چکیده (انگلیسی):

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