Trial Outcomes & Findings for Deployment of American Heart Association Heart Failure Protocols and Content Within the Intel® Health Guide System (NCT NCT01275846)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

26 participants

Primary outcome timeframe

60 days

Results posted on

2022-03-31

Participant Flow

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.

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	26
Overall Study COMPLETED	25
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Health Guide Using AHA Protocols n=26 Participants 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	4 Participants n=5 Participants
Age, Categorical >=65 years	22 Participants n=5 Participants
Age, Continuous	75 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	10 Participants n=5 Participants
Region of Enrollment United States	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Guide Using AHA Protocols n=26 Participants 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.
Percentage of Days Participants Measured Vitals and Completed Protocol Sessions	88 percentage of days Interval 82.2 to 96.9

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Health Guide Using AHA Protocols n=26 Participants 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.
Percentage of Health Sessions That Patients Measured and Recorded Vitals	77 percentage of health sessions completed Interval 67.4 to 97.2

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Health Guide Using AHA Protocols n=26 Participants 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.
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Health Guide Using AHA Protocols n=26 Participants 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.
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
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
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

Adverse Events

Health Guide Using AHA Protocols

Serious events: 13 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Health Guide Using AHA Protocols n=26 participants at risk 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.
Cardiac disorders Rehospitalization	15.4% 4/26 • Number of events 4 • 60 days from consent and enrollment
General disorders Rehospitalization	34.6% 9/26 • Number of events 9 • 60 days from consent and enrollment

Other adverse events

Adverse event data not reported

Additional Information

Ileana L. Piña, MD, MPH, FAHA, FACC

Detroit Medical Center, Detroit, MI

Phone: 216-225-7385

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place