|- candidate number||2338|
|- NTR Number||NTR826|
|- Date ISRCTN created||28-dec-2006|
|- date ISRCTN requested||18-dec-2006|
|- Date Registered NTR||24-nov-2006|
|- Secondary IDs||N/A |
|- 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.|
|- 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.|
|- Healt Condition(s) or Problem(s) studied||Asthma|
|- 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.|
|- mec approval received||yes|
|- multicenter trial||yes|
|- planned startdate ||15-dec-2006|
|- planned closingdate||30-jun-2008|
|- Target number of participants||124|
|- Interventions||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||Health related quality of life as measured by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).|
|- Secondary outcome||1. Asthma control;
2. Symptom free days;
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.|
|- Trial web site||http://www.lumc.nl/2050/research/projsmashing.htm|
|- CONTACT FOR PUBLIC QUERIES||Dr. H.F. Stel, van|
|- CONTACT for SCIENTIFIC QUERIES||PhD. MD. Jaap K. Sont|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|Astmafonds The Netherlands |
|- Brief summary||Objective
1. To improve patient's quality of life in a cost-effective way by a self-management programme guided by doctors and a specialist asthma nurse through information and communication technology.
A. What is the cost-effectiveness of a self-management programme in adult patients with mild to moderated asthma facilitated by information and communication technology and supported by health care professionals in order to improve quality of life?
B. Does this self-management programme lead to improved asthma related quality of life?
A randomised parallel trial with 2 arms and 1 year follow-up in 2 phases in order to compare ICT-supported care with usual care.
The first phase serves as a baseline period and is solely aimed at collecting data on asthma control and behaviour and lifestyle, and predisposing, reinforcing and enabling factors.
The second phase includes the intervention and evaluation period.
Patients with mild to moderate persistent asthma, aged between 12 and 17, will be identified via the LUMC general practice network and hospital information systems. Patients have access to a computer with an internet-connection and are able to communicate in the Dutch language.
The current intervention is additional to usual care and includes monitoring of symptoms and lung function and communication of results, feedback and reminders via internet and short message services on telephones.
The service is supervised by a specialised nurse and facilitates discussion groups, a chat box and consultation via private messaging. Asthma self-management education and training sessions are given by a specialist nurse.
The primary and secondary outcome are health related quality of life (PAQLQ) and asthma control (ACQ), respectively.
Sample size calculation
Using 50 patients per arm and a SD of changes in PAQLQ-score of 0.9 we are able to detect a minimally important difference of 0.5 points between PAQLQ-changes of the two arms (alphap = 0.05 two-sided, beta = 0.20 one-sided). Adjusting the sample size for an expected 10% nonadherence requires to increase the group size to 62.
The costs of usual care and ICT-supported care will be compared from a societal perspective. In a cost-utility analysis, the difference in societal costs will be related to the estimate difference in QALYs using acceptability curves. A Markov model will be used to extrapolate the trial data to a 3 year period.|
|- Main changes (audit trail)|
|- RECORD||24-nov-2006 - 29-dec-2006|