Overview

This trial is active, not recruiting.

Condition heart failure
Treatment health guide using aha heart failure protocols and content
Sponsor American Heart Association
Collaborator Intel Corporation
Start date June 2010
End date January 2011
Trial size 26 participants
Trial identifier NCT01275846, AHA100602, RES116137

Summary

This purposed of this study is to ascertain if the implementation of remote patient management systems utilizing American Heart Association (AHA) guideline-based heart failure protocols and educational content can improve the management of patients with congestive heart failure.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
Participants in the study will receive the use of the Intel Health Guide, a telehealth device, with AHA customized heart failure protocols, response algorithms and educational content. Participants interact with the Intel Health Guide device, receiving immediate feedback when transmitting vitals measures and health question responses to a site monitored by their nurse case managers. Nurse case managers review and address concerns raised in vitals and/or question responses through standard care protocols established by their institution. Nurse case managers strive to enhance the participants quality of life, support continuity of care, facilitate provision of services in the appropriate setting to promote positive health outcomes.
health guide using aha heart failure protocols and content Intel Health Guide
Participants in the study will receive the use of the Intel Health Guide, a telehealth device, with AHA customized heart failure protocols, response algorithms and educational content. Participants interact with the Intel Health Guide device, receiving immediate feedback when transmitting vitals measures and health question responses to a site monitored by their nurse case managers. Nurse case managers review and address concerns raised in vitals and/or question responses through standard care protocols established by their institution. Nurse case managers strive to enhance the participants quality of life, support continuity of care, facilitate provision of services in the appropriate setting to promote positive health outcomes.

Primary Outcomes

Measure
Vitals tracking and protocol session adherence
time frame: 60 days
Notification types, frequency, and intervention summary
time frame: 60 days

Secondary Outcomes

Measure
Intel® Health Guide System patient and clinician satisfaction scores
time frame: 60 days
Patient Quality of Life using the Kansas City Cardiomyopathy Questionnaire (KCCQ)
time frame: 60 days
Knowledge and Illness Beliefs about Heart Failure
time frame: 60 days

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: - Patient has a diagnosis of Heart Failure NYHA and is currently in functional class II- IV status. - Patient has been hospitalized for an episode of acute HF decompensation within the last 30 days. - Patients with other co-morbidities such as atrial fibrillation, diabetes, coronary artery disease, COPD, hypertension, may be included in this evaluation. These conditions shall be documented during enrollment. - Have telephone line or broadband internet availability to connect Intel® Health Guide. - Are physically and mentally capable to complete the monitoring process or have a caregiver capable of assisting in the use of the Intel® Health Guide. - Will be willing and able to sign an informed consent form to participate in this evaluation for a duration of 60 days. - Live within a reasonable distance (30 miles or less) from the institution. Exclusion Criteria: - Have a life expectancy of less than six months. - Live in a nursing home or other multi-member assisted living facility. - Intend to be away from their home for more than 2 weeks (14 days) total during the 60 days. - Are unable to read English at a minimum 5th grade level. - Do not live within a reasonable distance (30 miles or less) from the institution.

Additional Information

Official title Study for Deployment of American Heart Association Heart Failure Protocols and Educational Content Within the Intel® Health Guide System With a Congestive Heart Failure Cohort
Principal investigator George E Kikano, MD, CPE
Description This prospective, comparative study uses a pre-post test design to ascertain if the implementation of remote patient management systems utilizing AHA guideline-based heart failure protocols and educational content can successfully address the following objectives: - validate the suitability of the Intel Health Guide to deploy AHA guideline-based patient care protocols and health content to patients managing congestive heart failure - confirm that the AHA protocols as deployed on the HGS are supportive for clinicians following the AHA guidelines in a telehealth environment - validate and verify that the data intended to be collected was effectively collected - measure patient and provider satisfaction with use of the system
Trial information was received from ClinicalTrials.gov and was last updated in January 2011.
Information provided to ClinicalTrials.gov by American Heart Association.