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Telecommunications System in Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00232557
First received: September 30, 2005
Last updated: April 15, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Asthma
Device: TLC-Asthma
Device: TLC-health education
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Effectiveness of a Telecommunications System in Asthma Management

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Participants With Unscheduled Asthma-related Visits [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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:
  • Participants With Oral Corticosteroid Use [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    Number of participants found to have any use of oral corticosteroids related to asthma during one year


Enrollment: 136
Study Start Date: August 2004
Study Completion Date: December 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00232557

Locations
United States, Massachusetts
VA Boston Health Care System
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: David William Sparrow, DSc VA Boston Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00232557     History of Changes
Other Study ID Numbers: IIR 01-054
Study First Received: September 30, 2005
Results First Received: November 27, 2013
Last Updated: April 15, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Asthma
Disease Management
Telecommunications
Health Services
Quality of Life
Patient Compliance

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 20, 2014