Boston, Massachusetts 02130

  • Lung Diseases, Obstructive

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.


Study summary:

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.


Criteria:

Inclusion Criteria: COPD diagnosis; FEV, < _65% pred; FEV, /FVC<_85% pred Exclusion Criteria:


Study is Available At:


Original ID:

IIR 97-022


NCT ID:

NCT00012805


Secondary ID:


Study Acronym:


Brief Title:

Effectiveness and Cost Impact of a Telecommunications System in COPD


Official Title:

Effectiveness and Cost Impact of a Telecommunications System in COPD


Overall Status:

Completed


Study Phase:

Phase 4


Genders:

Male


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Department of Veterans Affairs


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

300


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:David William Sparrow, DSc
Principal Investigator
VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

Study Dates

Completion Date:March 2001
Completion Type:Actual
Verification Date:February 2007
Last Changed Date:April 6, 2015
First Received Date:March 14, 2001

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Procedure
Name:Telephone Monitoring
Arm Name:Arm 1

Study Arms

Study Arm Type:Other
Arm Name:Arm 1

Study Agencies

Agency Class:U.S. Fed
Agency Type:Lead Sponsor
Agency Name:Department of Veterans Affairs

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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