INTEGRA study protocol : primary care intervention in type 2 diabetes patients with poor glycaemic control
Molló, Àngels (Institut Català de la Salut. Centre d'Atenció Primària de Cervera)
Berenguera, Anna (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Rubinat, Esther (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Vlacho, Bogdan (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Mata, Manel (Institut Català de la Salut)
Franch-Nadal, Josep (Institut Català de la Salut. Centre d'Atenció Primària Raval Sud (Barcelona, Catalunya))
Bolíbar, Bonaventura (Institut Universitari d'Investigació en Atenció Primària Jordi Gol)
Mauricio Puente, Dídac (Institut d'Investigació Biomèdica Sant Pau)
Universitat Autònoma de Barcelona

Data:	2019
Resum:	The management of hyperglycaemia and associated cardiovascular risk factors in patients with type 2 diabetes mellitus (T2DM) may reduce diabetes-related complications. The strategy to broaden the knowledge base of primary care professionals to improve health care has mainly been prompted by the current reality of limited resources and access to specialized care. The main objective of this study is to assess the effectiveness of comprehensive interventions focused on treatment intensification, decrease clinical inertia and reduce possible barriers to treatment adherence in patients with poorly controlled diabetes in a primary care setting. This is a two-phase mixed method study, whose aims are the development of complex interventions and the assessment of their effectiveness. The main study outcome is a change in glycated haemoglobin (HbA1c) levels. The INTEGRA study is divided into two phases. Phase 1: A qualitative study with a phenomenological approach using semi-structured interviews with the objective of determining the factors related to the participants and health care professionals that influence the development and implementation of a specific intervention strategy aimed at patients with poor glycaemic control of T2DM in primary care. Phase 2: Exploratory intervention study to be conducted in Primary Health Care Centres in Catalonia (Spain), including 3 specific health care areas. The intervention study has two arms: Intervention Group 1 and 2. Each intervention group will recruit 216 participants (the same as in the control group) between the ages of 30 and 80 years with deficient glycaemic control (HbA1c 9%). The control group will be established based on a randomized selection from the large SIDIAP (Sistema d'Informació per al desenvolupament de la Investigació en Atenció Primària) database of patients with comparable socio-demographic and clinical characteristics from the three provinces. This study is a comprehensive, pragmatic intervention based on glycaemic treatment intensification and the control of other cardiovascular risk factors. It is also aimed at improving treatment adherence and reducing clinical inertia, which could lead to improved glycaemic control and could likewise be feasible for implementation in the actual clinical practice of primary care. registration number. NCT02663245; January 25, 2016. The online version of this article (10. 1186/s12875-019-0916-9) contains supplementary material, which is available to authorized users.
Nota:	Altres ajuts: The study is partially supported by unrestricted grant from Sanofi. The study has also intramural support from Institut Universitari d'Investigació en Atenció Primària Jordi Gol. The funder does not have any role in writing the study protocol. This funding source will not have any role during its execution, analyses, interpretation of the data, or decision to submit results.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, fins i tot amb finalitats comercials, sempre i quan es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Glycated haemoglobin ; Clinical inertia ; Intervention ; Primary care ; Type 2 diabetes ; Treatment intensification
Publicat a:	BMC family practice, Vol. 20 (february 2019) , ISSN 1471-2296

DOI: 10.1186/s12875-019-0916-9
PMID: 30732583

11 p, 659.5 KB

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