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Effectiveness and Cost Impact of a Telecommunications System in COPD

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00012805
First received: March 14, 2001
Last updated: April 16, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention Phase
Lung Diseases, Obstructive
Procedure: Telephone Monitoring
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Effectiveness and Cost Impact of a Telecommunications System in COPD

Further study details as provided by Department of Veterans Affairs:

Estimated Enrollment: 300
Study Completion Date: March 2001
Arms Assigned Interventions
Arm 1 Procedure: Telephone Monitoring

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00012805

Locations
United States, Massachusetts
VA Boston Health Care System
Boston, Massachusetts, United States, 02130
Sponsors and Collaborators
Investigators
Principal Investigator: David William Sparrow, DSc VA Boston Health Care System
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00012805     History of Changes
Other Study ID Numbers: IIR 97-022
Study First Received: March 14, 2001
Last Updated: April 16, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2014