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

Primary Purpose

Heart Failure

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Health Guide using AHA heart failure protocols and content
Sponsored by
American Heart Association
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, congestive heart failure, telemedicine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospitals Home Care Services

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Health Guide using AHA protocols

Arm Description

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.

Outcomes

Primary Outcome Measures

Percentage of Days Participants Measured Vitals and Completed Protocol Sessions
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.
Percentage of Health Sessions That Patients Measured and Recorded Vitals
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.

Secondary Outcome Measures

Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change
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.
Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change
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.

Full Information

First Posted
January 12, 2011
Last Updated
March 6, 2022
Sponsor
American Heart Association
Collaborators
Intel Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01275846
Brief Title
Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
January 2011 (Actual)
Study Completion Date
March 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American Heart Association
Collaborators
Intel Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
heart failure, congestive heart failure, telemedicine

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
26 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Health Guide using AHA protocols
Arm Type
Experimental
Arm Description
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
Intervention Name(s)
Health Guide using AHA heart failure protocols and content
Other Intervention Name(s)
Intel Health Guide
Intervention Description
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 Outcome Measure Information:
Title
Percentage of Days Participants Measured Vitals and Completed Protocol Sessions
Description
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.
Time Frame
60 days
Title
Percentage of Health Sessions That Patients Measured and Recorded Vitals
Description
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.
Time Frame
60 days
Secondary Outcome Measure Information:
Title
Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change
Description
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.
Time Frame
Baseline is taken at the beginning of the study, 2nd is at 30 days and 3rd is at 60 days.
Title
Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change
Description
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.
Time Frame
Baseline is at the beginning of study, 2nd is at 30 days and 3rd is at 60 days.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George E Kikano, MD, CPE
Organizational Affiliation
Chair, Dept. of Family Medicine, Case Western Reserve University/University Hospitals
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ileana L Piña, MD, MPH
Organizational Affiliation
Professor, Medicine & Epi/Biostats, Case Western Reserve University/University Hospitals
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospitals Home Care Services
City
Warrensville Heights
State/Province
Ohio
ZIP/Postal Code
44128
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.heart.org
Description
The American Heart Association's mission is to build healthier lives, free of cardiovascular diseases and stroke.

Learn more about this trial

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

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