Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Dr Jacob K. Sont
ORCID ID
Contact details
Department of Medical Decision Making
J10-86
Leiden University Medical Center
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 526 4578
j.k.sont@lumc.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
SMASHING
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
Approval received from the local ethics committee (Commissie Medische Ethiek) on the 7th August 2006 (reference number: P06.110).
Study design
Randomised, controlled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
15/12/2006
Overall trial end date
30/05/2009
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
124
Participant exclusion criteria
Patients requiring oral corticosteroids as controller medication and patients with relevant comorbidity will be excluded.
Recruitment start date
15/12/2006
Recruitment end date
30/05/2009
Locations
Countries of recruitment
Netherlands
Trial participating centre
Department of Medical Decision Making, J10-86
Leiden
2300 RC
Netherlands
Sponsor information
Organisation
Leiden University Medical Center (LUMC) (Netherlands)
Sponsor details
P.O. Box 9600
Leiden
2300 RC
Netherlands
Sponsor type
Hospital/treatment centre
Website
http://www.lumc.nl/english/start_english.html#http://www.lumc.nl/english/start_english.html
Funders
Funder type
Research organisation
Funder name
Astmafonds (Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22644646
Publication citations
-
Results
Rikkers-Mutsaerts ER, Winters AE, Bakker MJ, van Stel HF, van der Meer V, de Jongste JC, Sont JK, , Internet-based self-management compared with usual care in adolescents with asthma: a randomized controlled trial., Pediatr. Pulmonol., 2012, 47, 12, 1170-1179, doi: 10.1002/ppul.22575.