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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 
Carrillo Domínguez, Armando
Boronat Cortés, Mauro 
Vallejo Torres, Laura 
Estupiñán Ramírez, Marcos
Pedrianes Martín, Pablo Benito 
García-Puente, Ignacio 
Salinero-Fort, Miguel Ángel
Serrano-Aguilar, Pedro Guillermo
Pérez de la Rosa, Abraham
Figueroa, Águeda Caballero
Guerra Pérez, Alejandro
Pareja Ríos, Alicia
carrillo, Alicia Pérez
Sifre Perello, Andrés
Gutiérrez Pérez, Ángela Trinidad 
Pérez Cejas, Antonia Pilar
Cabrera de León, Antonio
García Quintana, Antonio
Herrera Domínguez, Bernardo Eusebio
Sedeño Pérez, Carlos
Martínez Alberto, Carlos
Ramírez Álamo, Carlos
Daranas Aguilar, Carmen
Guerra Marrero, Carolina
Lobos Soto, Cecilia
Padrón Pérez, Cristina
Sánchez Vega, Cristina
Alvarado Marte, Dácil
Hernández Obregón, Daniel
de la Cruz Paz, Dionisio
Hernández Correa, Dulce N.
Espinosa Pozuelo, Elsa
Florido Mayor, Elsa
Pinilla Domínguez, Engracia
Herrera García, Fátima
Bonilla Aguiar, Félix
Montón Álvarez, Fernando
Cabrera López, Francisco
Ferraz Jerónimo, José Francisco
Hernández Díaz, Francisco
Guerra de la Torre, Gloria
Muelas Martín, Gregorio
Monzón Monzón, Guillermo
Rizo Arregui, Guillermo
de la Rosa Merino, Héctor
Gómez de Segura, Ignacio Llorente
García Calcerrada, Isabel
Álvarez Pérez, Jacqueline
Aldunate Page, Jorge Federico
García Dopico, José Antonio
Alemán Sánchez, José Juan
Salamanca Hernández, José Miguel
Medina Santana, José Ramón
Báez Hernández, Juan Andrés
Pérez Valencia, Juan José
Burgazzoli Samper, Juan Luis
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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