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| Name | Class |
|---|---|
| Sunnybrook Health Sciences Centre | OTHER |
| MOUNT SINAI HOSPITAL | OTHER |
| North York General Hospital | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Telemonitoring (Medly) | Experimental | 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. |
|
| Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medly | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint: Change in creatinine levels | Change in creatinine levels | Baseline, 1 month, 3 months |
| Safety Endpoint: Change in sodium levels | Change in sodium levels |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emily Seto, PhD | University of Toronto | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| North York General Hospital | North York | Ontario | M2K 1E1 | Canada | ||
| Sunnybrook Health Sciences Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30806625 | Background | Ware P, Dorai M, Ross HJ, Cafazzo JA, Laporte A, Boodoo C, Seto E. Patient Adherence to a Mobile Phone-Based Heart Failure Telemonitoring Program: A Longitudinal Mixed-Methods Study. JMIR Mhealth Uhealth. 2019 Feb 26;7(2):e13259. doi: 10.2196/13259. | |
| 30064970 | Background | Ware P, Ross HJ, Cafazzo JA, Laporte A, Gordon K, Seto E. Evaluating the Implementation of a Mobile Phone-Based Telemonitoring Program: Longitudinal Study Guided by the Consolidated Framework for Implementation Research. JMIR Mhealth Uhealth. 2018 Jul 31;6(7):e10768. doi: 10.2196/10768. |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| Number of visits to the emergency department | Number of visits to the emergency department | 0 - 3 months |
| Baseline, 1 month, 3 months |
| Safety Endpoint: Change in potassium levels | Change in potassium levels | Baseline, 1 month, 3 months |
| Toronto |
| Ontario |
| M4N 3M5 |
| Canada |
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada |
| 29724704 | Background | Ware P, Ross HJ, Cafazzo JA, Laporte A, Seto E. Implementation and Evaluation of a Smartphone-Based Telemonitoring Program for Patients With Heart Failure: Mixed-Methods Study Protocol. JMIR Res Protoc. 2018 May 3;7(5):e121. doi: 10.2196/resprot.9911. |
| 22356799 | Background | Seto E, Leonard KJ, Cafazzo JA, Barnsley J, Masino C, Ross HJ. Mobile phone-based telemonitoring for heart failure management: a randomized controlled trial. J Med Internet Res. 2012 Feb 16;14(1):e31. doi: 10.2196/jmir.1909. |
| 32012116 | Derived | Seto E, Ross H, Tibbles A, Wong S, Ware P, Etchells E, Kobulnik J, Chibber T, Poon S. A Mobile Phone-Based Telemonitoring Program for Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2020 Jan 22;9(1):e15753. doi: 10.2196/15753. |