Introduction Chronic heart failure (CHF) is a life-threatening chronic disease characterised by periodic exacerbations and recurrent hospitalisations. In the management of CHF, patient compliance with evidence-based clinical guidelines is essential, but remains difficult practically. The objective of this study is to examine whether an Innovative Telemonitoring Enhanced Care Programme for CHF (ITEC-CHF) improves patients’ compliance, and associated health and economic outcomes.
Methods and analysis An open multicentre randomised controlled trial has been designed. Patients will be recruited and randomised to receive either ITEC-CHF (n=150) or usual care CHF (n=150) for at least 6 months. ITEC-CHF combines usual care and an additional telemonitoring service including remote weight monitoring, structured telephone support and nurse-led collaborative care. The primary outcomes are the compliance rates with the best-practice guidelines for daily weight monitoring. The secondary outcomes include the compliance with other guideline recommendations (health maintenance, medication, diet and exercise), health (health-related quality of life, risk factors, functional capacity and psychological states) and economic outcomes related to the use of healthcare resources such as hospital readmissions and general practitioner/emergency department visits.
Ethics and dissemination The clinical trial has been approved by Peninsula Health Human Research Ethics Committee (HREC Reference: HREC/14/PH/27), Royal Perth Hospital Human Research Ethics Committee (Reference: 15-081) and the Curtin University Human Research Ethics Committee (Reference: HR 181/2014). We will disseminate the final results to the public via conferences and journal publications. A final study report will also be provided to the ethics committees.
Trial registration number Registered with Australian New Zealand Clinical Trial Registry (ACTRN12614000916640).
- heart failure
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Contributors This study protocol was mainly developed by HD, AD, IE and RJ. The first draft of the manuscript was written by HD and RJ. All other authors contributed to the design of the clinical study, and/or critical revision of the manuscript.
Funding This project is fully funded by the Health Market Validation Program by Department of State Development, Business and Innovation, Victorian government (121 Exhibition Street, Melbourne, VIC 3001, Australia; the contract was signed in May 2014) and Western Australia Targeted Research Fund Grant by the Department of Health, Western Australia (Notification, 4 February 2014). Primary trial sponsor: Peninsula Health, contact name: IE.
Disclaimer These funding sponsors will not have any roles in the design of this study, execution of the trial, analysis and interpretation of the trial data, and research publications.
Competing interests None declared.
Ethics approval Peninsula Health Human Research Ethics Committee, Royal Perth Hospital Human Research Ethics Committee and the Curtin University Human Research Ethics Committee.
Provenance and peer review Not commissioned; externally peer reviewed.
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