Heart Failure Patients Clinical Trial
Official title:
Monitoring and Self-management of Sleep Fatigue and Dyspnea to Improve Heart Failure Outcomes in African-Americans
African Americans have the highest risk for developing heart failure. When African Americans are diagnosed with heart failure (AAHF) it is usually more advanced HF compared to other races. African-Americans have the highest rate of hospitalization for HF compared to any other ethnic groups. Thus, life style modification, awareness of signs and symptoms of HF by continuous, rather than intermittent monitoring, is essential in beginning to develop HF interventions that can provide early detection. Early interventions would lead to reduced re-hospitalization, prevent hospital readmission and reduce the mortality rate associated with HF.
Symptoms of heart failure due to circulatory fluid overload: Signs of circulatory fluid
overload are theleading to cardiac decompensation or worsening heart failure are: orthopnea,
dyspnea, fatigue, weight gain, abdominal swelling, fluid retention, extended jugular vein,
leg edema, crackles, and ascites. Identifying early signs of CFO in HF would provide patients
more time to respond and self-manage symptoms at home.
Currently most HF patients are monitored intermittently for changes in symptoms
. According to the American Heart Association establishing self- monitoring practices is the
best method for improving health behaviors and health outcomes in individuals.
Fatigue and sleep in HF and gaps in symptom self-management: Fatigue in heart failure
patients was previously measured using a self-reported questionnaire and concluded that
identifying fatigue early could result in initiation of treatment to prevent HF
decompensation. A study by also concluded that severe HF symptoms are associated with higher
levels of fatigue in HF patients. found that increases in fatigue in cardiovascular patients
resulted in poorer self-care and poorer cardiovascular outcomes, but fatigue was not an
indication of disease severity. . Similarly another study concluded that there is a
relationship between sleep, fatigue and functional performance in HF patients. However,
sleep, fatigue and HF symptoms were only intermittently, rather than continuously, monitored
in these studies to assess its impact on HF patient outcomes.
The wrist-worn wearable device, Readiband (Fatigue Science)has a 93 accuracy rate in
measuring sleep. The Readiband and the biomathematical fatigue model SAFTE (Sleep, Activity,
Fatigue, and Task Effectiveness)have being successfully used to measure sleep and fatigue in
multiple areas of research The Readiband has a one month battery life and has the ability to
sync to mobile phones, or iPads via a Sync app. It allows for Minute-by-minute actigraphy
values and sleep/wake classification. The Readiband has the ability to track, high recurring
wake episodes, frequency of daytime sleep episodes, high sleep latency, wake after sleep
onset and total sleep quantity. The Readiband has been used successfully to measure fatigue
in athletes and law enforcement officers In the following studies the Readiband was use to
assess the correlation between sleep and fatigue: risk for accidents in medical residents
risk for making medical errors, and to predict football player's risk for injury Each study
has shown some level of statistical significance of the relationship between sleep and
fatigue. This study is adding another component of assessing if sleep and fatigue correlates
with increase severity of HF symptoms.The SAFTE Fatigue Model (Sleep, Activity, Fatigue, and
Task Effectiveness)will interpret the data collected from the Readiband. The SAFTE Fatigue
Model and the Readiband has never been use to monitor the correlation between sleep, fatigue
and decompensation in HF symptoms. The data from the Readiband will be transmitted to the
SAFTE Fatigue model. The data will analyze the patient sleep wake pattern to detect patient's
level of fatigue and data will be provided with the patient.
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