Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation

Study Overview
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Brief Summary
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Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized as a growing epidemic. Digital health interventions are the most recent iteration of an effort to promote individualized outpatient care through positive behaviour change theory. The UHN team has developed a highly automated and user-centered smartphone-based system, Medly, which allows for the telemonitoring of patients diagnosed with heart failure. The purpose of this study will be two-fold: 1) to determine if the introduction of Medly within two weeks of discharge will improve self-care management, quality of life, and clinical status, 2) to assess whether Medly will lead to a potential reduction in 30 day readmission rates amongst HF patients in the Toronto Central Local Health Integration Network (TC LHIN), without increasing the average length of stay or visits to the emergency department. These parameters will be measured as secondary outcomes.

Detailed Description
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Heart failure is the most rapidly rising cardiovascular disease and has come to be recognized as a growing epidemic. Digital health interventions are the most recent iteration of an effort to promote individualized outpatient care through positive behaviour change theory. The UHN team has developed a highly automated and user-centered smartphone-based system, Medly, which allows for the telemonitoring of patients diagnosed with heart failure Patients with heart failure will be provided with a smartphone and commercial home medical devices, such as a blood pressure monitor and weight scale. The measurements from the medical devices will be automatically sent to the smartphone, and from there to a data server at the hospital for analysis and storage. Both clinicians and patients will be able to access these data and will be sent alerts by the system if the measurements are outside of the normal range. The system will be evaluated through interviews and comparing outcomes between the intervention and control groups.

Official Title
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Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation

Conditions
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Heart Failure

Intervention / Treatment
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* Device: Medly


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults (18 years or older) Hospitalization for decompensated HF > 48 hours Patient speaks and reads English adequately to provide informed consent and understand the text prompts in the application (or has an informal caregiver who can translate for them) Ability to comply with using Medly (ex. able to stand on the weight scale, able to answer symptom questions, etc.) Exclusion Criteria: Dementia or uncontrolled psychiatric illness Residents of long-term care facilities Terminal diagnosis of any health condition with a life expectancy < 1 year Patients who will require inpatient rehabilitation after discharge Participating in another clinical trial that may confound the results

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Telemonitoring (Medly)<br>Medly is a smartphone application allows heart failure (HF) patients to measure and record their daily weight, blood pressure (BP), heart rate, and self-reported symptoms. This monitoring information is then transmitted wirelessly to a data server where an algorithm is used to generate an alert to a healthcare provider as necessary. The patient also receives an automated self-care message based on their measurements and reported symptoms. | Device: Medly<br>* Medly will enable patients with HF to take clinically relevant physiological measurements with wireless home medical devices and to answer symptom questions on the smartphone. The measurements will be automatically and wirelessly transmitted to the mobile phone and then to a data server. Automated self-care instructions/messages will be sent to the patient based on the readings and reported symptoms. If there are signs of their status deteriorating, an alert will be sent to a clinician that is responsible for the particular chronic condition of concern. The clinicians will have all the relevant patient data sent to them and will be able to access (through a secure web portal) to view historical and trending data for their patients.<br>|
| No Intervention: Control<br>Standard of care: Control groups will receive standard medical care when discharged from hospital, including discharge instructions, home medications as well as follow-up in a heart failure clinic or with a primary care doctor. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-care of health failure | Change in self-care of health failure as measured by the Self-Care of Heart Failure Index (SCHFI) | Baseline, 3 months | 
| Change in quality of life | Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and EuroQol (EQ5D) | Baseline, 3 months | 
| Change BNP/NT-pro BNP levels | Change BNP/NT-pro BNP levels | Baseline, 1 month, 3 months | 
| Change in NYHA class | Change in NYHA class | Baseline, 1 month, 3 months | 
| Compliance with Medly utilization | Ability to adhere to Medly program | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital length of stay | Hospital length of stay | 0 - 3 months | 
| 30-day HF readmission rate | 30-day HF readmission rate | 1 month, 3 months | 
| Number of visits to the emergency department | Number of visits to the emergency department | 0 - 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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telemonitoring, smartphone application