Condition category
Respiratory
Date applied
19/10/2006
Date assigned
20/11/2006
Last edited
20/11/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.astrazeneca.ch

Funders

Funder type

Industry

Funder name

AstraZeneca (Switzerland)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

corporate

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes