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The Virtual Asthma Clinic (VAC)

This study has suspended participant recruitment.
(Poor recruitment.)
Sponsor:
Collaborators:
ASTHMA C Project
AstraZeneca
GlaxoSmithKline
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00562081
First received: November 20, 2007
Last updated: January 4, 2010
Last verified: January 2009
History of Changes
  Purpose

Patients with asthma can be effectively treated using an Internet-based management system as demonstrated by:

  1. Physician utilization (emergency department visits and unscheduled physician visits).
  2. Health-related quality of life scores.
  3. Global health care costs.
  4. Frequency of severe exacerbations and time to first exacerbation.
  5. Asthma control days.
  6. Patient education.

Effective patient education will be associated with decreased markers of inflammation and improved indices of airways function.


Condition Intervention Phase
Asthma
 Behavioral: Education
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Evaluation of an Internet-based Approach to Long-term Treatment of Asthma.

Resource links provided by NLM:

MedlinePlus related topics: Asthma
U.S. FDA Resources

Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Emergency department visits and unscheduled physician visits [ Time Frame: One year. ]
  • Good asthma control days [ Time Frame: One year. ]
  • Time to first severe exacerbation [ Time Frame: One year. ]

Secondary Outcome Measures:
  • Morning peak expiratory flow [ Time Frame: One year. ]
  • Percentage of days with symptoms [ Time Frame: One year. ]
  • Percentage of nights with asthma awakenings [ Time Frame: One year. ]
  • Number of rescue inhalations per week [ Time Frame: One year. ]
  • Health related quality of life scores [ Time Frame: One year. ]
  • Markers of inflammation: Airway hyperreactivity, Urine metabolic activity [ Time Frame: One year. ]
  • Health economic assessment: Frequency of direct health care provider contacts, Medications, Travel costs associated with medical care, Over the counter medications e. Internet/computer costs [ Time Frame: One year. ]

Enrollment: 27
Study Start Date: March 2005
Estimated Study Completion Date: June 2007
Arms Assigned Interventions
Placebo Comparator: 1
Patient does not have 24/7 access to a Certified Asthma Educator.
 Behavioral: Education
Patient does not have 24/7 access to a Certified Asthma Educator.
Active Comparator: 2
Patient has 24/7 access to a Certified Asthma Educator.
 Behavioral: Education
24/7 access to a Certified Asthma Educator

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Physician diagnosis of asthma at the time of enrolment.
  2. The forced expiratory volume in one second (FEV1) at base line will be at least 50 percent of the predicted value.
  3. Evidence of at least 12% increase in FEV1 following inhaled bronchodilator or airway hyperreactivity as defined by a standard methacholine challenge study.

Exclusion Criteria:

  1. Concurrent disease likely to require regular physician contact (e.g. congestive heart failure).
  2. A separate diagnosis or other pulmonary disease (e.g. pulmonary fibrosis or chronic bronchitis).
  3. An inability to access the Internet on a regular basis.
  4. Inability or unwillingness to give informed consent or to complete online health related quality of life questionnaires.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562081

Locations
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Sponsors and Collaborators
University of Alberta
ASTHMA C Project
AstraZeneca
GlaxoSmithKline
Investigators
Principal Investigator: Irvin Mayers, MD, FRCPC University of Alberta
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00562081     History of Changes
Other Study ID Numbers: M-2394
Study First Received: November 20, 2007
Last Updated: January 4, 2010
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

Keywords provided by University of Alberta:
asthma
Virtual Asthma Clinic
metabolites
asthma education

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013