VISN 23 Chronic Obstructive Pulmonary Disease (COPD) Case Management Using Home Telehealth Equipment

Not Applicable

• Conditions: COPD
• Interventions: Device: Use of Telehealth equipment (Viterian V-100)

• Registration Number: NCT00916799
• Lead Sponsor: US Department of Veterans Affairs

Brief Summary

Looking at the use of home telehealth equipment and it's place in self management and education in patients who suffer moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The patients in this group would be those patients who traditionally suffer from emphysema, and/or chronic bronchitis.

Detailed Description

Patients who have been admitted to the hospital, or who have frequent urgent care visits, who also suffer from COPD exacerbations will be given a home monitoring system. Daily, the patient will respond to a series of questions. The results of the question answers will be remotely monitored by a nurse case manager.

The objective is to measure compliance, resource use, and the ability for early recognition of an exacerbation of their COPD, and early implementation of therapy.

Study Timeline

• Study Start: 2009-03
• Status Verified: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-09
• Study First Posted: 2009-06-10
• Last Update Submitted: 2009-06-10
• Last Update Posted: 2009-06-12
• Primary Completion: 2009-11
• Study Completion: 2010-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• One or more hospital admissions or emergency room visits in last 2 Years.
• Patient must meet the VA home telehealth guideline that the patient is determined to be at high risk for poor clinical outcomes or increased unplanned health care utilization based on disease specific criteria and/or determined by physician provider

Exclusion Criteria

• Any unstable medical condition that the investigator thinks would preclude effective participation in the study, or which would be expected to reduce life expectancy to less than 1 year.
• Unwilling or unable to provide consent
• Uncooperative or combative
• Does not have a compatible phone line
• Inability to use home telemedicine equipment

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oximeter arm and non-oximetry arm	Use of Telehealth equipment (Viterian V-100)	-

Primary Outcome Measures

Name	Time	Method
Patient compliance with utilizing home telehealth monitoring equipment in the two patient groups	six months
The amount of Home telehealth case management time utilized to provide patient monitoring in the two patient groups	six months

Secondary Outcome Measures

Name	Time	Method
The number of COPD exacerbations, urgent care visits, and hospitalizations related to COPD in the two patient groups	six months
Evaluate patient ease of using the home telehealth equipment in the two patient groups.	six months
Patient satisfaction The role of finger oximetry in the identification of exacerbations Number of hospitalizations and urgent care visits and how they relate to the use of home telehealth equipment	six months
Patient satisfaction in managing their disease in the two patient groups	six months
Correlate the effect of oxygen saturation monitoring on the early identification of COPD exacerbations	six months

Trial Locations

Locations (2)

VA Nebraska Western Iowa Healthcare System, Omaha; 🇺🇸 Omaha, Nebraska, United States

VA Medical Center, Minneapolis; 🇺🇸 Minneapolis, Minnesota, United States