Telecommunications System in Asthma

Phase 3

Completed

• Conditions: Asthma
• Interventions: Device: TLC-Asthma; Device: TLC-health education

• Registration Number: NCT00232557
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2005-09-30
• Study First Submitted QC: 2005-09-30
• Study First Posted: 2005-10-04
• Primary Completion: 2009-07
• Study Completion: 2009-12
• Status Verified: 2013-10
• Results First Submitted: 2013-11-27
• Results First Submitted QC: 2014-01-16
• Results First Posted: 2014-02-13
• Last Update Submitted: 2015-04-06
• Last Update Posted: 2015-04-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

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Exclusion Criteria

N/A

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TLC-Asthma	TLC-Asthma	Telephone-based home education and asthma monitoring
TLC-health education	TLC-health education	Telephone-based home education

Primary Outcome Measures

Name	Time	Method
Participants With Unscheduled Asthma-related Visits	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.

Secondary Outcome Measures

Name	Time	Method
Participants With Oral Corticosteroid Use	1 year	Number of participants found to have any use of oral corticosteroids related to asthma during one year

Trial Locations

Locations (1)

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA; 🇺🇸 Boston, Massachusetts, United States