Heart Failure
Conditions
Keywords
heart failure, congestive heart failure, telemedicine
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
Interventions
DEVICEHealth 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.
Sponsors
Intel Corporation
American Heart Association
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Days Participants Measured Vitals and Completed Protocol Sessions | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
Countries
United States
Participant flow
Recruitment details
The University Hospitals Home Care Services program, which is nurse driven for patients within a certain radius from the hospital, was the source of patient referral. Patients were self-selected and consented following hospital discharge with a heart failure diagnosis, were home bound, thus qualified for the home care nursing program.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| Total | 26 |
Baseline characteristics
| Characteristic | Health Guide Using AHA Protocols |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 22 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants |
| Age, Continuous | 75 years STANDARD_DEVIATION 10 |
| Region of Enrollment United States | 26 Participants |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 26 |
| other Total, other adverse events | 0 / 26 |
| serious Total, serious adverse events | 13 / 26 |
Outcome results
Primary
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.
Time frame: 60 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Health Guide Using AHA Protocols | Percentage of Days Participants Measured Vitals and Completed Protocol Sessions | 88 percentage of days |
Primary
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.
Time frame: 60 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Health Guide Using AHA Protocols | Percentage of Health Sessions That Patients Measured and Recorded Vitals | 77 percentage of health sessions completed |
Secondary
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.
Time frame: Baseline is taken at the beginning of the study, 2nd is at 30 days and 3rd is at 60 days.
Population: The scale is from 0 to 100; 100 being the best quality of life. A change of 5 points or higher is clinically significant. The first five items (physical limitation, symptom stability, symptom frequency, total symptom score) are combined with the quality of life domain to get the clinical score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Guide Using AHA Protocols | Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change | Baseline | 50.74 score on a scale | Standard Deviation 22.89 |
| Health Guide Using AHA Protocols | Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change | Second | 51.69 score on a scale | Standard Deviation 22.95 |
| Health Guide Using AHA Protocols | Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Clinical Summary Score Change | Third | 65.36 score on a scale | Standard Deviation 22.06 |
Secondary
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.
Time frame: Baseline is at the beginning of study, 2nd is at 30 days and 3rd is at 60 days.
Population: The scale is from 0 to 100; 100 being the best quality of life. A change of 5 points or higher is clinically significant. The first five items (physical limitation, symptom stability, symptom frequency, total symptom score) are combined with the quality of life domain to get the clinical score.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Health Guide Using AHA Protocols | Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change | Baseline | 48.74 score on a scale | Standard Deviation 25.06 |
| Health Guide Using AHA Protocols | Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change | Second | 49.84 score on a scale | Standard Deviation 25.18 |
| Health Guide Using AHA Protocols | Patient Quality of Life Using the Kansas City Cardiomyopathy Questionnaire (KCCQ) Mean Overall Score Change | Third | 63.38 score on a scale | Standard Deviation 26.28 |