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ISRCTN
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ISRCTN79864465
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DOI
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10.1186/ISRCTN79864465
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Self-Management of Asthma Supported by Hospitals, Information and communication technology, Nurses and General practitioners (SMASHING in adults)
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Scientific title
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Acronym
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SMASHING in adults
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Asthma
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/01/2006
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Anticipated end date
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01/03/2008
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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250
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Interventions
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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
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Primary outcome measure(s)
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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
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Secondary outcome measure(s)
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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
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Sources of funding
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1. Netherlands Organisation for Health Research and Development (ZonMw)
2. Netherlands Asthma Foundation
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Trial website
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Publications
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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
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Contact name
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Dr
Victor
Meer, van der
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Address
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Leiden University Medical Center
Department of Medical Decision Making
J-10-87
P.O. Box 9600
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City/town
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Leiden
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Zip/Postcode
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2300 RC
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Country
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Netherlands
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Tel
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+31 (0)71 5264904
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Fax
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+31 (0)71 5266838
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Email
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V.van_der_Meer@lumc.nl
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Sponsor
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Leiden University Medical Center (LUMC) (Netherlands)
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Address
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Albinusdreef 2
P.O. Box 9600
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City/town
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Leiden
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Zip/Postcode
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2300 RC
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Country
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Netherlands
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Date applied
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09/01/2006
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Last edited
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12/04/2012
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Date ISRCTN assigned
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09/01/2006
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