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

March 6, 2022 updated by: Ileana L. Piña, American Heart Association

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • Intel Health Guide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Days Participants Measured Vitals and Completed Protocol Sessions
Time Frame: 60 days
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. Utility was defined as days of activity and interaction of the patient with the monitor / days of actual monitoring possible.
60 days
Percentage of Health Sessions That Patients Measured and Recorded Vitals
Time Frame: 60 days
Measuring the percentage of available health sessions that the patient measures and records his/her vitals (weight, blood pressure, blood oxygen saturation level, glucose level) and during the monitoring period. Adherence (or patient compliance) was defined as the percent of actual completed sessions from the number of scheduled sessions offered.
60 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change
Time Frame: Baseline is taken at the beginning of the study, 2nd is at 30 days and 3rd is at 60 days.
Impact of the Intel® Health Guide System using AHA heart failure protocols and educational content on the patient's quality of life as measured pre and post intervention (mean clinical summary score change) using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item self-administered questionnaire used to measure the patient's perception of their health status. The KCCQ tool quantifies six (6) distinct domains (symptom, physical function, quality of life, social limitation, self-efficacy and symptom stability) and two (2) summary scores (clinical and overall). This measure represents the Mean Clinical Summary Score Change.
Baseline is taken at the beginning of the study, 2nd is at 30 days and 3rd is at 60 days.
Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change
Time Frame: Baseline is at the beginning of study, 2nd is at 30 days and 3rd is at 60 days.
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 (mean overall score change) using the Kansas City Cardiomyopathy Questionnaire (KCCQ). The KCCQ is a 23-item self-administered questionnaire used to measure the patient's perception of their health status. The KCCQ tool quantifies six (6) distinct domains (symptom, physical function, quality of life, social limitation, self-efficacy and symptom stability) and two (2) summary scores (clinical and overall). This measure represents the Mean Overall Score Change.
Baseline is at the beginning of study, 2nd is at 30 days and 3rd is at 60 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

American Heart Association

Collaborators

Intel Corporation

Investigators

  • Principal Investigator: George E Kikano, MD, CPE, Chair, Dept. of Family Medicine, Case Western Reserve University/University Hospitals
  • Principal Investigator: Ileana L Piña, MD, MPH, Professor, Medicine & Epi/Biostats, Case Western Reserve University/University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (ACTUAL)

January 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

January 12, 2011

First Submitted That Met QC Criteria

January 12, 2011

First Posted (ESTIMATE)

January 13, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 31, 2022

Last Update Submitted That Met QC Criteria

March 6, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AHA100602
  • RES116137 (OTHER: Case Western Reserve University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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