Clinical trial NCT01275846: 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
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: heart failure
congestive heart failure
telemedicine
Lead sponsor: American Heart Association
Sponsor class: OTHER
Collaborators: name: Intel Corporation
First posted: 2011-01-13
Enrollment: 26
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Percentage of Days Participants Measured Vitals and Completed Protocol Sessions
timeFrame: 60 days
measure: Percentage of Health Sessions That Patients Measured and Recorded Vitals
timeFrame: 60 days
Secondary outcomes:
measure: Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change
timeFrame: Baseline is taken at the beginning of the study, 2nd is at 30 days and 3rd is at 60 days.
measure: Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change
timeFrame: Baseline is at the beginning of study, 2nd is at 30 days and 3rd is at 60 days.
Other outcomes:
Locations:
city: Warrensville Heights
country: United States
facility: University Hospitals Home Care Services
state: Ohio
Study officials:
affiliation: Chair, Dept. of Family Medicine, Case Western Reserve University/University Hospitals
name: George E Kikano, MD, CPE
role: PRINCIPAL_INVESTIGATOR
affiliation: Professor, Medicine & Epi/Biostats, Case Western Reserve University/University Hospitals
name: Ileana L Piña, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: