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OpenTrials
Completed

NCT Number: NCT02391987

Integrated Tele-monitoring and Patient-centric Health Coaching Strategy in Patients Hospitalized With Heart Failure

This study evaluates the effectiveness of remote tele-monitoring and health coaching in helping to reduce hospitalizations in heart failure patients. Half of participants will receive tele-monitoring and health coaching, while the other half will receive standard health care provided by their chosen provider.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic, Jacksonville, Florida, United States

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About this study

Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.

Health Coaching involves a team of health care professionals including a registered nurse (RN). The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hospitalized with primary or secondary diagnosis of Acute Decompensated Heart Failure (one or more of these symptoms: shortness of breath, orthopnea or edema AND one or more of these signs: rales, peripheral edema, ascites, or pulmonary vascular congestion on chest radiography)
  • Adult patients >18 years old

Exclusion criteria

  • Overall life expectancy < 1 year
  • Known skin allergy to adhesives (hydrocolloid, silicone, acrylic)
  • Active systemic infection
  • Pregnant or lactating
  • End stage renal disease on dialysis
  • Subject or caregiver is not visually and tactile capable of smartphone and home device usage
  • Inadequate cell phone coverage (including international patients or international travel during study period)
  • Subject or legal guardian is not willing and able to provide appropriate informed consent

Treatment and study plan

Tele-monitoring and health coaching

Device

Tele-monitoring involves a personal monitoring system used to analyze data to provide relevant health information back to the treating clinician and the user. The monitoring system remotely monitors electrocardiographic (ECG) signals, heart rate, breathing rate, and activity levels. Additional devices will be integrated with the monitoring device to assess blood pressure and weight.

Health Coaching involves a team of health care professionals including a registered nurse (RN) . The health care team creates a plan specific to the patient and provides guidance on nutrition' medications, and exercise. The data collected by the remote monitoring device will assist the care team in patient management.

Primary outcomes

  1. Hospital Readmission

    Time frame: 60 days

    Occurrence of all-cause hospital readmissions or death within 60 days

Secondary outcomes

  1. Number of Readmissions or Visits

    Time frame: 60 days

    Number of hospital readmissions or emergency room visits (visits without admissions)

  2. Mortality

    Time frame: 60 days

    All-cause mortality

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Preventice

Registry information

Official study title

A Randomized Study of the Effectiveness of an Integrated Tele-monitoring and Patient-centric Health Coaching Strategy (Tele-HC) in Adult Patients Recently Hospitalized With Acute Decompensated Heart Failure (ADHF) Compared to Standard Care

Acronym: Tele-HC

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 18, 2015
Registry last updated
Jan 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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