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Open Access Study protocol

Randomised controlled trial of an automated, interactive telephone intervention to improve type 2 diabetes self-management (Telephone-Linked Care Diabetes Project): study protocol

Dominique Bird1*, Brian Oldenburg1, Mandy Cassimatis2, Anthony Russell34, Susan Ash5, Mary D Courtney6, Paul A Scuffham7, Ian Stewart5, Richard Wootton8 and Robert H Friedman9

Author Affiliations

1 Department of Epidemiology and Preventive Medicine, School of Public Health and Preventive Medicine, Monash University, 3rd Floor Burnett Building The Alfred Hospital, Melbourne, 3004, Australia

2 Centre for Online Health, University of Queensland, Brisbane, Australia

3 Diamantina Institute, University of Queensland, Princess Alexandra Hospital, Brisbane, Australia

4 Department of Diabetes and Endocrinology, Princess Alexandra Hospital, Brisbane, Australia

5 Institute of Health and Biomedical Innovation, Queensland University of Technology, Brisbane, Australia

6 Faculty of Health and Social Development, University of British Columbia, Vancouver, Canada

7 Centre for Applied Health Economics, School of Medicine, Griffith University, Logan, Australia

8 Norwegian Centre for Integrated Care and Telemedicine, University Hospital of North Norway, Tromsø, Norway

9 Medical Information Systems Unit, Boston Medical Center, Boston University, Boston, USA

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BMC Public Health 2010, 10:599  doi:10.1186/1471-2458-10-599

Published: 12 October 2010

Abstract

Background

An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. For the year 2010, it is estimated that 3.96 million excess deaths in the age group 20-79 years are attributable to diabetes around the world. Self-management is recognised as an integral part of diabetes care. This paper describes the protocol of a randomised controlled trial of an automated interactive telephone system aiming to improve the uptake and maintenance of essential diabetes self-management behaviours.

Methods/Design

A total of 340 individuals with type 2 diabetes will be randomised, either to the routine care arm, or to the intervention arm in which participants receive the Telephone-Linked Care (TLC) Diabetes program in addition to their routine care. The intervention requires the participants to telephone the TLC Diabetes phone system weekly for 6 months. They receive the study handbook and a glucose meter linked to a data uploading device. The TLC system consists of a computer with software designed to provide monitoring, tailored feedback and education on key aspects of diabetes self-management, based on answers voiced or entered during the current or previous conversations. Data collection is conducted at baseline (Time 1), 6-month follow-up (Time 2), and 12-month follow-up (Time 3). The primary outcomes are glycaemic control (HbA1c) and quality of life (Short Form-36 Health Survey version 2). Secondary outcomes include anthropometric measures, blood pressure, blood lipid profile, psychosocial measures as well as measures of diet, physical activity, blood glucose monitoring, foot care and medication taking. Information on utilisation of healthcare services including hospital admissions, medication use and costs is collected. An economic evaluation is also planned.

Discussion

Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes. Furthermore, the study will provide insight into the potential for more widespread uptake of automated telehealth interventions, globally.

Trial Registration Number

ACTRN12607000594426