Self-Management of Asthma Supported by Hospitals, Information and communication technology, Nurses and General practitioners (SMASHING in adults)

ISRCTN	ISRCTN79864465
DOI	https://doi.org/10.1186/ISRCTN79864465
Protocol serial number	N/A
Sponsor	Leiden University Medical Center (LUMC) (Netherlands)
Funders	Netherlands Organisation for Health Research and Development (ZonMw), Netherlands Asthma Foundation

Submission date: 09/01/2006
Registration date: 09/01/2006
Last edited: 16/09/2013

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 Victor Meer, van der
Scientific

Leiden University Medical Center
Department of Medical Decision Making
J-10-87
P.O. Box 9600
Leiden
2300 RC
Netherlands

Phone	+31 (0)71 5264904
Email	V.van_der_Meer@lumc.nl

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study acronym	SMASHING in adults
Study objectives	A self-management programme guided by doctors and a specialist asthma nurse through information and communication technology will improve asthma related quality of life in a cost-effective way.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Asthma
Intervention	A 12-month intervention period where the patients receive either usual care or ICT-supported care guided by a specialised asthma nurse and doctor. Care strategies: 1. Usual care According to the Dutch GP guidelines, patients are invited to visit their general practitioner every 3 months in order to titrate medication to the lowest level that is needed to maintain control. This frequency can be lowered to 1-2 visits per year once control of asthma has been achieved. Thirty percent of general practices have nurse practitioners providing self-management education. Patients are referred to a chest physician if sufficient control is not achieved within 3 months. Exacerbations of asthma are treated by either chest physician and general practitioner. 1. Advise to visit to general practitioner or specialist to assess present situation 2. Review medication devices technique and adherence 3. Issue and explain paper asthma action plan, monitoring of lung function with Piko-1 spirometer 4. Plan next doctor visits as needed 2. ICT-supported care 1. Weekly monitoring of asthma control questionnaire (ACQ) and lung function through webpages and/or SMS with feedback 2. At least 6 weeks daily monitoring of lung function and symptoms with electronic feedback through webpages and/or SMS 3. Asthma self-management education in small groups (2x) by trained asthma specialist nurse (see below): i. Discussion of ACQ data in order to assess present situation and electronic asthma action plan ii. Review medication devices technique and adherence iii. Plan next doctor visits as needed 4. Virtual consulting room with asthma nurse via private messaging 5. Social support within a private chatbox and/or internet support group 6. Automated sending of reminders via email and/or SMS 7. Monitoring asthma control by lung function and ACQ with electronic data processing and feedback through computer via webpages with graphical presentation of data for patient and nurse
Intervention type	Other
Primary outcome measure(s)	1. Asthma related quality of life 2. Measurement instrument: asthma quality of life questionnaire (AQLQ) 3. Evaluation at baseline, after 3 months and after 12 months
Key secondary outcome measure(s)	1. Asthma control 2. Symptom free days 3. Exacerbations 4. Health care utilisation 5. Absence of work/school 6. Lung function 7. Exhaled nitric oxide 8. Medication use 9. Side effects
Completion date	01/03/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	50 Years
Sex	All
Target sample size at registration	250
Key inclusion criteria	1. 250 patients with mild persistent to moderate asthma (prevalent cases) 2. Age 18-50 years 3. Doctor's diagnosis of asthma 4. Asthma severity step 2-3, patients who need inhaled corticosteroids as controller medication (at least 3 months in the past year) 5. PC with internet connection available 6. Able to communicate in the Dutch language
Key exclusion criteria	1. Patients with intermittent asthma 2. Patients with severe asthma 3. Use of oral glucocorticosteroids as controller medication 4. Serious co-morbidity interfering with asthma or treatment of asthma 5. No PC or no internet connection 6. Not able to communicate in the Dutch language
Date of first enrolment	01/01/2006
Date of final enrolment	01/03/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Leiden University Medical Center

Leiden
2300 RC
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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	21/07/2009		Yes	No
Results article	results	10/06/2010		Yes	No
Results article	results	01/06/2011		Yes	No
Results article	results	12/09/2013		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes