VISN 23 Chronic Obstructive Pulmonary Disease (COPD) Case Management Using Home Telehealth Equipment
Recruitment status was Recruiting
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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 |
- 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 ]
- 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 |
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| 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. | |
| 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 May 19, 2013