Effect of the Zurich resource model teaching module on adherence to self-monitoring and to the written action plan in patients with asthma: a randomised controlled trial

ISRCTN	ISRCTN33589847
DOI	https://doi.org/10.1186/ISRCTN33589847
Secondary identifying numbers	N/A

Submission date: 19/10/2006
Registration date: 20/11/2006
Last edited: 06/01/2021

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Respiratory

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Claudia Steurer-Stey
Scientific

University Hospital Zurich
Centre for Interdisciplinary Patient Education
Zurich
8091
Switzerland

Email	claudia.stey@usz.ch

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title	Effect of the Zurich resource model teaching module on adherence to self-monitoring and to the written action plan in patients with asthma: a randomised controlled trial
Study objectives	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(s)	Cantonal Ethics Committee of the Canton Zurich, approved on the 18th October 2005 (ref: KEK-StV-Nr:29/05).
Health condition(s) or problem(s) studied	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	Behavioural
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 study start date	04/10/2005
Completion date	04/02/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	60
Total final enrolment	60
Key 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
Key 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
Date of first enrolment	04/10/2005
Date of final enrolment	04/02/2007

Locations

Countries of recruitment

Switzerland

Study participating centre

University Hospital Zurich

Zurich
8091
Switzerland

Sponsor information

AstraZeneca (Switzerland)
Industry

Grafenau 10
Zug
6301
Switzerland

Phone	+41 41 7257575
Email	info@astrazeneca.ch
Website	http://www.astrazeneca.ch
"ROR"	https://ror.org/034rhks82

Funders

Funder type

Industry

AstraZeneca (Switzerland)
Government organisation / For-profit companies (industry)

Alternative name(s): AstraZeneca PLC, Pearl Therapeutics
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results		06/01/2021	Yes	No

Editorial Notes

06/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.