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Title: Effectiveness and cost-effectiveness of knowledge transfer and behavior modification interventions in type 2 diabetes mellitus patients-the INDICA study: A cluster randomized controlled trial
Authors: Ramallo-Fariña, Yolanda
García-Pérez, Lidia
Castilla-Rodríguez, Iván
Perestelo-Pérez, Lilisbeth
Wägner, Ana María 
de Pablos-Velasco, Pedro 
Domínguez, Armando Carrillo
Cortés, Mauro Boronat
Vallejo-Torres, Laura
Ramírez, Marcos Estupiñán
Martín, Pablo Pedrianes
García-Puente, Ignacio 
Salinero-Fort, Miguel Ángel
Serrano-Aguilar, Pedro Guillermo
de la Rosa, Abraham Pérez
Figueroa, Águeda Caballero
Pérez, Alejandro Guerra
Ríos, Alicia Pareja
carrillo, Alicia Pérez
Perello, Andrés Sifre
Pérez, Ángela Trinidad Gutiérrez
Cejas, Antonia Pilar Pérez
de León, Antonio Cabrera
Quintana, Antonio García
Domínguez, Bernardo Eusebio Herrera
Pérez, Carlos Sedeño
Alberto, Carlos Martínez
álamo, Carlos Ramírez
Aguilar, Carmen Daranas
Marrero, Carolina Guerra
Soto, Cecilia Lobos
Pérez, Cristina Padrón
Vega, Cristina Sánchez
Marte, Dácil Alvarado
Obregón, Daniel Hernández
de la Cruz Paz, Dionisio
Correa, Dulce N.Hernández
Pozuelo, Elsa Espinosa
Mayor, Elsa Florido
Domínguez, Engracia Pinilla
García, Fátima Herrera
Aguiar, Félix Bonilla
álvarez, Fernando Montón
López, Francisco Cabrera
Jerónimo, Jose Francisco Ferraz
Díaz, Francisco Hernández
de la Torre, Gloria Guerra
Martín, Gregorio Muelas
Monzón, Guillermo Monzón
Arregui, Guillermo Rizo
de la Rosa Merino, Héctor
de Segura, Ignacio Llorente Gómez
Calcerrada, Isabel García
Pérez, Jacqueline álvarez
Page, Jorge Federico Aldunate
Dopico, Jose Antonio García
Sánchez, José Juan Alemán
Hernández, José Miguel Salamanca
Santana, Jose Ramón Medina
Hernández, Juan Andrés Báez
Valencia, Juan José Pérez
Samper, Juan Luis Burgazzoli
Wiebe, Julia Charlotte
UNESCO Clasification: 32 Ciencias médicas
Keywords: Decision-Support-Systems
Life-Style Intervention
Multifactorial Intervention
Health-Professionals, et al
Issue Date: 2015
Journal: Implementation Science 
Abstract: Background: Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals' decision-making. The Diabetes Intervention study in the Canary Islands (INDICA study) aims to evaluate the effectiveness and cost-effectiveness of educational interventions supported by new technology decision tools for type 2 diabetes patients and primary care professionals in the Canary Islands.Methods/design: The INDICA study is an open, community-based, multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care. The setting is primary care where physicians and nurses are invited to participate. Patients with diabetes diagnosis, 18-65 years of age, and regular users of mobile phone were randomly selected. Patients with severe comorbidities were excluded. The clusters are primary healthcare practices with enough professionals and available places to provide the intervention. The calculated sample size was 2,300 patients.Patients in group 1 are receiving an educational group program of eight sessions every 3 months led by trained nurses and monitored by means of logs and a web-based platform and tailored semi-automated SMS for continuous support. Primary care professionals in group 2 are receiving a short educational program to update their diabetes knowledge, which includes a decision support tool embedded into the electronic clinical record and a monthly feedback report of patients' results. Group 3 is receiving a combination of the interventions for patients and professionals. The primary endpoint is the change in HbA1c in 2 years. Secondary endpoints are cardiovascular risk factors, macrovascular and microvascular diabetes complications, quality of life, psychological outcomes, diabetes knowledge, and healthcare utilization. Data is being collected from interviews, questionnaires, clinical examinations, and records. Generalized linear mixed models with repeated time measurements will be used to analyze changes in outcomes. The cost-effectiveness analysis, from the healthcare services perspective, involves direct medical costs per quality-adjusted life year gained and two periods, a 'within-trial' period and a lifetime Markov model. Deterministic and probabilistic sensitivity analyses are planned.Discussion: This ongoing trial aims to set up the implementation of evidence-based programs in the clinical setting for chronic patients.
ISSN: 1748-5908
DOI: 10.1186/s13012-015-0233-1
Source: Implementation Science [ISSN 1748-5908] ,v. 10, (47), (Abril 2015)
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