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

Yolanda Ramallo-Fariña, Lidia García-Pérez, Iván Castilla-Rodríguez, Lilisbeth Perestelo-Pérez, Ana María Wägner, Pedro de Pablos-Velasco, Armando Carrillo Domínguez, Mauro Boronat Cortés, Laura Vallejo-Torres, Marcos Estupiñán Ramírez, Pablo Pedrianes Martín, Ignacio García-Puente, Miguel Ángel Salinero-Fort, Pedro Guillermo Serrano-Aguilar, INDICA team, Abraham Pérez de la Rosa, Águeda Caballero Figueroa, Alejandro Guerra Pérez, Alicia Pareja Ríos, Alicia Pérez carrillo, Andrés Sifre Perello, Ángela Trinidad Gutiérrez Pérez, Antonia Pilar Pérez Cejas, Antonio Cabrera de León, Antonio García Quintana, Bernardo Eusebio Herrera Domínguez, Carlos Sedeño Pérez, Carlos Martínez Alberto, Carlos Ramírez Álamo, Carmen Daranas Aguilar, Carolina Guerra Marrero, Cecilia Lobos Soto, Cristina Padrón Pérez, Cristina Sánchez Vega, Dácil Alvarado Martel, Daniel Hernández Obregón, Dionisio de la Cruz Paz, Dulce N Hernández Correa, Elsa Espinosa Pozuelo, Elsa Florido Mayor, Engracia Pinilla Domínguez, Fátima Herrera García, Félix Bonilla Aguiar, Fernando Montón Álvarez, Francisco Cabrera López, Jose Francisco Ferraz Jerónimo, Francisco Hernández Díaz, Gloria Guerra de la Torre, Gregorio Muelas Martín, Guillermo Monzón Monzón, Guillermo Rizo Arregui, Héctor de la Rosa Merino, Ignacio Llorente Gómez de Segura, Isabel García Calcerrada, Jacqueline Álvarez Pérez, Jorge Federico Aldunate, Jose Antonio García Dopico, José Juan Alemán Sánchez, José Miguel Salamanca Hernández, Jose Ramón Medina Santana, Juan Andrés Báez Hernández, Juan José Pérez Valencia, Juan Luis Burgazzoli Samper, Julia Charlotte Wiebe, Leopoldo Martín Martín, Leticia Rodríguez Rodríguez, Lluis Serra Majem, Luis Morcillo Herrera, Margarita Roldán Ruano, María del Mar Romero Fernández, María Inmaculada González Pérez, María Isabel Visuerte Morales, María Pino Afonso Medina, Marta Riaño Ruiz, Marta Tejera Santana, Mercedes Lorenzo Medina, Miguel Juan Mora García, Miguel Pico Picos, Mónica Belinchón Sánchez-Somoza, Nayra Pérez Delgado, Oliver Rivero Arias, Pilar Peláez Alba, Rafael Valcárcel López, Remedios Castro Sánchez, Rita Tristancho Ajamil, Roberto Martín Fernández, Rodrigo Abreu González, Rosa Borges Trujillo, Rosa María Suárez Díaz, Salvador Acosta González, Sybille Kaiser Girardot, Víctor Lorenzo Sellarés, Yolanda Ramallo-Fariña, Lidia García-Pérez, Iván Castilla-Rodríguez, Lilisbeth Perestelo-Pérez, Ana María Wägner, Pedro de Pablos-Velasco, Armando Carrillo Domínguez, Mauro Boronat Cortés, Laura Vallejo-Torres, Marcos Estupiñán Ramírez, Pablo Pedrianes Martín, Ignacio García-Puente, Miguel Ángel Salinero-Fort, Pedro Guillermo Serrano-Aguilar, INDICA team, Abraham Pérez de la Rosa, Águeda Caballero Figueroa, Alejandro Guerra Pérez, Alicia Pareja Ríos, Alicia Pérez carrillo, Andrés Sifre Perello, Ángela Trinidad Gutiérrez Pérez, Antonia Pilar Pérez Cejas, Antonio Cabrera de León, Antonio García Quintana, Bernardo Eusebio Herrera Domínguez, Carlos Sedeño Pérez, Carlos Martínez Alberto, Carlos Ramírez Álamo, Carmen Daranas Aguilar, Carolina Guerra Marrero, Cecilia Lobos Soto, Cristina Padrón Pérez, Cristina Sánchez Vega, Dácil Alvarado Martel, Daniel Hernández Obregón, Dionisio de la Cruz Paz, Dulce N Hernández Correa, Elsa Espinosa Pozuelo, Elsa Florido Mayor, Engracia Pinilla Domínguez, Fátima Herrera García, Félix Bonilla Aguiar, Fernando Montón Álvarez, Francisco Cabrera López, Jose Francisco Ferraz Jerónimo, Francisco Hernández Díaz, Gloria Guerra de la Torre, Gregorio Muelas Martín, Guillermo Monzón Monzón, Guillermo Rizo Arregui, Héctor de la Rosa Merino, Ignacio Llorente Gómez de Segura, Isabel García Calcerrada, Jacqueline Álvarez Pérez, Jorge Federico Aldunate, Jose Antonio García Dopico, José Juan Alemán Sánchez, José Miguel Salamanca Hernández, Jose Ramón Medina Santana, Juan Andrés Báez Hernández, Juan José Pérez Valencia, Juan Luis Burgazzoli Samper, Julia Charlotte Wiebe, Leopoldo Martín Martín, Leticia Rodríguez Rodríguez, Lluis Serra Majem, Luis Morcillo Herrera, Margarita Roldán Ruano, María del Mar Romero Fernández, María Inmaculada González Pérez, María Isabel Visuerte Morales, María Pino Afonso Medina, Marta Riaño Ruiz, Marta Tejera Santana, Mercedes Lorenzo Medina, Miguel Juan Mora García, Miguel Pico Picos, Mónica Belinchón Sánchez-Somoza, Nayra Pérez Delgado, Oliver Rivero Arias, Pilar Peláez Alba, Rafael Valcárcel López, Remedios Castro Sánchez, Rita Tristancho Ajamil, Roberto Martín Fernández, Rodrigo Abreu González, Rosa Borges Trujillo, Rosa María Suárez Díaz, Salvador Acosta González, Sybille Kaiser Girardot, Víctor Lorenzo Sellarés

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.

Trial registration: Clinical Trial.gov NCT01657227.

Figures

Figure 1
Figure 1
Recruitment according to intervention assignment.

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