SMASHING in adolescents: Self-Management of Asthma Supported by Hospitals, Information and communication technology, Nurses and General practitioners
| ISRCTN | ISRCTN11633371 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11633371 |
| Secondary identifying numbers | N/A |
- Submission date
- 28/12/2006
- Registration date
- 28/12/2006
- Last edited
- 22/05/2013
- 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 Jacob K. Sont
Scientific
Scientific
Department of Medical Decision Making, J10-86
Leiden University Medical Center
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Phone | +31 (0)71 526 4578 |
|---|---|
| j.k.sont@lumc.nl |
Study information
| Study design | Randomised, controlled, parallel group, multicentre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SMASHING |
| 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) | Approval received from the local ethics committee (Commissie Medische Ethiek) on the 7th August 2006 (reference number: P06.110). |
| Health condition(s) or problem(s) studied | Asthma |
| Intervention | Please note that as of 06/02/2008 the anticipated end date of this trial was extended to 30/05/2009. The previous end date of this trial was 30/06/2008. Information and Communication Technology (ICT)-supported care: 1. Asthma self-management education in small groups (two sessions per group) by trained asthma specialist nurse: a. Discussion of ACQ and ATAQ data in order to assess present situation and electronic asthma action plan b. Review medication devices technique and adherence c. Plan next doctor visits as needed 2. Monitoring asthma control by lung function and ACQ (input via website or SMS [text messaging]) with electronic data processing and feedback through computer via webpages with graphical presentation of data for patient and nurse 3. Virtual consulting room with asthma nurse via email and private messaging 4. Social support within a private chatbox and/or internet support group 5. Automated sending of reminders via email and/or SMS Control group: usual care: According to the Dutch General Practitioner (GP) guidelines, patients are invited to visit their general practitioner every three months in order to titrate medication to the lowest level that is needed to maintain control. This frequency can be lowered to one to two 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 pediatrician/pediatric pulmonologist if sufficient control is not achieved within three months. Exacerbations of asthma are treated by either pediatrician and general practitioner: 1. Advise to visit to general practitioner or pediatrician 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 |
| Intervention type | Other |
| Primary outcome measure | Health related quality of life as measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ). |
| 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. Self-reported asthma management behaviour 10. Side effects |
| Overall study start date | 15/12/2006 |
| Completion date | 30/05/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Years |
| Upper age limit | 17 Years |
| Sex | Not Specified |
| Target number of participants | 124 |
| Key inclusion criteria | 1. Age 12 to 17 years 2. Doctors diagnosis of asthma 3. Mild to severe persistent asthma (patients who need inhaled corticosteroids as controller medication) 4. At least one asthma control problem (Asthma Therapy Assessment Questionnaire [ATAQ] score more than or equal to one or Asthma Control Questionnaire [ACQ] more than or equal to one) 5. Able to communicate in the Dutch language |
| Key exclusion criteria | Patients requiring oral corticosteroids as controller medication and patients with relevant comorbidity will be excluded. |
| Date of first enrolment | 15/12/2006 |
| Date of final enrolment | 30/05/2009 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Department of Medical Decision Making, J10-86
Leiden
2300 RC
Netherlands
2300 RC
Netherlands
Sponsor information
Leiden University Medical Center (LUMC) (Netherlands)
Hospital/treatment centre
Hospital/treatment centre
P.O. Box 9600
Leiden
2300 RC
Netherlands
| Website | http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html |
|---|---|
"ROR" |
https://ror.org/05xvt9f17 |
Funders
Funder type
Research organisation
Astmafonds (Netherlands)
No information available
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 | 01/12/2012 | Yes | No |
