Telecommunications System in Asthma

Asthma Clinical Trial

Official title:

Effectiveness of a Telecommunications System in Asthma Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00232557
• Other study ID #: IIR 01-054
• Status: Completed
• Phase: Phase 3
• First received: September 30, 2005
• Last updated: April 6, 2015
• Start date: August 2004
• Est. completion date: December 2009

Study information

• Verified date: October 2013
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: December 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Asthma

Intervention

Device:
• TLC-Asthma
Telephone-linked communication (TLC) designed to improve asthma self-management by enhancing compliance with preventive medication regimens
• TLC-health education
A telephone-linked communication system (TLC) to provide general health education.

Locations

Country	Name	City	State
United States	VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Participants With Unscheduled Asthma-related Visits	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	No
Secondary	Participants With Oral Corticosteroid Use	Number of participants found to have any use of oral corticosteroids related to asthma during one year	1 year	No