Ignite Creation Date:
2025-12-24 @ 7:39 PM
Ignite Modification Date:
2025-12-31 @ 12:56 AM
Study NCT ID:
NCT03358303
Status:
UNKNOWN
Last Update Posted:
2023-12-18
First Post:
2017-11-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
Sponsor:
University Health Network, Toronto
Organization:
Study Overview
Official Title:
Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation
Status:
UNKNOWN
Status Verified Date:
2023-05
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Medly-AID
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: