Clinical trial NCT00232557: Telecommunications System in Asthma
Official title: Effectiveness of a Telecommunications System in Asthma Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: Asthma
Disease Management
Telecommunications
Health Services
Quality of Life
Patient Compliance
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2005-10-04
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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.

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 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

Primary outcomes:
measure: Participants With Unscheduled Asthma-related Visits
timeFrame: 1 year
Secondary outcomes:
measure: Participants With Oral Corticosteroid Use
timeFrame: 1 year
Other outcomes:
Locations:
city: Boston
country: United States
facility: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
state: Massachusetts
Study officials:
affiliation: VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA
name: David William Sparrow, DSc
role: PRINCIPAL_INVESTIGATOR
References: