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Telecommunications System in Asthma

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ClinicalTrials.gov Identifier: NCT00232557
Recruitment Status : Completed
First Posted : October 4, 2005
Results First Posted : February 13, 2014
Last Update Posted : April 24, 2015
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Brief Summary:
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 or disease Intervention/treatment Phase
Asthma Device: TLC-Asthma Device: TLC-health education Phase 3

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  (Clinical Trial)
Actual Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Effectiveness of a Telecommunications System in Asthma Management
Study Start Date : August 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00232557


Locations
United States, Massachusetts
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
VA Office of Research and Development
Investigators
Principal Investigator: David William Sparrow, DSc VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT00232557     History of Changes
Other Study ID Numbers: IIR 01-054
First Posted: October 4, 2005    Key Record Dates
Results First Posted: February 13, 2014
Last Update Posted: April 24, 2015
Last Verified: October 2013

Keywords provided by VA Office of Research and Development:
Asthma
Disease Management
Telecommunications
Health Services
Quality of Life
Patient Compliance

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