Development and Evaluation of a Digital Health Intervention to Prevent Type 2 Diabetes in Primary Care: The PREDIABETEXT Study Protocol for a Randomised Clinical Trial

Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, m...

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Detalles Bibliográficos
Autores: Galmes-Panades, Aina Maria, Angullo Martinez, Escarlata, Mira-Martínez, Sofía, Bennasar-Veny, Miquel, Zamanillo Campos, Rocío, Konieczna, Jadwiga, Jiménez-López, Rafael, Serrano-Ripoll, Maria Jesus, Fiol-deRoque, Maria Antonia, Miralles Xamena, Jerònia, Yáñez, Aina Maria, Romaguera, Dora, Vidal-Thomàs, Maria Clara, Llobera Cànaves, Joan, Garcia Toro, Mauro, Vicens Caldentey, Catalina, Gervilla Garcia, Elena, Oña, José Iván, Malih, Narges, Leiva, Alfonso, Bulilete, Oana, Montaño, Juan José, Gili, Margalida, Roca, Miquel, Ricci-Cabello, Ignacio, Gomez-Juanes, Rocío
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Conselleria de Salut i Consum del Govern de les Illes Balears
Repositorio:Docusalut
Idioma:inglés
OAI Identifier:oai:docusalut.com:20.500.13003/18612
Acceso en línea:https://hdl.handle.net/20.500.13003/18612
Access Level:acceso abierto
Palabra clave:Diabetes Mellitus, Type 2
Prediabetic State
Randomized Controlled Trials as Topic
Text Messaging
Humans
Life Style
Primary Health Care
Clinical Trials, Phase II as Topic
Ensayos Clínicos Fase II como Asunto
Humanos
Estado Prediabético
Estilo de Vida
Diabetes Mellitus Tipo 2
Atención Primaria de Salud
Ensayos Clínicos Controlados Aleatorios como Asunto
Envío de Mensajes de Texto
Descripción
Sumario:Type 2 diabetes mellitus (T2DM) is a highly prevalent disease associated with an increased risk of comorbidities, premature death, and health costs. Prediabetes is a stage of glucose alteration previous to T2DM, that can be reversed. The aim of the study is to develop and evaluate a low-intensity, multifaceted, digital intervention to prevent T2DM. The intervention comprises: (1) the use of mobile health technology to send tailored text messages promoting lifestyle changes to people at risk of T2DM and (2) the provision of online education to primary healthcare physicians and nurses about management of prediabetes. In stages 1-4 we will design, develop and pilot-test the intervention. In Stage 5 we will conduct a phase II, six-month, three-arm, cluster randomized, clinical trial with 42 primary care professionals and 420 patients at risk of T2DM. Patients will be allocated to a control group (usual care), intervention A (patient messaging intervention), or intervention B (patient messaging intervention plus online education to their primary healthcare professionals). The primary outcome will be glycated haemoglobin. All the procedures obtained ethical approval in June 2021 (CEI-IB Ref No: IB4495/21PI). Digital health interventions can effectively prevent T2DM and reduce important T2DM risk factors such as overweight or hypertension. In Spain, this type of intervention is understudied. Moreover, there is controversy regarding the type of digital health interventions that are more effective. Findings from this study may contribute to address T2DM prevention, through a low-cost and easily implementable intervention.

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