Condition category
Respiratory
Date applied
09/01/2006
Date assigned
09/01/2006
Last edited
16/09/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Victor Meer, van der

ORCID ID

Contact details

Leiden University Medical Center
Department of Medical Decision Making
J-10-87
P.O. Box 9600
Leiden
2300 RC
Netherlands
+31 (0)71 5264904
V.van_der_Meer@lumc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/01/2006

Overall trial end date

01/03/2008

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

250

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

Trial participating centre

Leiden University Medical Center
Leiden
2300 RC
Netherlands

Sponsor information

Organisation

Leiden University Medical Center (LUMC) (Netherlands)

Sponsor details

Albinusdreef 2
P.O. Box 9600
Leiden
2300 RC
Netherlands

Sponsor type

Not defined

Website

Funders

Funder type

Research council

Funder name

Netherlands Organisation for Health Research and Development (ZonMw)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Netherlands Asthma Foundation

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. 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
4. 2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24028826

Publication citations

  1. Results

    van der Meer V, van Stel HF, Bakker MJ, Roldaan AC, Assendelft WJ, Sterk PJ, Rabe KF, Sont JK, , Weekly self-monitoring and treatment adjustment benefit patients with partly controlled and uncontrolled asthma: an analysis of the SMASHING study., Respir. Res., 2010, 11, 74, doi: 10.1186/1465-9921-11-74.

  2. Results

    van der Meer V, van den Hout WB, Bakker MJ, Rabe KF, Sterk PJ, Assendelft WJ, Kievit J, Sont JK, , Cost-effectiveness of Internet-based self-management compared with usual care in asthma., PLoS ONE, 2011, 6, 11, e27108, doi: 10.1371/journal.pone.0027108.

  3. Results

    van Gaalen JL, Beerthuizen T, van der Meer V, van Reisen P, Redelijkheid GW, Snoeck-Stroband JB, Sont JK, , Long-term outcomes of internet-based self-management support in adults with asthma: randomized controlled trial., J. Med. Internet Res., 2013, 15, 9, e188, doi: 10.2196/jmir.2640.

  4. van der Meer V, Bakker MJ, van den Hout WB, Rabe KF, Sterk PJ, Kievit J, Assendelft WJ, Sont JK, , Internet-based self-management plus education compared with usual care in asthma: a randomized trial., Ann. Intern. Med., 2009, 151, 2, 110-120.

Additional files

Editorial Notes