COPDNCT00916799
VISN 23 Chronic Obstructive Pulmonary Disease (COPD) Case Management Using Home Telehealth Equipment
A study testing Use of Telehealth equipment (Viterian V-100) in people with COPD, run by US Department of Veterans Affairs at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD
- What is being tested?
- Use of Telehealth equipment (Viterian V-100)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Not yet recruiting
VA Medical Center, Minneapolis
Minneapolis, Minnesota, 55417
Kathryn Rice, M.D., 612-467-4400, Kathryn.rice@va.gov
Mary Dahlheimer, RN, 612 467-4400, mary.dahlheimer@va.gov
- Recruiting
VA Nebraska Western Iowa Healthcare System, Omaha
Omaha, Nebraska, 68105
Naresh A Dewan, M.D., 402-346-8800 ext. 4039, naresh.dewan@va.gov
Michael C Caldwell, RN, RRT, 402 346-8800 ext. 3312, michael.caldwell@va.gov
About this study
Official title: 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.
Read the 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.
- Conditions
- COPD
- Being tested
- Use of Telehealth equipment (Viterian V-100)
- Keywords
- telehealth, oximetry, copd
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of Telehealth equipment (Viterian V-100)Device
Also called Viterian V-100
Patient will daily enter answers to questions generated from a home telehealth monitor
| Study group | Role | What they receive |
|---|---|---|
| Oximeter arm and non-oximetry arm | Experimental | Not described Receives: Device: Use of Telehealth equipment (Viterian V-100) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient compliance with utilizing home telehealth monitoring equipment in the two patient groups
Measured: six months
The amount of Home telehealth case management time utilized to provide patient monitoring in the two patient groups
Measured: six months
Secondary outcomes (5)
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
Measured: six months
Evaluate patient ease of using the home telehealth equipment in the two patient groups.
Measured: six months
Patient satisfaction in managing their disease in the two patient groups
Measured: six months
The number of COPD exacerbations, urgent care visits, and hospitalizations related to COPD in the two patient groups
Measured: six months
Correlate the effect of oxygen saturation monitoring on the early identification of COPD exacerbations
Measured: six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startMar 2009
- Primary completionNov 2009 (estimated)
- Study completionMay 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Naresh A Dewan, M.D., Principal investigator, VA Nebraska Western Iowa Healthcare System, Omaha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00916799
- Sponsor's protocol ID
- 00576
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 15319047Vontetsianos 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.
PubMed 16036007Rahimpour 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.
PubMed 18023610
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VISN 23 COPD Case Management Using Home Telehealth Equipment
- ClinicalTrials.gov ID
- NCT00916799
- Acronym / sponsor ID
- 00576
- Conditions
- COPD
- Keywords
- telehealth, oximetry, copd
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Mar 2009
- Primary completion
- Nov 2009 (estimated)
- Study completion
- May 2010 (estimated)
- First posted
- 10 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oximeter arm and non-oximetry arm | Experimental | Device: Use of Telehealth equipment (Viterian V-100) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of Telehealth equipment (Viterian V-100)Also: Viterian V-100Patient will daily enter answers to questions generated from a home telehealth monitor | Device | Oximeter arm and non-oximetry arm |
Primary outcome
Patient compliance with utilizing home telehealth monitoring equipment in the two patient groups
Time frame: six months
The amount of Home telehealth case management time utilized to provide patient monitoring in the two patient groups
Time frame: six months
5 secondary outcomes
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
Evaluate patient ease of using the home telehealth equipment in the two patient groups.
Time frame: six months
Patient satisfaction in managing their disease in the two patient groups
Time frame: six months
The number of COPD exacerbations, urgent care visits, and hospitalizations related to COPD in the two patient groups
Time frame: six months
Correlate the effect of oxygen saturation monitoring on the early identification of COPD exacerbations
Time frame: six months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2009.
- Results publication: PubMed 15319047Noel 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.
- Results publication: PubMed 16036007Vontetsianos 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.
- Results publication: PubMed 18023610Rahimpour 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
VA Nebraska Western Iowa Healthcare System, Omaha
Omaha, United States
Naresh A Dewan, M.D. principal investigator
VA Nebraska Western Iowa Healthcare System, Omaha
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of Telehealth equipment (Viterian V-100) in people with COPD, run by US Department of Veterans Affairs at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient compliance with utilizing home telehealth monitoring equipment in the two patient groups (time frame: six months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00916799, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2009.