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Completed

NCT Number: NCT00232557

Telecommunications System in Asthma

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, 02130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

TLC-Asthma

Device

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

TLC-health education

Device

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Registry information

Official study title

Effectiveness of a Telecommunications System in Asthma Management

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Oct 4, 2005
Registry last updated
Apr 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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