The Virtual Asthma Clinic (VAC)
|First Received Date ICMJE||November 20, 2007|
|Last Updated Date||January 4, 2010|
|Start Date ICMJE||March 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00562081 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||The Virtual Asthma Clinic|
|Official Title ICMJE||Evaluation of an Internet-based Approach to Long-term Treatment of Asthma.|
Patients with asthma can be effectively treated using an Internet-based management system as demonstrated by:
Effective patient education will be associated with decreased markers of inflammation and improved indices of airways function.
Over a one-year period, we will evaluate specific outcomes related to the use of the internet-based asthma treatment plans. Patients identified by their physician as candidates for the study will be screened by the CAE. All subjects will be provided with an information sheet and will be asked to sign an informed consent. All subjects asthma treatment will be reviewed for adequacy of medical management (as defined by the Canadian Consensus Guidelines for Asthma Care) and may have treatment adjusted by one of the study physician specialists to ensure compliance with guideline-based best practice if necessary
Following obtaining consent, all subjects will receive identical standardized education. This will include: review of medications and inhaler device technique, review any environmental triggers, and generate a written action plan. All subjects will receive a peak flow meter and will be instructed in its use. All subjects will undergo baseline pulmonary function tests if they have not had one conducted in the previous six months that will include flow-volume loops pre and post bronchodilator. Subjects that do not demonstrate a 12% improvement in FEV1 post bronchodilator will also have a methacholine challenge test to assess airway hyperreactivity. A urine sample will be obtained and frozen for subsequent NMR spectroscopy. Standard demographic information will be obtained from all subjects including smoking status, age, education status, and weight assessed as BMI. Subjects successfully completing screening tests and fulfilling inclusion and exclusion criteria will be randomly allocated to either to the active therapy using the Internet site, or to a placebo therapy using a web-based intervention. Randomization will occur using an internet based program created by the EPICORE Centre at the University of Alberta.
All subjects will be given an individualized access code and the website address and will receive a brief demonstration of the website. Following initial log-on to the website the subject's in the intervention group will have their asthma profile reviewed daily by a Certified Asthma Educator (CAE). Patients who do not log-on to the website within 1 week of randomization will be contacted by telephone. The intervention group will have access to the full version of the website with access to the CAE and they will be expected to enter daily symptoms, evening and morning peak flows and medication use under their subject profile. Patients who consent but do not log-on despite additional telephone contact will be deemed as an immediate compliance failure. Otherwise patients' individual profiles will be evaluated until the end of the 12-month period. Non-compliance to the asthma management program will be defined as:
The internet-based system will utilize a secure website to deliver the following to the intervention group: 1) ongoing patient education, 2) regular feedback regarding significance of symptoms, 3) regular feedback regarding significance of peak flows, and 4) a written action plan. Patients will also have their individual files monitored regularly by a CAE. Finally patients in the intervention group will have on-line access to an asthma educator through a secure email system.
The placebo web-based intervention will include basic patient information on asthma and asthma management; however will not include an interactive component. They would not have personalized information tracked on the asthma management website, however they will be asked to complete the outcome measurements at regularly scheduled intervals online. All subjects will be sent regular email reminders to continue to log into the program and complete the outcome measures. These reminders will be sent at regular intervals and include basic information on asthma to encourage participation.
All patients will be requested to provide their Alberta Health Care Insurance Plan Number to allow access to their individualized health care utilization data from Capital Health and the Calgary Regional Health Authority. In particular, clinic visits; emergency room visits; and hospitalization data will be requested from the health regions. Patients will also be asked to provide a copy of their prescription records for the duration of the study. All data will be entered into a SPSS database and will be analyzed using this and other statistical programs. Data analysis will be conducted by EPICORE at the University of Alberta.
All subjects will be monitored via website for one year. All subjects will be asked to complete the 15D and AQLQ at baseline, six months post enrollment and 12 months post enrollment. Additionally, they will be asked to complete the Weekly Survey every two months. The intervention group only will be asked to complete the symptom survey at each login, as it is used primarily for clinical reasons by the CAE. All subjects will have seven days to complete and submit the outcome measures and reminders will be sent via email every second day. If a subject fails to complete the measurements within the seven-day period, they will receive a phone call reminder. Subjects will be asked to return 12 months post enrollment to the clinic for repeated spirometry testing and a second urine sample collection. No additional office visits are anticipated.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
|Study Arm (s)||
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Suspended|
|Estimated Completion Date||June 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 70 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Canada|
|NCT Number ICMJE||NCT00562081|
|Other Study ID Numbers ICMJE||M-2394|
|Has Data Monitoring Committee||No|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Alberta|
|Information Provided By||University of Alberta|
|Verification Date||January 2009|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP