Effectiveness and Cost Impact of a Telecommunications System in COPD

NCT ID: NCT00012805

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Completion Date: 2001-03-31

Brief 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.

Detailed 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.

Conditions

Lung Diseases, Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

Arm 1

Group Type: OTHER

Telephone Monitoring

Intervention Type: PROCEDURE

Interventions

Telephone Monitoring

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

US Department of Veterans Affairs

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David William Sparrow, DSc

Role: PRINCIPAL_INVESTIGATOR

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Locations

VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

IIR 97-022

Identifier Type: -

Identifier Source: org_study_id