Clinical trial NCT00916799: VISN 23 Chronic Obstructive Pulmonary Disease (COPD) Case Management Using Home Telehealth Equipment
Official title: VISN 23 COPD Case Management Using Home Telehealth Equipment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Keywords: telehealth
oximetry
copd
Lead sponsor: VA Nebraska Western Iowa Health Care System
Sponsor class: FED
First posted: 2009-06-10
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP

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.

Eligibility 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

Primary outcomes:
measure: Patient compliance with utilizing home telehealth monitoring equipment in the two patient groups
timeFrame: six months
measure: The amount of Home telehealth case management time utilized to provide patient monitoring in the two patient groups
timeFrame: six months
Secondary outcomes:
measure: 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
timeFrame: six months
measure: Evaluate patient ease of using the home telehealth equipment in the two patient groups.
timeFrame: six months
measure: Patient satisfaction in managing their disease in the two patient groups
timeFrame: six months
measure: The number of COPD exacerbations, urgent care visits, and hospitalizations related to COPD in the two patient groups
timeFrame: six months
measure: Correlate the effect of oxygen saturation monitoring on the early identification of COPD exacerbations
timeFrame: six months
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: VA Medical Center, Minneapolis
state: Minnesota
city: Omaha
country: United States
facility: VA Nebraska Western Iowa Healthcare System, Omaha
state: Nebraska
Study officials:
affiliation: VA Nebraska Western Iowa Healthcare System, Omaha
name: Naresh A Dewan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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 follow-up. J Telemed Telecare. 2005;11 Suppl 1:86-8. doi: 10.1258/1357633054461697.
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. doi: 10.1016/j.ijmedinf.2007.10.006. Epub 2007 Nov 26.