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

NCT ID: NCT01275846

Last Updated: 2022-03-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2011-03-31

Brief 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.

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

Conditions

Heart Failure

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Health Guide using AHA heart failure protocols and content

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Intel Health Guide

Eligibility 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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intel Corporation

INDUSTRY

Sponsor Role: collaborator

American Heart Association

OTHER

Sponsor Role: lead

Responsible Party

Ileana L. Piña

Professor of Medicine & Epidemiology and Population Health, Albert Einstein College of Medicine, Montefiore Medical Center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George E Kikano, MD, CPE

Role: PRINCIPAL_INVESTIGATOR

Chair, Dept. of Family Medicine, Case Western Reserve University/University Hospitals

Ileana L Piña, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Professor, Medicine & Epi/Biostats, Case Western Reserve University/University Hospitals

Locations

University Hospitals Home Care Services

Warrensville Heights, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

http://www.heart.org

The American Heart Association's mission is to build healthier lives, free of cardiovascular diseases and stroke.

Other Identifiers

RES116137

Identifier Type: OTHER

Identifier Source: secondary_id

AHA100602

Identifier Type: -

Identifier Source: org_study_id