Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
NCT ID: NCT03358303
Last Updated: 2023-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
90 participants
INTERVENTIONAL
2018-11-16
2024-09-01
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Sunnybrook Health Sciences Centre
OTHER
MOUNT SINAI HOSPITAL
OTHER
North York General Hospital
OTHER
University Health Network, Toronto
OTHER
Responsible Party
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Principal Investigators
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Emily Seto, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Toronto
Locations
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North York General Hospital
North York, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Countries
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References
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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.
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.
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.
Other Identifiers
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17-5887
Identifier Type: -
Identifier Source: org_study_id