An Evaluation of Home-Based Telemedicine Services
Primary Purpose
Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Home care telemedicine
Sponsored by
About this trial
This is an interventional treatment trial for Congestive Heart Failure
Eligibility Criteria
Inclusion Criteria: Patients must be enrolled in the home care program at the Indianapolis VAMC and have at least: (a) 6 outpatient visits, one hospitalization, or 2 or more emergency room visits in the last twelve months, (b) a care plan specifying two or more skilled nursing visits per month, (c) an expected need for future home care visits for at least one month. Exclusion Criteria:
Sites / Locations
- VA Ann Arbor Healthcare System, Ann Arbor, MI
- Richard L. Roudebush VA Medical Center, Indianapolis, IN
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Arm 1
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00105846
First Posted
March 17, 2005
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
1. Study Identification
Unique Protocol Identification Number
NCT00105846
Brief Title
An Evaluation of Home-Based Telemedicine Services
Official Title
An Evaluation of Home-Based Telemedicine Services
Study Type
Interventional
2. Study Status
Record Verification Date
February 2007
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2004 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.
Detailed Description
Background:
Tele-home health care, which providers for video interactions between home-based veterans and home care nurses, is a potentially useful adjunct to home care services. However, few randomized trials have been conducted of this technology.
Objectives:
The primary objectives were to determine if tele-home health care patients, compared with patients receiving usual home care, have:1) higher levels of health related quality of life and home care satisfaction; 2) fewer inpatient admissions, hospital stays, and outpatient and emergency room visits; and 3) higher levels of home care access, in terms of the total number of contacts between HBPC nurses and patients.
Methods:
Patients were randomly assigned to the intervention or to the control group. Video tele-health units were installed in patient homes for the intervention group, and control group patients received usual home care services. Baseline and six month follow up surveys included questions on perceived health related quality of life and home care satisfaction. T-tests were used to compare intervention and control group members in terms of six month changes in health related quality of life and satisfaction with home care. Multivariate analyses were used to assess group differences in six month health care service use, with prior service use and survival included as covariates.
Status:
The study is completed, with a final enrollment of 37 patients. Three study manuscrip[ts have been completed (two published and one under review).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congestive Heart Failure, Chronic Obstructive Pulmonary Disease, Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Home care telemedicine
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patients must be enrolled in the home care program at the Indianapolis VAMC and have at least: (a) 6 outpatient visits, one hospitalization, or 2 or more emergency room visits in the last twelve months, (b) a care plan specifying two or more skilled nursing visits per month, (c) an expected need for future home care visits for at least one month.
Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Faith P. Hopp, PhD MA MSW
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States
Facility Name
Richard L. Roudebush VA Medical Center, Indianapolis, IN
City
Indianapolis
State/Province
Nebraska
ZIP/Postal Code
46202-2884
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
16796497
Citation
Hopp F, Woodbridge P, Subramanian U, Copeland L, Smith D, Lowery J. Outcomes associated with a home care telehealth intervention. Telemed J E Health. 2006 Jun;12(3):297-307. doi: 10.1089/tmj.2006.12.297.
Results Reference
result
PubMed Identifier
15319045
Citation
Subramanian U, Hopp F, Lowery J, Woodbridge P, Smith D. Research in home-care telemedicine: challenges in patient recruitment. Telemed J E Health. 2004 Summer;10(2):155-61. doi: 10.1089/tmj.2004.10.155.
Results Reference
result
Citation
Hopp F, Woodbridge P, Subramanian U, Copeland L, Smith D. Home telehealth's role in diabetes case management. Telemedicine journal and e-health : the official journal of the American Telemedicine Association. 2005 Apr 1; 11:220.
Results Reference
result
Learn more about this trial
An Evaluation of Home-Based Telemedicine Services
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