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.
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
  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.
  
  
  CONCLUSIONS
  This ongoing trial aims to set up the implementation of evidence-based programs in the clinical setting for chronic patients.
  
  
  BACKGROUND
  Clinical Trial.gov NCT01657227.
authors.affiliation: Fundación Canaria de Investigación Sanitaria (FUNCANIS), Tenerife, Spain. yramfar@sescs.es.|Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Tenerife, Spain. yramfar@sescs.es.|Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain. yramfar@sescs.es.|Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Tenerife, Spain. yramfar@sescs.es.
authors.forename: Yolanda
authors.initials: Y
authors.lastname: Ramallo-Fariña
authors.affiliation: Fundación Canaria de Investigación Sanitaria (FUNCANIS), Tenerife, Spain. lidia.garciaperez@sescs.es.|Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Tenerife, Spain. lidia.garciaperez@sescs.es.|Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain. lidia.garciaperez@sescs.es.|Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Tenerife, Spain. lidia.garciaperez@sescs.es.
authors.forename: Lidia
authors.initials: L
authors.lastname: García-Pérez
authors.affiliation: Fundación Canaria de Investigación Sanitaria (FUNCANIS), Tenerife, Spain. ivan.castillarodriguez@sescs.es.|Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Tenerife, Spain. ivan.castillarodriguez@sescs.es.|Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain. ivan.castillarodriguez@sescs.es.|Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Tenerife, Spain. ivan.castillarodriguez@sescs.es.
authors.forename: Iván
authors.initials: I
authors.lastname: Castilla-Rodríguez
authors.affiliation: Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Tenerife, Spain. lilisbeth.peresteloperez@sescs.es.|Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain. lilisbeth.peresteloperez@sescs.es.|Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Tenerife, Spain. lilisbeth.peresteloperez@sescs.es.
authors.forename: Lilisbeth
authors.initials: L
authors.lastname: Perestelo-Pérez
authors.affiliation: Dpto de endocrinología, Complejo Hospitalario Universitario Insular Materno-Infantil, Gran Canaria, Spain. ana.wagner@ulpgc.es.|Instituto de Investigaciones Biomédicas y Sanitarias, Universidad de Las Palmas de Gran Canaria, Gran Canaria, Spain. ana.wagner@ulpgc.es.
authors.forename: Ana María
authors.initials: AM
authors.lastname: Wägner
authors.affiliation: Instituto de Investigaciones Biomédicas y Sanitarias, Universidad de Las Palmas de Gran Canaria, Gran Canaria, Spain. ppabvel@gobiernodecanarias.org.|Dpto de endocrinología, Hospital Universitario Dr. Negrín, Gran Canaria, Gran Canaria, Spain. ppabvel@gobiernodecanarias.org.
authors.forename: Pedro
authors.initials: P
authors.lastname: de Pablos-Velasco
authors.affiliation: Dpto de endocrinología, Complejo Hospitalario Universitario Insular Materno-Infantil, Gran Canaria, Spain. acardom@gmail.com.|Instituto de Investigaciones Biomédicas y Sanitarias, Universidad de Las Palmas de Gran Canaria, Gran Canaria, Spain. acardom@gmail.com.
authors.forename: Armando Carrillo
authors.initials: AC
authors.lastname: Domínguez
authors.affiliation: Dpto de endocrinología, Complejo Hospitalario Universitario Insular Materno-Infantil, Gran Canaria, Spain. mborcor@yahoo.es.|Dpto de Ciencias Médicas y Quirúrgicas, Universidad de Las Palmas de Gran Canaria, Gran Canaria, Spain. mborcor@yahoo.es.
authors.forename: Mauro Boronat
authors.initials: MB
authors.lastname: Cortés
authors.affiliation: Dpto de Economía de las Instituciones, Estadística Económica y Econometría, Universidad de la Laguna, Tenerife, Spain. laura.vallejotorres@sescs.es.
authors.forename: Laura
authors.initials: L
authors.lastname: Vallejo-Torres
authors.affiliation: Programas asistenciales, Servicio Canario de la Salud, Gran Canaria, Spain. mestrams@gobiernodecanarias.org.
authors.forename: Marcos Estupiñán
authors.initials: ME
authors.lastname: Ramírez
authors.affiliation: Dpto de endocrinología, Hospital Universitario Dr. Negrín, Gran Canaria, Gran Canaria, Spain. ppedmar@yahoo.es.
authors.forename: Pablo Pedrianes
authors.initials: PP
authors.lastname: Martín
authors.affiliation: Dpto de endocrinología, Hospital Universitario Dr. Negrín, Gran Canaria, Gran Canaria, Spain. igarciapuente@hotmail.com.
authors.forename: Ignacio
authors.initials: I
authors.lastname: García-Puente
authors.affiliation: Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain. miguel.salinero@salud.madrid.org.|Gerencia Adjunta de Planificación y Calidad. Servicio Madrileño de Salud (SERMAS), Madrid, Spain. miguel.salinero@salud.madrid.org.
authors.forename: Miguel Ángel
authors.initials: MÁ
authors.lastname: Salinero-Fort
authors.affiliation: Servicio de Evaluación del Servicio Canario de la Salud (SESCS), Tenerife, Spain. pseragu@gobiernodecanarias.org.|Red de Investigación en Servicios de Salud en Enfermedades Crónicas (REDISSEC), Madrid, Spain. pseragu@gobiernodecanarias.org.|Centro de Investigaciones Biomédicas de Canarias (CIBICAN), Tenerife, Spain. pseragu@gobiernodecanarias.org.
authors.forename: Pedro Guillermo
authors.initials: PG
authors.lastname: Serrano-Aguilar
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001521:Behavior Therapy / Q000191:economics / Q000379:methods*; D040421:Cell Phone; D003362:Cost-Benefit Analysis; D003924:Diabetes Mellitus, Type 2 / Q000191:economics / Q000523:psychology / Q000628:therapy*; D005260:Female; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D008297:Male; D008875:Middle Aged; D010353:Patient Education as Topic / Q000191:economics / Q000379:methods*; D058007:Physicians, Primary Care / Q000193:education; D015397:Program Evaluation; D055815:Young Adult