Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Heart Failure
- Sponsor
- University Health Network, Toronto
- Enrollment
- 90
- Locations
- 3
- Primary Endpoint
- Change in NYHA class
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Change in NYHA class
Time Frame: Baseline, 1 month, 3 months
Change in NYHA class
Compliance with Medly utilization
Time Frame: 3 months
Ability to adhere to Medly program
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)
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)
Change BNP/NT-pro BNP levels
Time Frame: Baseline, 1 month, 3 months
Change BNP/NT-pro BNP levels
Secondary Outcomes
- 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)