Effects of Telemonitoring on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation

Heart Failure Clinical Trial

— Medly-AID  

Official title:

Effect of a Mobile Phone-based Telemonitoring Program on the Outcome of Heart Failure Patients After an Incidence of Acute Decompensation

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03358303
• Other study ID #: 17-5887
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 16, 2018
• Est. completion date: September 1, 2024

Study information

• Verified date: May 2023
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 90
• Est. completion date: September 1, 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Device:
• Medly
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.

Locations

Country	Name	City	State
Canada	North York General Hospital	North York	Ontario
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	Sunnybrook Health Sciences Centre	Toronto	Ontario

Sponsors (4)

Lead Sponsor	Collaborator
University Health Network, Toronto	MOUNT SINAI HOSPITAL, North York General Hospital, Sunnybrook Health Sciences Centre

Country where clinical trial is conducted

Canada, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety Endpoint: Change in creatinine levels	Change in creatinine levels	Baseline, 1 month, 3 months
Other	Safety Endpoint: Change in sodium levels	Change in sodium levels	Baseline, 1 month, 3 months
Other	Safety Endpoint: Change in potassium levels	Change in potassium levels	Baseline, 1 month, 3 months
Primary	Change in self-care of health failure	Change in self-care of health failure as measured by the Self-Care of Heart Failure Index (SCHFI)	Baseline, 3 months
Primary	Change in quality of life	Change in quality of life, as measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ-12) and EuroQol (EQ5D)	Baseline, 3 months
Primary	Change BNP/NT-pro BNP levels	Change BNP/NT-pro BNP levels	Baseline, 1 month, 3 months
Primary	Change in NYHA class	Change in NYHA class	Baseline, 1 month, 3 months
Primary	Compliance with Medly utilization	Ability to adhere to Medly program	3 months
Secondary	Hospital length of stay	Hospital length of stay	0 - 3 months
Secondary	30-day HF readmission rate	30-day HF readmission rate	1 month, 3 months
Secondary	Number of visits to the emergency department	Number of visits to the emergency department	0 - 3 months