Effectiveness of a comprehensive care protocol in patients with new diagnoses of type 2 diabetes mellitus and associated comorbidities in primary care: study protocol of a quasi-experimental trial

Carolina Lapena, Enriqueta Borràs, Clarisa Digon, Rosa Aznar, Jose Luis Del Val Garcia, Esmeralda Castelblanco, Ana Garaikoetxea, Vicencia Laguna, Carolina Lapena, Enriqueta Borràs, Clarisa Digon, Rosa Aznar, Jose Luis Del Val Garcia, Esmeralda Castelblanco, Ana Garaikoetxea, Vicencia Laguna

Abstract

Introduction: Type 2 diabetes mellitus (T2DM) is a highly prevalent chronic disease in the Spanish population. Typically, T2DM is associated with other chronic conditions. Intensive medication at the time of diagnosis has proven effective in reducing cardiovascular risk, improving glycaemic control and preventing T2DM complications. However, it has not yet been demonstrated that a comprehensive and intensive health education protocol at the time of diagnosis has the benefits described previously. Currently, there is great variability in the practices of primary care nurses regarding health education at the time of disease diagnosis.We aimed to evaluate the effectiveness of a systematic protocol with a comprehensive care programme in people with newly diagnosed T2DM with associated comorbidities.

Methods and analysis: A multicentre quasi-experimental design comparing a group of individuals taking part in the intervention (intervention group (IG)) with a similar group receiving standard diabetes care (comparison group (CG)) is planned. The intervention will take place during the 3 months after study enrolment. Data will be collected at baseline and at 3, 6 and 12 months. Ten primary care centres in Barcelona city will be selected for participation: 5 for the IG and 5 for the CG. The IG will include five structured individual visits postdiagnosis with the primary care nurse, during which aspects of diabetes education will be discussed with the patient and his/her family. The results will be measured in terms of health-related quality of life and the change in main outcomes (glycated haemoglobin and weight).

Ethics and dissemination: The study fully met the requirements of the Ethical Committee of Clinical Investigation of the IDIAP Jordi Gol (approval code: P13/118). Patients will be informed that their data are confidential, and they have the right to withdraw at any time without penalty. Dissemination will include publishing the findings in peer-reviewed journals and sharing our findings at scientific conferences.

Trial registration number: NCT03990857; Pre-results.

Keywords: comorbidities; comprehensive care; type 2 diabetes mellitus.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flowchart of the intervention study. DLP, dyslipidaemia; HT, hypertension; T2DM, type 2 diabetes mellitus.
Figure 2
Figure 2
Structured intensive intervention and data collection.

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