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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by VA Nebraska Western Iowa Health Care System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VA Nebraska Western Iowa Health Care System
ClinicalTrials.gov Identifier:
NCT00916799
First received: June 9, 2009
Last updated: June 10, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
COPD
Device: Use of Telehealth equipment (Viterian V-100)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: VISN 23 COPD Case Management Using Home Telehealth Equipment

Resource links provided by NLM:


Further study details as provided by VA Nebraska Western Iowa Health Care System:

Primary Outcome Measures:
  • Patient compliance with utilizing home telehealth monitoring equipment in the two patient groups [ Time Frame: six months ] [ Designated as safety issue: No ]
  • The amount of Home telehealth case management time utilized to provide patient monitoring in the two patient groups [ Time Frame: six months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Evaluate patient ease of using the home telehealth equipment in the two patient groups. [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Patient satisfaction in managing their disease in the two patient groups [ Time Frame: six months ] [ Designated as safety issue: No ]
  • The number of COPD exacerbations, urgent care visits, and hospitalizations related to COPD in the two patient groups [ Time Frame: six months ] [ Designated as safety issue: No ]
  • Correlate the effect of oxygen saturation monitoring on the early identification of COPD exacerbations [ Time Frame: six months ] [ Designated as safety issue: No ]

Estimated Enrollment: 50
Study Start Date: March 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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.

  Eligibility

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

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
  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: NCT00916799

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

Publications:
Responsible Party: Naresh A. Dewan, M.D., VA Nebraska Western Iowa Heathcare System, Omaha
ClinicalTrials.gov Identifier: NCT00916799     History of Changes
Other Study ID Numbers: 00576
Study First Received: June 9, 2009
Last Updated: June 10, 2009
Health Authority: United States: Federal Government

Keywords provided by VA Nebraska Western Iowa Health Care System:
telehealth
oximetry
copd

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 22, 2014