Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation (Medly-AID)
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|ClinicalTrials.gov Identifier: NCT03358303|
Recruitment Status : Not yet recruiting
First Posted : November 30, 2017
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Heart Failure||Device: Medly||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||144 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Health Services Research|
|Official Title:||Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation|
|Estimated Study Start Date :||February 2018|
|Estimated Primary Completion Date :||February 2019|
|Estimated Study Completion Date :||February 2019|
Experimental: Telemonitoring (Medly)
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.
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.
No Intervention: Control
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.
- Change in quality of life [ Time Frame: Baseline, 3 months ]Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire
- Change BNP/NT-pro BNP levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]Change BNP/NT-pro BNP levels
- Change in creatinine levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]Change in creatinine levels
- Change in sodium levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]Change in sodium levels
- Change in potassium levels [ Time Frame: Baseline, 2 weeks, 1 month, 3 months ]Change in potassium levels
- 30-day HF readmission rate [ Time Frame: 1 month ]30-day HF readmission rate
- Hospital length of stay [ Time Frame: 0 - 3 months ]Hospital length of stay
- Number of visits to the emergency department [ Time Frame: 0 - 3 months ]Number of visits to the emergency department
- 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
- Change in NHYA class [ Time Frame: Baseline, 3 months ]Change in NHYA class
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03358303
|Contact: Emily Seto, PhDfirstname.lastname@example.org|
|Principal Investigator:||Emily Seto, PhD||University of Toronto|