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Use of Telemonitoring to Facilitate Heart Failure Medication Titration

NCT04205513 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-03-19

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Medly

Medly is a mobile phone-based telemonitoring system that enables patients with heart failure to take clinically relevant physiological measurements with wireless home medical devices and answer symptom questions on the mobile phone. The measurements are automatically and wirelessly transmitted to the mobile phone and then to a data server.

Sponsors & Collaborators

  • University Health Network, Toronto

    lead OTHER

Principal Investigators

  • Emily Seto, PhD · University Health Network, Toronto

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-01-01
Primary Completion
2022-12-31
Completion
2024-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04205513 on ClinicalTrials.gov