zurich
8091
Switzerland
claudia.stey@usz.ch
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
New methods are needed to improve adherence of asthma patients to a written personal action plan. With this trial we aim to provide evidence about the usefulness of an asthma unspecific educational course to achieve the goal of better adherence.
Ethics approval
Cantonal Ethics Committee of the Canton Zurich, approved on the 18th October 2005 (ref: KEK-StV-Nr:29/05).
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Asthma
Intervention
Zurich Resource Model (ZRM) training:
ZRM is thought to motivate the patient and to enable the patient to sense and interpret signs of deterioration more adequately and thereby improves the adherence in following the action plan. The ZRM model is based on findings in neurosciences and psychological theory. The ZRM model integrates treatment strategies from psychological as well as behavioral, body-oriented, and supportive-humanistic methods. ZRM training follows a specific manual and is suitable equally for work with individuals and with groups, with adolescents and adults. Patients randomised to the ZRM group have a two day ZRM training in an outpatient setting followed by three ZRM refreshers of two hours for a repetition of important concepts after four, ten and 14 weeks.
Control group with usual care:
Usual care means treatment according to asthma guidelines which consists of clinical visits, adequate treatment and education in self-management with instruction in a personal Peak Expiratory Flow (PEF) and symptom based action plan. Patient education will include three main dimensions, knowledge (pathophysiology of the disease, effects and side effects of drugs) skills (inhalation technique and peak flow/symptom monitoring) and behaviour (instruction in the use of a written action plan, self-management). All patients included in the study will get that kind of patient education in a uniform defined way at the Medical Policlinic and Centre for interdisciplinary patient education. Part of the education (knowledge, inhalation technique, use of a peak-flow meter and monitoring) will be delivered in group trainings, while self-management with a personal action plan will be instructed individually.
Assessments will be made after one, three, six and 12 months.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
To assess if patients with not optimally controlled asthma, who are treated according to GINA Guidelines and who participate in a ZRM course better adhere to:
1. Self-monitoring (PEF and symptoms);
2. Self-management according to the written personal action plan; and
3. Preventive strategies for known personal triggers, compared with patients treated according to GINA Guidelines alone.
Secondary outcome measures
To assess whether asthma patients participating in the ZRM training achieve better patient-assessed asthma control (asthma control questionnaire) and motivation and self-efficacy for self-management.
Overall trial start date
04/10/2005
Overall trial end date
04/02/2007
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Males and females of full legal age (18 years old and elder)
2. Persistent not optimally controlled asthma according to the Global Initiative on Asthma (GINA) guidelines (symptoms during day, or night time symptoms, or limitation in daily activities or sports because of asthma, or need for rescue medication or unscheduled visits due to exacerbations in the last six months)
3. Asthma is defined by history, symptoms and more than 12% reversibility of airflow obstruction after beta2-mimetika inhalation
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
1. Psychiatric diagnosis such as major depression, schizophrenia, substance abuse or personality disorders
2. Other lung diseases: Chronic Obstructive Pulmonary Disease (COPD), lung cancer, fibrosis, sarcoidosis
3. Insufficient knowledge of German language to follow Zurich Resource Model (ZRM) course and/or to complete questionnaires
Recruitment start date
04/10/2005
Recruitment end date
04/02/2007
Locations
Countries of recruitment
Switzerland
Trial participating centre
University Hospital Zurich
Zurich
8091
Switzerland
Sponsor information
Organisation
AstraZeneca (Switzerland)
Sponsor details
Grafenau 10
Zug
6301
Switzerland
+41 41 7257575
info@astrazeneca.ch
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AstraZeneca (Switzerland)
Alternative name(s)
AstraZeneca PLC
Funding Body Type
private sector organisation
Funding Body Subtype
For-profit companies (industry)
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list