Telecommunications System in Asthma

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2009-12-31

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.

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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TLC-Asthma

Telephone-based home education and asthma monitoring

Group Type EXPERIMENTAL

TLC-Asthma

Intervention Type DEVICE

Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens

TLC-health education

Telephone-based home education

Group Type ACTIVE_COMPARATOR

TLC-health education

Intervention Type DEVICE

A telephone-linked communication system (TLC) to provide general health education.

Interventions

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TLC-Asthma

Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens

Intervention Type DEVICE

TLC-health education

A telephone-linked communication system (TLC) to provide general health education.

Intervention Type DEVICE

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