Telecommunications System in Asthma

April 6, 2015 updated by: US Department of Veterans Affairs

Effectiveness of a Telecommunications System in Asthma Management

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

136

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02130
        • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

US Department of Veterans Affairs

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2004

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

September 30, 2005

First Submitted That Met QC Criteria

September 30, 2005

First Posted (ESTIMATE)

October 4, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

April 24, 2015

Last Update Submitted That Met QC Criteria

April 6, 2015

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IIR 01-054

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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