Heart FailureNCT01275846
Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System
A study testing Health Guide using AHA heart failure protocols and content in people with Heart Failure, run by American Heart Association at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Heart Failure
- What is being tested?
- Health Guide using AHA heart failure protocols and content
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Home Care Services
Warrensville Heights, Ohio, 44128
About this study
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
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.
Read the 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
- Being tested
- Health Guide using AHA heart failure protocols and content
- Keywords
- heart failure, congestive heart failure, telemedicine
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Guide using AHA heart failure protocols and contentDevice
Also called Intel Health Guide
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.
| Study group | Role | What they receive |
|---|---|---|
| Health Guide using AHA protocols | Experimental | 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. Receives: Device: Health Guide using AHA heart failure protocols and content |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 60 days
Secondary outcomes (2)
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.
Measured: 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
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.
Measured: Baseline is at the beginning of study, 2nd is at 30 days and 3rd is at 60 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2011 (estimated)
- Study startJun 2010
- Primary completionJan 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- American Heart Association
- Sponsor type
- University, hospital or other
- Collaborators
- Intel Corporation
- Responsible party
- Principal investigator, Ileana L. Piña, American Heart Association
- Investigators
- George E Kikano, MD, CPE, Principal investigator, Chair, Dept. of Family Medicine, Case Western Reserve University/University HospitalsIleana L Piña, MD, MPH, Principal investigator, Professor, Medicine & Epi/Biostats, Case Western Reserve University/University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01275846
- Sponsor's protocol ID
- AHA100602
- Other IDs
- RES116137
- Status last verified
- Mar 2022
- First submitted
- 12 Jan 2011
- Last updated
- 31 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01275846
- Acronym / sponsor ID
- AHA100602
- Conditions
- Heart Failure
- Keywords
- heart failure, congestive heart failure, telemedicine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- American Heart AssociationUniversity, hospital or other
- Collaborators
- Intel Corporation
- Study start
- Jun 2010
- Primary completion
- Jan 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Jan 2011 (estimated)
- Results
- Posted 31 Mar 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health Guide using AHA protocols | Experimental | Device: Health Guide using AHA heart failure protocols and contentParticipants 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Health Guide using AHA heart failure protocols and contentAlso: Intel Health GuideParticipants 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 protocols |
Primary outcome
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.
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.
2 secondary outcomes
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- The American Heart Association's mission is to build healthier lives, free of cardiovascular diseases and stroke.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George E Kikano, MD, CPE principal investigator
Chair, Dept. of Family Medicine, Case Western Reserve University/University Hospitals
Ileana L Piña, MD, MPH principal investigator
Professor, Medicine & Epi/Biostats, Case Western Reserve University/University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Guide using AHA heart failure protocols and content in people with Heart Failure, run by American Heart Association at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Mar 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Days Participants Measured Vitals and Completed Protocol Sessions (time frame: 60 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Mar 2022.