Telecommunications System in Asthma

Study Overview
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Brief Summary
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This project is investigating whether application of a telecommunications system 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.

Detailed Description
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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.

Official Title
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Effectiveness of a Telecommunications System in Asthma Management

Conditions
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Asthma

Intervention / Treatment
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* Device: TLC-Asthma
* Device: TLC-health education


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TLC-Asthma<br>Telephone-based home education and asthma monitoring | Device: TLC-Asthma<br>* Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens<br>|
| Active Comparator: TLC-health education<br>Telephone-based home education | Device: TLC-health education<br>* A telephone-linked communication system (TLC) to provide general health education.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants With Unscheduled Asthma-related Visits | 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 | Number of participants found to have any use of oral corticosteroids related to asthma during one year | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Disease Management, Telecommunications, Health Services, Quality of Life, Patient Compliance