Abstract
BackgroundDespite 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/DesignRandomized 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.DiscussionThe 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 registrationBelgian number: B322201213625. ClinicalTrials.gov Identifier: NCT01612520
Highlights
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
The specific aims of the study are: 1) to assess whether The COACH Program can be offered by a sickness fund and delivered in cooperation with caregivers in Belgium; 2) to investigate whether The COACH Program helps people with type 2 diabetes to achieve better glycemic control and improved modifiable diabetes risk factors and self-perceived health compared with usual care alone; 3) to analyze the cost-effectiveness of The COACH Program from the perspective of the health care system based on the trial results extrapolated to a life-long horizon
Telephone coaching has been applied for patient education in USA and Australia since 1990-ties and has a potential to increase access to health care services
Summary
Local context can have impact on the acceptability of new forms of care and on their clinical- and costeffectiveness. To increase the added value of such research to patients and policy makers, study designs have to consider the clinical effectiveness, the costeffectiveness and the implementation potential. 1) The intervention integrity analysis is integrated into the study protocol. The funding sources have no role in the design, conduct, or analysis of the study or in the publication decisions. 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. 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.
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