SMASHING in adolescents.

• Register: Netherlands Trial Register
• Last refreshed on: 27 May 2013
• Main ID: NTR826
• Date of registration: 24/11/2006
• Primary sponsor: Leiden University Medical Center (LUMC)
• Public title: SMASHING in adolescents.
• Scientific title: SMASHING in adolescents: Self-Management of Asthma Supported by Hospitals, Information and communication technology, Nurses and General practitioners. - SMASHING
• Date of first enrolment: 15/12/2006
• Target sample size: 124
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=826
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Active; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: Jaap K. Sont

• Name: H.F. Stel, van

Key inclusion & exclusion criteria

Inclusion criteria: 1. Age 12-17 yr;
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-score >= 1 or Asthma Control Questionnaire >= 1.0);
5. Able to communicate in the Dutch language.
Exclusion criteria: Patients requiring oral corticosteroids as controller medication and patients with relevant comorbidity will be excluded.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

ICT-supported care:
1. Asthma self-management education in small groups (2 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 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 (20). 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 3 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.

Primary Outcome(s)

Health related quality of life as measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).

Secondary Outcome(s)

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.

Secondary ID(s)

ISRCTN11633371

N/A

Source(s) of Monetary Support

Astmafonds The Netherlands