Welcome
Support Centre
01 November 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ ...Back to search results ] [ Print-friendly version ]
Self-Management of Asthma Supported by Hospitals, Information and communication technology, Nurses and General practitioners (SMASHING in adults)
ISRCTN ISRCTN79864465
DOI 10.1186/ISRCTN79864465
ClinicalTrials.gov identifier
EudraCT number
Public title Self-Management of Asthma Supported by Hospitals, Information and communication technology, Nurses and General practitioners (SMASHING in adults)
Scientific title
Acronym SMASHING in adults
Serial number at source N/A
Study hypothesis 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.
Lay summary Not provided at time of registration
Ethics approval Not provided at time of registration
Study design Randomised controlled trial
Countries of recruitment Netherlands
Disease/condition/study domain Asthma
Participants - 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
Participants - 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
Anticipated start date 01/01/2006
Anticipated end date 01/03/2008
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 250
Interventions 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
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
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
Sources of funding 1. Netherlands Organisation for Health Research and Development (ZonMw)
2. Netherlands Asthma Foundation
Trial website
Publications 1. 2009 results in: http://www.ncbi.nlm.nih.gov/pubmed/19620163
2. 2010 results in: http://www.ncbi.nlm.nih.gov/pubmed/20537124
3. 2011 results in: http://www.ncbi.nlm.nih.gov/pubmed/22096523
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24028826
Contact name Dr  Victor  Meer, van der
  Address Leiden University Medical Center
Department of Medical Decision Making
J-10-87
P.O. Box 9600
  City/town Leiden
  Zip/Postcode 2300 RC
  Country Netherlands
  Tel +31 (0)71 5264904
  Fax +31 (0)71 5266838
  Email V.van_der_Meer@lumc.nl
Sponsor Leiden University Medical Center (LUMC) (Netherlands)
  Address Albinusdreef 2
P.O. Box 9600
  City/town Leiden
  Zip/Postcode 2300 RC
  Country Netherlands
Date applied 09/01/2006
Last edited 16/09/2013
Date ISRCTN assigned 09/01/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.