Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure

Heart Failure Clinical Trial

Official title:

Evaluating Telehealth Home Care for Elderly Veterans With Congestive Heart Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00057200
• Other study ID #: NRI 99-345
• Status: Completed
• Phase: N/A
• First received: March 27, 2003
• Last updated: April 6, 2015
• Est. completion date: January 2005

Study information

• Verified date: February 2007
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: January 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Heart Failure
• Telemedicine

Intervention

Procedure:
• Telephone, videophone care

Locations

Country	Name	City	State
United States	Iowa City VA Health Care System, Iowa City, IA	Iowa City	Iowa

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (7)

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 chroni — View 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. — View 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.

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. — View 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. — View 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. — View 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. — View Citation