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Telecommunications System in Asthma

US Department of Veterans Affairs (VA) logo

US Department of Veterans Affairs (VA)

Status and phase

Completed
Phase 3

Conditions

Asthma

Treatments

Device: TLC-health education
Device: TLC-Asthma

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT00232557
IIR 01-054

Details and patient eligibility

About

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.

Full 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.

Enrollment

136 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

136 participants in 2 patient groups

TLC-Asthma
Experimental group
Description:
Telephone-based home education and asthma monitoring
Treatment:
Device: TLC-Asthma
TLC-health education
Active Comparator group
Description:
Telephone-based home education
Treatment:
Device: TLC-health education

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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