Abstract
BackgroundAn 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/DesignA 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.DiscussionOutcomes 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 NumberACTRN12607000594426
Highlights
An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030
Outcomes will provide evidence concerning the efficacy of a telephone-linked care intervention for self-management of diabetes
This paper presents the study protocol for a randomised controlled trial (RCT) of a Telephone-Linked Care (TLC) system aiming to improve type 2 diabetes management, TLC Diabetes
Summary
An estimated 285 million people worldwide have diabetes and its prevalence is predicted to increase to 439 million by 2030. Systematic reviews of interventions targeting diabetes self-management indicate that the effectiveness of these programs is significantly related to their duration [6,7] This emphasises the importance of ongoing follow-up and support for successful long-term glycaemic control [8]. The delivery of ongoing support to the fast growing number of people living with diabetes presents a real challenge for most health systems and this will not be addressed by any modest increase in the number of relevant health professionals to provide such services. Addressing this challenge requires new cost-effective approaches that will reach a large number of individuals regularly, in particular, those people who already have poor access to current services, due to geographical, financial or other barriers
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