Telemonitoring for Heart Failure

(Medly Titrate Trial)

Overseen By Veronica Kirk

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University Health Network, Toronto

Must be taking: Ace inhibitors, Beta blockers

Disqualifiers: Congenital heart disease, Heart transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

Duration: 6 months

108 Participants Needed

Trial Summary

What is the purpose of this trial?

Heart failure (HF) is a common diagnosis with high prevalence, reduced life expectancy and a significant clinical and economic burden. Large-scale randomized controlled trials have demonstrated that combination drug therapy, optimized to maximal tolerated doses, improves clinical outcomes in HF patients. However, evidence suggests that in clinical practice many patients never achieve target doses. Barriers to medication titration include provider and patient-related factors, as well as limited time and support facilities to enable regular monitoring. Telemonitoring is a potential component in the management of HF that can provide reliable and real-time physiological data for clinical decision support, alerting, and patient self-management. The primary objective of this study is to evaluate the effectiveness and safety of the implementation of telemonitoring to facilitate HF medication titration. The secondary objective is to obtain a deeper understanding of the experience of clinicians and HF patients taking part in the remote titration program. The study will be conducted at the Peter Munk Cardiac Centre (PMCC), University Health Network, in Toronto. It will be based on a mixed methods effectiveness-implementation hybrid design and incorporate process evaluations alongside assessment of clinical outcomes. The effectiveness research component will be assessed via a 2-arm randomized controlled trial (RCT), which will enroll 108 patients in total. The RCT will compare a predefined remote titration management strategy, which will utilize data from a smartphone-based telemonitoring system, with a standard titration management strategy consisting of regular in-office visits, and assess the efficacy and safety of the telemonitoring system in facilitating titration. The implementation research component will consist of a qualitative study based on semi-structured interviews with a purposive sample of clinicians and patients, and assess the factors that can positively impact the implementation and effectiveness of the intervention.

Research Team

Emily Seto, PhD

Principal Investigator

University Health Network, Toronto

Eligibility Criteria

This trial is for adults with heart failure (NYHA Class II-III) who are not yet on target doses of heart failure medication, can give informed consent, speak and read English well enough to use the Medly app, and have a left ventricular ejection fraction of 40% or less. They should be stable with no recent hospitalizations and able to use the telemonitoring equipment.

Inclusion Criteria

You have heart problems that make it difficult for you to do everyday activities.

Patient is able to provide informed consent to participate in the program

Patient or their informal caregiver speaks and reads English adequately to participate in the program and understand the alerts/prompts in the Medly application

Exclusion Criteria

Patients will be excluded from the study based on the clinical judgment of their healthcare provider

Already on target doses of guideline-directed medical therapy (GDMT)

You have a severe, active heart failure.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive telemonitoring-based medication titration for heart failure management

6 months

Telephone contacts at 2-week intervals

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Implementation Evaluation

Qualitative interviews with patients and providers to assess implementation barriers and facilitators

Throughout study completion

Treatment Details

Interventions

• Telemonitoring

Trial Overview The study tests if using a smartphone-based telemonitoring system called Medly can help patients adjust their heart failure medications better than regular in-office visits. It's a randomized controlled trial comparing these two strategies at the Peter Munk Cardiac Centre.

Participant Groups

Group I: Study Group Experimental Treatment 1 Intervention

Remote titration management strategy, consisting of telephone contacts, which will utilize data from the Medly system.

Group II: Control Group Active Control 1 Intervention

Standard titration management strategy, consisting of regular in-office visits.

Telemonitoring is already approved in Canada, European Union, United States for the following indications:

Approved in Canada as Telemonitoring for:

• Heart Failure
• Diabetes
• Hypertension
• COPD
• Depression

Approved in European Union as Telemonitoring for:

• Heart Failure
• Diabetes
• Hypertension
• COPD

Approved in United States as Telemonitoring for:

• Heart Failure
• Diabetes
• Hypertension
• COPD

Who Is Running the Clinical Trial?

University Health Network, Toronto

Lead Sponsor

Trials

1,555

Recruited

526,000+