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Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure

Primary Purpose

Heart Failure, Telemedicine

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Telephone, videophone care
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Failure focused on measuring Home Care

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients admitted to the Iowa City VA Medical Center for treatment of congestive heart failure exacerbation. Must be cognitively intact and have a telephone line in the home. Exclusion Criteria:

Sites / Locations

  • Iowa City VA Health Care System, Iowa City, IA

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 27, 2003
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00057200
Brief Title
Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure
Official Title
Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure
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
January 2005 (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
Congestive heart failure (CHF) is one of the most common reasons for hospitalization in patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable if the warning signs of decompensation are recognized and treated before the situation becomes emergent. Home-based intervention programs have reduced unplanned readmission rates for patients with CHF by up to 50 percent. Using advanced telecommunications technologies it is now possible to provide greatly improved access and availability of services in a more timely and cost effective manner directly to patients� homes. Although telehealth offers a number of theoretical advantages, few empirical studies have compared telehealth to traditional delivery modes, and virtually no studies have compared the effectiveness of alternative telehealth applications.
Detailed Description
Background: Congestive heart failure (CHF) is one of the most common reasons for hospitalization in patients aged 65 years and older. Many hospitalizations for CHF are potentially preventable if the warning signs of decompensation are recognized and treated before the situation becomes emergent. Home-based intervention programs have reduced unplanned readmission rates for patients with CHF by up to 50 percent. Using advanced telecommunications technologies it is now possible to provide greatly improved access and availability of services in a more timely and cost effective manner directly to patients� homes. Although telehealth offers a number of theoretical advantages, few empirical studies have compared telehealth to traditional delivery modes, and virtually no studies have compared the effectiveness of alternative telehealth applications. Objectives: The purpose of this study is to compare the effectiveness and resource use of two telehealth interventions to traditional care provided for recently discharged outpatients with CHF. Four hypotheses will be tested. Compared to subjects who receive usual care, subjects who receive telehealth interventions (telephone or interactive video) following discharge will: 1) have lower readmission rates; 2) report improved quality of life, self-efficacy, and satisfaction with care; 3) use fewer resources, including hospital days, urgent care visits, and telephone calls; and 4) have higher survival rates. Methods: The study is a randomized controlled clinical trial. We will compare usual care to an intervention delivered by either telephone or interactive video to veterans following discharge from the hospital. A total of 198 subjects will be enrolled over three years. Subjects in the treatment groups (telephone or interactive video) will receive the intervention for 90 days following discharge from the hospital. Data to be collected includes measures of quality of life, self-efficacy, satisfaction, resource use, and mortality. Status: Project work is ongoing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Telemedicine
Keywords
Home Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Telephone, videophone care

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients admitted to the Iowa City VA Medical Center for treatment of congestive heart failure exacerbation. Must be cognitively intact and have a telephone line in the home. Exclusion Criteria:
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bonnie J. Wakefield, PhD RN
Organizational Affiliation
Iowa City VA Health Care System, Iowa City, IA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Iowa City VA Health Care System, Iowa City, IA
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52246-2208
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18649820
Citation
Wakefield BJ, Orris LJ, Holman JE, Russell CL. User perceptions of in-home medication dispensing devices. J Gerontol Nurs. 2008 Jul;34(7):15-25. doi: 10.3928/00989134-20080701-10.
Results Reference
result
PubMed Identifier
18337049
Citation
Wakefield BJ, Bylund CL, Holman JE, Ray A, Scherubel M, Kienzle MG, Rosenthal GE. Nurse and patient communication profiles in a home-based telehealth intervention for heart failure management. Patient Educ Couns. 2008 May;71(2):285-92. doi: 10.1016/j.pec.2008.01.006. Epub 2008 Mar 11.
Results Reference
result
PubMed Identifier
18954244
Citation
Wakefield BJ, Ward MM, Holman JE, Ray A, Scherubel M, Burns TL, Kienzle MG, Rosenthal GE. Evaluation of home telehealth following hospitalization for heart failure: a randomized trial. Telemed J E Health. 2008 Oct;14(8):753-61. doi: 10.1089/tmj.2007.0131.
Results Reference
result
PubMed Identifier
19139220
Citation
Wakefield BJ, Holman JE, Ray A, Scherubel M, Burns TL, Kienzle MG, Rosenthal GE. Outcomes of a home telehealth intervention for patients with heart failure. J Telemed Telecare. 2009;15(1):46-50. doi: 10.1258/jtt.2008.080701.
Results Reference
result
PubMed Identifier
19119835
Citation
Darkins A, Ryan P, Kobb R, Foster L, Edmonson E, Wakefield B, Lancaster AE. Care Coordination/Home Telehealth: the systematic implementation of health informatics, home telehealth, and disease management to support the care of veteran patients with chronic conditions. Telemed J E Health. 2008 Dec;14(10):1118-26. doi: 10.1089/tmj.2008.0021.
Results Reference
result
Citation
Wakefield BJ, Holman JE, Ray A, Morse J, Kiensie M. Nurse and patient preferences for telehealth home care. Geriatric Times. 2004 Mar 1; V(2):27-30.
Results Reference
result
PubMed Identifier
15165441
Citation
Wakefield BJ, Holman JE, Ray A, Morse J, Kienzle MG. Nurse and patient communication via low- and high-bandwidth home telecare systems. J Telemed Telecare. 2004;10(3):156-9. doi: 10.1258/135763304323070805.
Results Reference
result

Learn more about this trial

Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure

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