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

VISN 23 COPD Case Management Using Home Telehealth Equipment

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.

Study Overview

• Status: Unknown
• Conditions: COPD
• Intervention / Treatment: Device: Use of Telehealth equipment (Viterian V-100)

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55417
      • Not yet recruiting
      • VA Medical Center, Minneapolis
      • Contact: Kathryn Rice, M.D.; Phone Number: 612-467-4400; Email: Kathryn.rice@va.gov
      • Contact: Mary Dahlheimer, RN; Phone Number: 612 467-4400; Email: mary.dahlheimer@va.gov
      • Sub-Investigator: Kathryn Rice, M.D.
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • Recruiting
      • VA Nebraska Western Iowa Healthcare System, Omaha
      • Contact: Naresh A Dewan, M.D.; Phone Number: 4039 402-346-8800; Email: naresh.dewan@va.gov
      • Contact: Michael C Caldwell, RN, RRT; Phone Number: 3312 402 346-8800; Email: michael.caldwell@va.gov
      • Principal Investigator: Naresh A Dewan, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Oximeter arm and non-oximetry arm	Device: Use of Telehealth equipment (Viterian V-100); Patient will daily enter answers to questions generated from a home telehealth monitor; Other Names: Viterian V-100

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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
Evaluate patient ease of using the home telehealth equipment in the two patient groups.	six months
Patient satisfaction in managing their disease in the two patient groups	six months
The number of COPD exacerbations, urgent care visits, and hospitalizations related to COPD in the two patient groups	six months
Correlate the effect of oxygen saturation monitoring on the early identification of COPD exacerbations	six months

Collaborators and Investigators

• Sponsor: US Department of Veterans Affairs
• Investigators: Principal Investigator: Naresh A Dewan, M.D., VA Nebraska Western Iowa Healthcare System, Omaha

Publications and helpful links

General Publications

• 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. doi: 10.1089/tmj.2004.10.170.
• 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 follow-up. J Telemed Telecare. 2005;11 Suppl 1:86-8. doi: 10.1258/1357633054461697.
• 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. doi: 10.1016/j.ijmedinf.2007.10.006. Epub 2007 Nov 26.

Study record dates

Study Major Dates

• Study Start: March 1, 2009
• Primary Completion (Anticipated): November 1, 2009
• Study Completion (Anticipated): May 1, 2010

Study Registration Dates

• First Submitted: June 9, 2009
• First Submitted That Met QC Criteria: June 9, 2009
• First Posted (Estimate): June 10, 2009

Study Record Updates

• Last Update Posted (Estimate): June 12, 2009
• Last Update Submitted That Met QC Criteria: June 10, 2009
• Last Verified: June 1, 2009

More Information

Terms related to this study

• Keywords: oximetry; telehealth; copd
• Other Study ID Numbers: 00576