Clinical trial NCT03358303: Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
Official title: Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Heart Failure
Keywords: telemonitoring
smartphone application
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Sunnybrook Health Sciences Centre
name: MOUNT SINAI HOSPITAL
name: North York General Hospital
First posted: 2017-11-30
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility 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 (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

Primary outcomes:
measure: Change in self-care of health failure
timeFrame: Baseline, 3 months
measure: Change in quality of life
timeFrame: Baseline, 3 months
measure: Change BNP/NT-pro BNP levels
timeFrame: Baseline, 1 month, 3 months
measure: Change in NYHA class
timeFrame: Baseline, 1 month, 3 months
measure: Compliance with Medly utilization
timeFrame: 3 months
Secondary outcomes:
measure: Hospital length of stay
timeFrame: 0 - 3 months
measure: 30-day HF readmission rate
timeFrame: 1 month, 3 months
measure: Number of visits to the emergency department
timeFrame: 0 - 3 months
Other outcomes:
measure: Safety Endpoint: Change in creatinine levels
timeFrame: Baseline, 1 month, 3 months
measure: Safety Endpoint: Change in sodium levels
timeFrame: Baseline, 1 month, 3 months
measure: Safety Endpoint: Change in potassium levels
timeFrame: Baseline, 1 month, 3 months
Locations:
city: North York
country: Canada
facility: North York General Hospital
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Emily Seto, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.