Medly-AID: Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Telemonitoring (Medly) 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
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.
|
| No Intervention: Control 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. |
Outcome Measures
Primary Outcome Measures
- Change in self-care of health failure [Baseline, 3 months]
Change in self-care of health failure as measured by the Self-Care of Heart Failure Index (SCHFI)
- Change in quality of life [Baseline, 3 months]
Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and EuroQol (EQ5D)
- Change BNP/NT-pro BNP levels [Baseline, 2 weeks, 1 month, 3 months]
Change BNP/NT-pro BNP levels
- Change in NYHA class [Baseline, 3 months]
Change in NYHA class
- Compliance with Medly utilization [3 months]
Ability to adhere to Medly program
Secondary Outcome Measures
- Hospital length of stay [0 - 3 months]
Hospital length of stay
- 30-day HF readmission rate [1 month]
30-day HF readmission rate
- Number of visits to the emergency department [0 - 3 months]
Number of visits to the emergency department
Other Outcome Measures
- Safety Endpoint: Change in creatinine levels [Baseline, 2 weeks, 1 month, 3 months]
Change in creatinine levels
- Safety Endpoint: Change in sodium levels [Baseline, 2 weeks, 1 month, 3 months]
Change in sodium levels
- Safety Endpoint: Change in potassium levels [Baseline, 2 weeks, 1 month, 3 months]
Change in potassium levels
Eligibility Criteria
Criteria
Inclusion Criteria:
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Adults (18 years or older)
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Hospitalization for decompensated HF > 48 hours
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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)
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Ability to comply with using Medly (ex. able to stand on the weight scale, able to answer symptom questions, etc.)
Exclusion Criteria:
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Dementia or uncontrolled psychiatric illness
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Residents of long-term care facilities
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Terminal diagnosis of any health condition with a life expectancy < 1 year
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Patients who will require inpatient rehabilitation after discharge
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Participating in another clinical trial that may confound the results
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | North York General Hospital | North York | Ontario | Canada | M2K 1E1 |
| 2 | Sunnybrook Health Sciences Centre | Toronto | Ontario | Canada | M4N 3M5 |
| 3 | Mount Sinai Hospital | Toronto | Ontario | Canada | M5G 1X5 |
Sponsors and Collaborators
- University Health Network, Toronto
- Sunnybrook Health Sciences Centre
- MOUNT SINAI HOSPITAL
- North York General Hospital
Investigators
- Principal Investigator: Emily Seto, PhD, University of Toronto
Study Documents (Full-Text)
None provided.More Information
Publications
- 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.
- 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.
- 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.
- 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.
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