Condition category
Respiratory
Date applied
28/12/2006
Date assigned
28/12/2006
Last edited
22/05/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.lumc.nl/2050/research/projsmashing.htm

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

  1. 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.

Additional files

Editorial Notes