Abstract
BackgroundThe objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza.Methods/designThis is a prospective phase IV cluster clinical trial conducted under routine conditions in 14 primary health care centres of Osakidetza, randomly assigned to an intervention or control group. We will recruit a total sample of 1089 individuals, aged between 45 and 70 years old, without diabetes but at high risk of developing the condition (Finnish Diabetes Risk Score, FINDRISC ≥ 14) and follow them up for 2 years. Primary health care nursing teams of the intervention centres will implement DE-PLAN, a structured educational intervention program focused on changing healthy lifestyles (diet and physical activity); while the patients in the control centres will receive the usual care for the prevention and treatment of DM2 currently provided in Osakidetza. The effectiveness attributable to the programme will be assessed by comparing the changes observed in patients exposed to the intervention and those in the control group, with respect to the risk of developing DM2 and lifestyle habits. In terms of feasibility, we will assess indicators of population coverage and programme implementation.DiscussionThe aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2. The study design will enable us to gather information on the effectiveness of the intervention as well as the feasibility of implementing it in routine practice.Trial registrationClinicalTrials.gov NCT01365013
Highlights
The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza
The aim of this study is to provide the scientific basis for disseminate the programme to the remaining primary health centres in Osakidetza, as a novel way of addressing prevention of DM2
Feasibility of the implementation of the programme and its components The following indicators will be assessed: a) adoption of the programme, in terms of percentage of health professionals that carry out various different components of the intervention; representativeness, dropout rate, causes and degree of influence of the dropout rate on outcomes; b) reach of the programme, in term of percentage of patients exposed to the programme, dropout rate, causes and degree of influence of the dropout rate on the outcomes; and c) implementation of the components of the programme, in terms of degree to which participating patients had received the various different components of the programme as planned
Summary
The objective of this study is to perform an independent evaluation of the feasibility and effectiveness of an educational programme for the primary prevention of type 2 diabetes (DM2) in high risk populations in primary care settings, implanted within the Basque Health Service - Osakidetza. It has been estimated that half of the population of Europe will have hyperglycaemia or diabetes during their lives [3], these conditions becoming more prevalent among both elderly and young people, with a sudden increase in those below 30 years of age [4]. This dramatic increase in the recently diagnosed cases of DM2 and its complications have become an important public health problem and affect almost all populations in both developed and developing countries [1,5]
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