|- candidate number||8925|
|- NTR Number||NTR2689|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||11-jan-2011|
|- Secondary IDs|| |
|- Public Title||Virtual Asthma Clinic for Children.|
|- Scientific Title||Can the introduction of a virtual asthma clinic improve the number of asthma free days in children with asthma while reducing visits to the outpatient clinic by 50%?|
|- ACRONYM||Virtual Asthma Clinic|
|- hypothesis||The introduction of a virtual asthma clinic may improve the number of asthma free days in children with asthma while the number of visits to the outpatient clinic is decreased by 50%.|
|- Healt Condition(s) or Problem(s) studied||Asthma, Children, Selfmanagement, Management, Virtual Clinic, Digital Care|
|- Inclusion criteria||1. Children with doctor’s diagnosed asthma (based on clinical symptoms, bronchodilator response of FEV1 of > 9% of predicted and/or airway hyperresponsiveness and/or signs of chronic airways inflammation (elevated FENO));|
2. At least one allergy for airborne allergens proven by positive skin prick tests and/or blood tests;
3. Between 6 and 18 years of age;
4. Have a computer with internet connection at home.
|- Exclusion criteria||1. A history of admission to the intensive care unit for asthma in the preceding 5 years;|
2. Difficult to treat asthma (defined as uncontrolled or poorly controlled asthma in spite of maintenance treatment with inhaled corticosteroids with at least 800 micrograms budesonide or equivalent per day, long acting bronchodilators and/or Montelukast®, and/or oral corticosteroids);
3. Use of Omalizumab® for severe allergic asthma;
4. Other chronic diseases;
5. Inability of the parents or older children to understand or read Dutch.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2011|
|- planned closingdate||30-aug-2012|
|- Target number of participants||210|
|- Interventions||Randomized allocation tot usual care (outpatient clinic vist every 4 months) or access to virtual asthma clinic (outpatient clinic visits every 8 months).
The virtual asthma clinic consist of a website, accesible for all patients, their parents and their doctor’s. It has three modules:
1. An extended educational/informational module with backgroundinformation on asthma en used medication along with instructive video’s;
2. A forum on which questions can be asked and tips can be shared;
3. A shielded privat module on which the personal treatment (maintenance and attack treatment) can be consulted and on which de patient or parent freely, easily and always can communicate with the doctor. Answers are given within 24 hours on working days.
Patients receive an email every 4 weeks requesting to fill in the Astma Controle Test online, a short questionnaire, so doctor’s can monitor the degree of asthma. Results are online available for patients. When asthma control is insufficient, the treatment team will contact the patient for discussion and, if necessary, extra measurements are taken. The current contactdetails can also be found in this section.
|- Primary outcome||The number of asthma free days during the last 4 weeks of the study.|
|- Secondary outcome||1. Forced expiratory volume in one second (FEV1);|
2. Exhaled fraction of Nitric Oxide (FENO);
3. Results of the Asthma control test (ACT-questionnaire) at 0, 8 and 16 months;
4. Hospital admissions;
5. Unscheduled health visits;
7. Additional contacts or visits with the asthma management team or general physician;
8. Courses of prednisolone.
|- Timepoints||1. Start inclusion: September 2011;|
2. Stop inclusion: August 2011.
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. J. Roukema|
|- CONTACT for SCIENTIFIC QUERIES||Dr. J. Roukema|
|- Sponsor/Initiator ||University Medical Center St. Radboud|
(Source(s) of Monetary or Material Support)
|Longfonds The Netherlands , Innovatiefonds zorgverzekeraars|
|- Brief summary||Background: |
Pediatric asthma management has evolved considerably over the last decades. In addition to published guidelines and improved modes of administration for medication, much attention is now spent on adherence to treatment, quality of life, and self-management. Web-based digital tools have been shown to improve asthma knowledge, management, and outcome when added to usual care. It has not been investigated whether these tools may substitute regular visits to the outpatient clinic, and still improve asthma outcome in children and adolescents.
To assess whether asthma control can be improved through a virtual asthma clinic for children with asthma, while reducing the regular visits to the outpatient clinic by 50%.
Prospective, national, multicenter (n=7) randomized trial in which asthma management of children with allergic asthma, aged 6-18 years, through a virtual clinic will be compared with usual care. Children will be randomized into usual care (n=105) or partly digital care (n=105) through the virtual asthma clinic. Asthma treatment is in agreement with Dutch asthma management guidelines, but to correct for subtle differences between centers, randomization will be performed per center.
The primary endpoint is the number of symptom free days per month at the end of the study.
Secondary endpoints are: number of exacerbations, hospital admissions, unscheduled visits, and adherence to treatment, daily dose of ICS, quality of life, asthma control score and patient empowerment. Furthermore, cost-effectiveness will be analyzed.
|- Main changes (audit trail)|
|- RECORD||11-jan-2011 - 28-jan-2011|