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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 : Recruiting
First Posted : November 30, 2017
Last Update Posted : November 19, 2018
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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
Heart Failure Device: Medly Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
Estimated Study Start Date : November 2018
Estimated Primary Completion Date : November 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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.



Primary Outcome Measures :
  1. Change in quality of life [ Time Frame: Baseline, 3 months ]
    Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12)


Secondary Outcome Measures :
  1. Change BNP/NT-pro BNP levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change BNP/NT-pro BNP levels

  2. Change in creatinine levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in creatinine levels

  3. Change in sodium levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in sodium levels

  4. Change in potassium levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]
    Change in potassium levels

  5. 30-day HF readmission rate [ Time Frame: 1 month ]
    30-day HF readmission rate

  6. Hospital length of stay [ Time Frame: 0 - 3 months ]
    Hospital length of stay

  7. Number of visits to the emergency department [ Time Frame: 0 - 3 months ]
    Number of visits to the emergency department

  8. 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

  9. Change in NHYA class [ Time Frame: Baseline, 3 months ]
    Change in NHYA class



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358303


Contacts
Contact: Emily Seto, PhD 416-669-9295 emily.seto@utoronto.ca
Contact: Alana Tibbles, MSc 416-303-0462 alana.tibbles@uhn.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Stephanie Poon, MD    416-480-6100 ext 2254    Stephanie.Poon@Sunnybrook.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Emily Seto, PhD University of Toronto

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03358303     History of Changes
Other Study ID Numbers: 17-5887
First Posted: November 30, 2017    Key Record Dates
Last Update Posted: November 19, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Heart Failure
Heart Diseases
Cardiovascular Diseases