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NCT Number: NCT03358303

Effects of Telemonitoring 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

North York General Hospital, North York, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 (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

  • Dementia or uncontrolled psychiatric illness
  • 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

Treatment and study plan

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.

Primary outcomes

  1. 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 (SCHFI)

  2. 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) and EuroQol (EQ5D)

  3. Change BNP/NT-pro BNP levels

    Time frame: Baseline, 1 month, 3 months

    Change BNP/NT-pro BNP levels

  4. Change in NYHA class

    Time frame: Baseline, 1 month, 3 months

    Change in NYHA class

  5. Compliance with Medly utilization

    Time frame: 3 months

    Ability to adhere to Medly program

Secondary outcomes

  1. Hospital length of stay

    Time frame: 0 - 3 months

    Hospital length of stay

  2. 30-day HF readmission rate

    Time frame: 1 month, 3 months

    30-day HF readmission rate

  3. Number of visits to the emergency department

    Time frame: 0 - 3 months

    Number of visits to the emergency department

Other outcomes

  1. Safety Endpoint: Change in creatinine levels

    Time frame: Baseline, 1 month, 3 months

    Change in creatinine levels

  2. Safety Endpoint: Change in sodium levels

    Time frame: Baseline, 1 month, 3 months

    Change in sodium levels

  3. Safety Endpoint: Change in potassium levels

    Time frame: Baseline, 1 month, 3 months

    Change in potassium levels

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Collaborators

  • MOUNT SINAI HOSPITAL
  • North York General Hospital
  • Sunnybrook Health Sciences Centre

Registry information

Official study title

Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation

Acronym: Medly-AID

Important dates

Study start
2018
Primary completion
2023
Study completion
2026
First posted
Nov 30, 2017
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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