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Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID)

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ClinicalTrials.gov Identifier: NCT03358303
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : December 15, 2017
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

November 24, 2017
November 30, 2017
December 15, 2017
February 2018
February 2019   (Final data collection date for primary outcome measure)
Change in quality of life [ Time Frame: Baseline, 3 months ]
Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire
  • Change in self-care of health failure [ Time Frame: Baseline, 3 months ]
    Change in self-care of health failure as measured by the Self-Care of Heart Failure Index
  • Change in quality of life [ Time Frame: Baseline, 3 months ]
    Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire
  • Change in NHYA class [ Time Frame: Baseline, 3 months ]
    Change in NHYA class
Complete list of historical versions of study NCT03358303 on ClinicalTrials.gov Archive Site
  • Change BNP/NT-pro BNP levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change BNP/NT-pro BNP levels
  • Change in creatinine levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in creatinine levels
  • Change in sodium levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in sodium levels
  • Change in potassium levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in potassium levels
  • 30-day HF readmission rate [ Time Frame: 1 month ]
    30-day HF readmission rate
  • Hospital length of stay [ Time Frame: 0 - 3 months ]
    Hospital length of stay
  • Number of visits to the emergency department [ Time Frame: 0 - 3 months ]
    Number of visits to the emergency department
  • Change in self-care of health failure [ Time Frame: Baseline, 3 months ]
    Change in self-care of health failure as measured by the Self-Care of Heart Failure Index
  • Change in NHYA class [ Time Frame: Baseline, 3 months ]
    Change in NHYA class
  • Change BNP/NT-pro BNP levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change BNP/NT-pro BNP levels
  • Change in creatinine levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in creatinine levels
  • Change in sodium levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in sodium levels
  • Change in potassium levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in potassium levels
  • 30-day HF readmission rate [ Time Frame: 1 month ]
    30-day HF readmission rate
  • Hospital length of stay [ Time Frame: 0 - 3 months ]
    Hospital length of stay
  • Number of visits to the emergency department [ Time Frame: 0 - 3 months ]
    Number of visits to the emergency department
Not Provided
Not Provided
 
Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Heart Failure
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.
  • 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.
    Intervention: Device: Medly
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
144
Same as current
February 2019
February 2019   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults (18 years or older)
  • Hospitalization for decompensated HF >24 hours
  • Patient speaks and reads English adequately to provide informed consent and understand the text prompts in the application
  • Ability to comply with using Medly (ex. able to stand on the weight scale, able to answer symptom questions, etc.)

Exclusion Criteria:

  • Dementia
  • Residents of long-term care facilities
  • Patients who will require inpatient rehabilitation after discharge
  • Participating in another clinical trial
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Emily Seto, PhD 416-669-9295 emily.seto@utoronto.ca
Not Provided
 
 
NCT03358303
17-5887
Not Provided
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
University Health Network, Toronto
University Health Network, Toronto
Not Provided
Principal Investigator: Emily Seto, PhD University of Toronto
University Health Network, Toronto
November 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP