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01.12.2014 | Study protocol | Ausgabe 1/2014 Open Access

BMC Family Practice 1/2014

Nurse-led telecoaching of people with type 2 diabetes in primary care: rationale, design and baseline data of a randomized controlled trial

Zeitschrift:
BMC Family Practice > Ausgabe 1/2014
Autoren:
Irina Odnoletkova, Geert Goderis, Frank Nobels, Bert Aertgeerts, Lieven Annemans, Dirk Ramaekers
Wichtige Hinweise

Electronic supplementary material

The online version of this article (doi:10.​1186/​1471-2296-15-24) contains supplementary material, which is available to authorized users.

Competing interests

The principal investigator (IO) conducts this project as part of her job as employee of the Independent Sickness Funds of Belgium and her PhD at the University of Leuven, Faculty of Biomedical Sciences, Department of Public Health. The authors have no financial interest in this research. The RCT is subsidized by the European Regional Development Fund and the Flemish Government. Other sources of project financing are Partena, MSD and Abbott. The latter two have provided a scientific grant for the clinical trial. The funding sources have no role in the design, conduct, or analysis of the study or in the publication decisions. We thank Mesh and Tabakstop for providing measuring devices for the purpose of the trial.

Authors’ contributions

IO developed the study protocol and has been managing the research and the intervention implementation. GG critically revised the protocol and the intervention training manuals for coaches and assisted with the statistical analysis. FN critically revised the protocol and assisted with the adaptation of The COACH Program to the Belgian context. BA contributed to the revision of the training manuals for coaches, the design of the protocol and the final approval of the publication draft. LA and DR contributed to the design of the protocol and the final approval of the publication draft. All authors read and approved the final manuscript.

Abstract

Background

Despite the efforts of the healthcare community to improve the quality of diabetes care, about 50% of people with type 2 diabetes do not reach their treatment targets, increasing the risk of future micro-and macro-vascular complications. Diabetes self-management education has been shown to contribute to better disease control. However, it is not known which strategies involving educational programs are cost-effective. Telehealth applications might support chronic disease management. Transferability of successful distant patient self-management support programs to the Belgian setting needs to be confirmed by studies of a high methodological quality. “The COACH Program” was developed in Australia as target driven educational telephone delivered intervention to support people with different chronic conditions. It proved to be effective in patients with coronary heart disease after hospitalization. Clinical and cost-effectiveness of The COACH Program in people with type 2 diabetes in Belgium needs to be assessed.

Methods/Design

Randomized controlled trial in patients with type 2 diabetes. Patients were selected based on their medication consumption data and were recruited by their sickness fund. They were randomized to receive either usual care plus “The COACH Program” or usual care alone. The study will assess the difference in outcomes between groups. The primary outcome measure is the level of HbA1c. The secondary outcomes are: Total Cholesterol, LDL-Cholesterol, HDL-Cholesterol, Triglycerides, Blood Pressure, body mass index, smoking status; proportion of people at target for HbA1c, LDL-Cholesterol and Blood Pressure; self-perceived health status, diabetes-specific emotional distress and satisfaction with diabetes care. The follow-up period is 18 months. Within-trial and modeled cost-utility analyses, to project effects over life-time horizon beyond the trial duration, will be undertaken from the perspective of the health care system if the intervention is effective.

Discussion

The study will enhance our understanding of the potential of telehealth in diabetes management in Belgium. Research on the clinical effectiveness and the cost-effectiveness is essential to support policy makers in future reimbursement and implementation decisions.

Trial registration

Belgian number: B322201213625. ClinicalTrials.gov Identifier: NCT01612520
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