Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System - Full Text View

Purpose

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.

Condition	Intervention
Heart Failure	Device: Health Guide using AHA heart failure protocols and content

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care
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

Resource links provided by NLM:

MedlinePlus related topics: Heart Failure

U.S. FDA Resources

Further study details as provided by American Heart Association:

Primary Outcome Measures:

Vitals tracking and protocol session adherence [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Measuring the percentage of available days the patient measures and records his/her vitals (weight, blood pressure, blood oxygen saturation level, glucose level) and completes his/her protocol sessions during the monitoring period.
Notification types, frequency, and intervention summary [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Measure the quantity, types, and trend of notifications during the monitoring period and summarize the actions(s) that were taken by the clinician at the time of each patient notification.

Secondary Outcome Measures:

Intel® Health Guide System patient and clinician satisfaction scores [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Measuring the patient's and clinician's satisfaction using the Intel® Health Guide with AHA heart failure protocols and educational content.
Patient Quality of Life using the Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Impact of the Intel® Health Guide System using AHA heart failure protocols and educational content on the patient's quality of life measured pre and post intervention.
Knowledge and Illness Beliefs about Heart Failure [ Time Frame: 60 days ] [ Designated as safety issue: No ]
Impact of the Intel® Health Guide System using AHA heart failure protocols and educational content on the patient's understanding and beliefs about their condition measured pre and post intervention.

Enrollment:	26
Study Start Date:	June 2010
Estimated Study Completion Date:	March 2011
Estimated Primary Completion Date:	January 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Health Guide using AHA protocols 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.	Device: Health Guide using AHA heart failure protocols and content 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. Other Name: Intel Health Guide

Arms

Assigned Interventions

Experimental: Health Guide using AHA protocols

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.

Device: Health Guide using AHA heart failure protocols and content

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.

Other Name: Intel Health Guide

Detailed 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

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01275846

Locations

United States, Ohio
University Hospitals Home Care Services
Warrensville Heights, Ohio, United States, 44128

Sponsors and Collaborators

American Heart Association

Intel

Investigators

Principal Investigator:	George E Kikano, MD, CPE	Dorothy Jones Weatherhead Professor of Medicine Professor and Chair, Department of Family Medicine, Case Western Reserve University/University Hospitals
Principal Investigator:	Ileana L Piña, MD, MPH	Professor of Medicine and Epi/Biostats, Case Western Reserve University/University Hospitals

More Information

Additional Information:

The American Heart Association's mission is to build healthier lives, free of cardiovascular diseases and stroke. This link exits the ClinicalTrials.gov site

This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	George E. Kikano, MD, CPE, FAAFP, Dorothy Jones Weatherhead Professor of Medicine Professor and Chair, Department of Family Medicine, Case Western Reserve University/University Hospitals
ClinicalTrials.gov Identifier:	NCT01275846 History of Changes
Other Study ID Numbers:	AHA100602, RES116137
Study First Received:	January 12, 2011
Last Updated:	January 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by American Heart Association:

heart failure
congestive heart failure
telemedicine

Additional relevant MeSH terms:

Heart Failure
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 21, 2013