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NCT00012805 Clinical Trial

Effectiveness and Cost Impact of a Telecommunications System in COPD

Lung Diseases, Obstructive Clinical Trial

Official title:
Effectiveness and Cost Impact of a Telecommunications System in COPD

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00012805
Other study ID # IIR 97-022
Secondary ID
Status Completed
Phase Phase 4
First received March 14, 2001
Last updated April 6, 2015
Est. completion date March 2001

Study information
Verified date February 2007
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

Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses among veterans in the adult population, and accounts for substantial morbidity and mortality in this population. Interventions that enhance symptom self-monitoring and increase understanding of COPD therapy may lead to earlier detection of clinical deterioration permitting more timely intervention by health care providers. However, such interventions are labor-intensive and expensive, and typically require patients to go to a medical facility on a regular basis. A novel means of providing such interventions is a Telephone-Linked Computer (TLC) system, a computer-based telecommunications system that can monitor, educate, and counsel patients through regular automated conversations in patients� homes. In previous studies, we have demonstrated the applicability of TLC technology in the clinical monitoring of adults with chronic disease conditions such as hypertension and hypercholesterolemia.

Description:

Background:

Chronic obstructive pulmonary disease (COPD) is one of the most common chronic illnesses among veterans in the adult population, and accounts for substantial morbidity and mortality in this population. Interventions that enhance symptom self-monitoring and increase understanding of COPD therapy may lead to earlier detection of clinical deterioration permitting more timely intervention by health care providers. However, such interventions are labor-intensive and expensive, and typically require patients to go to a medical facility on a regular basis. A novel means of providing such interventions is a Telephone-Linked Computer (TLC) system, a computer-based telecommunications system that can monitor, educate, and counsel patients through regular automated conversations in patients� homes. In previous studies, we have demonstrated the applicability of TLC technology in the clinical monitoring of adults with chronic disease conditions such as hypertension and hypercholesterolemia.

Objectives:

The objectives of the study were to determine whether a telecommunications system for COPD care (TLC-COPD) leads to improvements in functional status and quality of life (QOL) as well as to reductions in health care utilization and costs exceeding the TLC intervention.

Methods:

The study was designed in the form of a randomized controlled trial involving subjects with COPD who receive care at two Boston-area VA hospitals. Subjects were assigned to either TLC-COPD or a usual care control group.

Status:

Complete.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date March 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility Inclusion Criteria:

COPD diagnosis; FEV, < _65% pred; FEV, /FVC<_85% pred

Exclusion Criteria:

Study Design

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Telephone Monitoring

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, 

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