NCT00916799

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2009

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 10, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

8 months

First QC Date

June 9, 2009

Last Update Submit

June 10, 2009

Conditions

COPD

Keywords

telehealthoximetrycopd

Outcome Measures

Primary Outcomes (2)

  • 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 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

    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

Study Arms (1)

Oximeter arm and non-oximetry arm

EXPERIMENTAL
Device: Use of Telehealth equipment (Viterian V-100)

Interventions

Use of Telehealth equipment (Viterian V-100)DEVICE

Patient will daily enter answers to questions generated from a home telehealth monitor

Also known as: Viterian V-100
Oximeter arm and non-oximetry arm

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Medical Center, Minneapolis

Minneapolis, Minnesota, 55417, United States

NOT YET RECRUITING

VA Nebraska Western Iowa Healthcare System, Omaha

Omaha, Nebraska, 68105, United States

RECRUITING

Related Publications (3)

  • 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.

    PMID: 15319047RESULT

  • 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.

    PMID: 16036007RESULT

  • 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.

    PMID: 18023610RESULT

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Naresh A Dewan, M.D.

    VA Nebraska Western Iowa Healthcare System, Omaha

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
FED

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 10, 2009

Study Start

March 1, 2009

Primary Completion

November 1, 2009

Study Completion

May 1, 2010

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

US(2)