Heart Failure
Conditions
Keywords
telemonitoring, smartphone application
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.
Interventions
DEVICEMedly
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.
Sponsors
University Health Network, Toronto
Sunnybrook Health Sciences Centre
MOUNT SINAI HOSPITAL
North York General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in self-care of health failure | Baseline, 3 months | Change in self-care of health failure as measured by the Self-Care of Heart Failure Index (SCHFI) |
| Change in quality of life | Baseline, 3 months | Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and EuroQol (EQ5D) |
| Change BNP/NT-pro BNP levels | Baseline, 1 month, 3 months | Change BNP/NT-pro BNP levels |
| Change in NYHA class | Baseline, 1 month, 3 months | Change in NYHA class |
| Compliance with Medly utilization | 3 months | Ability to adhere to Medly program |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hospital length of stay | 0 - 3 months | Hospital length of stay |
| 30-day HF readmission rate | 1 month, 3 months | 30-day HF readmission rate |
| Number of visits to the emergency department | 0 - 3 months | Number of visits to the emergency department |
Countries
Canada
Contacts
PRINCIPAL_INVESTIGATOREmily Seto, PhD
University of Toronto
Outcome results
None listed