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Randomized Controlled Trial
. 2017 Oct 8;7(10):e017550.
doi: 10.1136/bmjopen-2017-017550.

Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

Hang Ding  1 , Rajiv Jayasena  2 , Andrew Maiorana  3   4 , Alison Dowling  5 , Sheau Huey Chen  4 , Mohan Karunanithi  1 , Jamie Layland  6 , Iain Edwards  5
Affiliations
Randomized Controlled Trial

Innovative Telemonitoring Enhanced Care Programme for Chronic Heart Failure (ITEC-CHF) to improve guideline compliance and collaborative care: protocol of a multicentre randomised controlled trial

Hang Ding et al. BMJ Open. .

Abstract

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).

Keywords: compliance; heart failure; internet; telehealth.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
Trial flow diagram of the two-arm randomised controlled trail to compare the Innovative Telemonitoring Enhanced Care Programme for Congestive Heart Failure (ITEC-CHF) with usual care CHF (UC-CHF).
Figure 2
Figure 2
The care model of the Innovative Telemonitoring Enhanced Care Programme for Congestive Heart Failure is integrated within usual care. The integration includes: (1) remote weight monitoring, (2) structured telephone support and (3) nurse-led collaborative care. GP, general practitioner.
See this image and copyright information in PMC

References

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