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

COPD Clinical Trial

Official title:

VISN 23 COPD Case Management Using Home Telehealth Equipment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00916799
• Other study ID #: 00576
• Status: Recruiting
• Phase: N/A
• First received: June 9, 2009
• Last updated: June 10, 2009
• Start date: March 2009
• Est. completion date: May 2010

Study information

• Verified date: June 2009
• Source: VA Nebraska Western Iowa Health Care System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

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

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Device:
• Use of Telehealth equipment (Viterian V-100)
Patient will daily enter answers to questions generated from a home telehealth monitor

Locations

Country	Name	City	State
United States	VA Medical Center, Minneapolis	Minneapolis	Minnesota
United States	VA Nebraska Western Iowa Healthcare System, Omaha	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (3)

Noel HC, Vogel DC, Erdos JJ, Cornwall D, Levin F. Home telehealth reduces healthcare costs. Telemed J E Health. 2004 Summer;10(2):170-83. — View Citation

Rahimpour M, Lovell NH, Celler BG, McCormick J. Patients' perceptions of a home telecare system. Int J Med Inform. 2008 Jul;77(7):486-98. Epub 2007 Nov 26. — View Citation

Vontetsianos T, Giovas P, Katsaras T, Rigopoulou A, Mpirmpa G, Giaboudakis P, Koyrelea S, Kontopyrgias G, Tsoulkas B. Telemedicine-assisted home support for patients with advanced chronic obstructive pulmonary disease: preliminary results after nine-month — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient compliance with utilizing home telehealth monitoring equipment in the two patient groups		six months	No
Primary	The amount of Home telehealth case management time utilized to provide patient monitoring in the two patient groups		six months	No
Secondary	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	No
Secondary	Evaluate patient ease of using the home telehealth equipment in the two patient groups.		six months	No
Secondary	Patient satisfaction in managing their disease in the two patient groups		six months	No
Secondary	The number of COPD exacerbations, urgent care visits, and hospitalizations related to COPD in the two patient groups		six months	No
Secondary	Correlate the effect of oxygen saturation monitoring on the early identification of COPD exacerbations		six months	No