Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation

NCT03358303 | Unknown

• 1 other identifier: 17-5887
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 3

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.

Conditions

Heart Failure

Keywords

telemonitoring; smartphone application

Outcome Measures

Primary Outcomes (5)

• Change in self-care of health failure

  Change in self-care of health failure as measured by the Self-Care of Heart Failure Index (SCHFI)

  Baseline, 3 months

• Change in quality of life

  Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and EuroQol (EQ5D)

  Baseline, 3 months

• Change BNP/NT-pro BNP levels

  Change BNP/NT-pro BNP levels

  Baseline, 1 month, 3 months

• Change in NYHA class

  Change in NYHA class

  Baseline, 1 month, 3 months

• Compliance with Medly utilization

  Ability to adhere to Medly program

  3 months

Secondary Outcomes (3)

• Hospital length of stay

  0 - 3 months

• 30-day HF readmission rate

  1 month, 3 months

• Number of visits to the emergency department

  0 - 3 months

Other Outcomes (3)

• Safety Endpoint: Change in creatinine levels

  Baseline, 1 month, 3 months

• Safety Endpoint: Change in sodium levels

  Baseline, 1 month, 3 months

• Safety Endpoint: Change in potassium levels

  Baseline, 1 month, 3 months

Study Arms (2)

Telemonitoring (Medly)

EXPERIMENTAL

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

Control

NO INTERVENTION

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.

Interventions

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.

Telemonitoring (Medly)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Sunnybrook Health Sciences Centre: collaborator
• MOUNT SINAI HOSPITAL: collaborator
• North York General Hospital: collaborator

Study Sites (3)

North York General Hospital

North York, Ontario, M2K 1E1, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

Related Publications (5)

• 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.

  PMID: 30806625 BACKGROUND

• 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.

  PMID: 30064970 BACKGROUND

• 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.

  PMID: 29724704 BACKGROUND

• 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.

  PMID: 22356799 BACKGROUND

• 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.

  PMID: 32012116 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Emily Seto, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2017
• First Posted: November 30, 2017
• Study Start: November 16, 2018
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: December 18, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3)