- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00232557
Telecommunications System in Asthma
Effectiveness of a Telecommunications System in Asthma Management
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Background/Rationale:
Asthma is one of the most common chronic diseases of adults, affecting 6% of the U.S. adult population and accounting for substantial morbidity and mortality. Despite the availability of effective therapy for asthma, morbidity and mortality have increased over the last several decades. Asthma specialty care, case management, and patient education are means for improving the quality of asthma care and patient outcomes, but cost and inconvenience limit the degree to which these are used in asthma care nationally. The principal aim of this study is to evaluate the impact of an inexpensive telephone-based home education and disease monitoring system on asthma medication adherence and clinical outcomes in adult patients with asthma.
Objective(s):
We hypothesize that application of TLC to the care of adult patients with asthma will improve self-management by enhancing compliance with preventive medication regimens and fostering the use of peak flow-based action plans. This, in turn, will improve asthma control, thus reducing acute health care utilization and improving quality of life (QOL).
Methods:
A randomized controlled trial will be conducted with adult asthma patients identified from the VA Boston Healthcare System comprised of the Boston, West Roxbury, and Brockton VA Medical Centers and their associated satellite clinics. Patients will be randomized to either the TLC-Asthma group or an attention placebo control group. Outcome measurements will include medication adherence, QOL, utilization of urgent care services, oral corticosteroid use.
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02130
- VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Physician diagnosis of asthma
- Receiving treatment with one or more daily controller (i.e., preventive) medications
- Age = 18 years
- Less than 30 pack years of cigarette smoking
- FEVi greater than 50% of predicted
- FEVi bronchodilator response of at least 12%
- Ability to use a telephone without assistance
Exclusion Criteria:
N/A
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: TLC-Asthma
Telephone-based home education and asthma monitoring
|
Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens
|
ACTIVE_COMPARATOR: TLC-health education
Telephone-based home education
|
A telephone-linked communication system (TLC) to provide general health education.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants With Unscheduled Asthma-related Visits
Time Frame: 1 year
|
Number of participants found to have any unscheduled office visits, emergency room visits, or hospitalizations that are related to asthma during one year.
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Participants With Oral Corticosteroid Use
Time Frame: 1 year
|
Number of participants found to have any use of oral corticosteroids related to asthma during one year
|
1 year
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIR 01-054
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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