Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System
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
2 other identifiers
interventional
26
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable heart-failure
Started Jun 2010
Shorter than P25 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedFirst Submitted
Initial submission to the registry
January 12, 2011
CompletedFirst Posted
Study publicly available on registry
January 13, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedResults Posted
Study results publicly available
March 31, 2022
CompletedMarch 31, 2022
March 1, 2022
7 months
January 12, 2011
July 8, 2019
March 6, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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.
60 days
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.
60 days
Secondary Outcomes (2)
Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) 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
Baseline is at the beginning of study, 2nd is at 30 days and 3rd is at 60 days.
Study Arms (1)
Health Guide using AHA protocols
EXPERIMENTALParticipants 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
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- American Heart Associationlead
- Intel Corporationcollaborator
Study Sites (1)
University Hospitals Home Care Services
Warrensville Heights, Ohio, 44128, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Limitations of this study due to funding limitations included: very small patient sample size (26) from a single center enrollment in Northeast Ohio, with a short monitoring period (60 days), non-randomized and with no control group.
Results Point of Contact
- Title
- Ileana L. Piña, MD, MPH, FAHA, FACC
- Organization
- Detroit Medical Center, Detroit, MI
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine & Epidemiology and Population Health, Albert Einstein College of Medicine, Montefiore Medical Center
Study Record Dates
First Submitted
January 12, 2011
First Posted
January 13, 2011
Study Start
June 1, 2010
Primary Completion
January 1, 2011
Study Completion
March 1, 2011
Last Updated
March 31, 2022
Results First Posted
March 31, 2022
Record last verified: 2022-03