Self-Management of Asthma Supported by Hospitals, Information and communication technology, Nurses and General practitioners (SMASHING in adults)
ISRCTN | ISRCTN79864465 |
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DOI | https://doi.org/10.1186/ISRCTN79864465 |
Secondary identifying numbers | N/A |
- 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
Not provided at time of registration
Contact information
Dr Victor Meer, van der
Scientific
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 |
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V.van_der_Meer@lumc.nl |
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Other |
Study type | Quality of life |
Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
Scientific title | |
Study acronym | SMASHING in adults |
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. |
Ethics approval(s) | Not provided at time of registration |
Condition | 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 | 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 measures | 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 |
Overall study start date | 01/01/2006 |
Overall study end date | 01/03/2008 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Upper age limit | 50 Years |
Sex | Both |
Target number of participants | 250 |
Participant 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 |
Participant 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 |
Recruitment start date | 01/01/2006 |
Recruitment end date | 01/03/2008 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Leiden University Medical Center
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (Netherlands)
Not defined
Not defined
Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands
https://ror.org/05xvt9f17 |
Funders
Funder type
Research council
Netherlands Organisation for Health Research and Development (ZonMw)
Private sector organisation / Other non-profit organizations
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- Netherlands Organisation for Health Research and Development
- Location
- Netherlands
Netherlands Asthma Foundation
No information available
Results and Publications
Intention to publish date | |
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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 | 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 |