Empowering Elders Through Technology

Congestive Heart Failure Clinical Trial

Official title:

Empowering Elders Through Technology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00261664
• Other study ID #: 49150
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: December 2, 2005
• Last updated: July 25, 2011
• Start date: September 2003
• Est. completion date: July 2005

Study information

• Verified date: July 2011
• Source: Robert Wood Johnson Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Telehomecare is a technology that individuals use in their homes to communicate with health providers electronically. This technology can help them function at a higher level and avoid undesirable hospitalizations by making changes in their everyday behaviors, but research is needed to understand how telehomecare supports health behavior change and leads to improved health status.

The hypothesis being tested is that the use of an electronic method of monitoring and transmitting health information facilitates patient empowerment, with subsequent effects on the patient's ability to manage her/his treatment regimen more effectively. The study will explore the relationship between telehomecare and acquisition of knowledge, and will show whether changes in knowledge levels translate to changes in behaviors and improved health outcomes. The effects of two different telehomecare systems (nurse-directed vs. patient-directed) on knowledge, self-management, and health status will be compared. A further goal is to illuminate the attitudes of physicians regarding the use of telehomecare in the treatment of their elderly, community dwelling patients.

Results will inform managers and policymakers who are responsible for integrating eHealth mechanisms into chronic disease protocols, funding health care programs, and creating policies that support the use of information technology by all Americans.

Description:

This study, funded by the Robert Wood Johnson Foundation through its Health e-Technologies Initiative (www.hetinitiative.org) is investigating the impact of telehomecare on health outcomes of persons with heart failure. The study began on September 1, 2003 and ends on February 28, 2006.

This study targets elderly persons with congestive heart failure (CHF), a major health problem affecting more than 4 million Americans. The research hypothesis being tested is that the use of an electronic method of monitoring and transmitting health information facilitates patient empowerment, with subsequent effects on the patient's ability to manage her/his treatment regimen more effectively. The study will explore the linkages between telehomecare and acquisition of knowledge, and will show whether changes in knowledge levels translate to changes in behaviors and improved health outcomes.

The effects of two different telehomecare systems (nurse-directed vs. patient-directed) on knowledge, self-management, and health status will be compared. A further goal is to illuminate the attitudes of physicians regarding the use of telehomecare in the treatment of their elderly, community dwelling patients.

Specific objectives are:

1. To evaluate the impact of telehomecare on patients' knowledge and self-management of heart failure, and cardiovascular health outcomes;

2. To compare the effect of two different telehomecare systems on patients' knowledge and self-management of heart failure, and cardiovascular health outcomes;

3. To investigate how the personal characteristics of older persons influence human-computer interaction and user satisfaction;

4. To describe and predict the attitudes and intentions of physicians regarding the use of telehomecare applications; and,

5. To analyze relationships among individual characteristics, information use, self-management of heart-failure and health status.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: July 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• clinical diagnosis of congestive heart failure

• must have telephone line in home

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Congestive Heart Failure
• Heart Failure

Intervention

Device:
• telehomecare

Locations

Country	Name	City	State
United States	Pennsylvania State University	University Park	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Robert Wood Johnson Foundation	University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Self-management of heart failure