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Implementation Science
Published in: Implementation Science 1/2015

Open Access 01-12-2015 | Study protocol

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: 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

Published in: Implementation Science | Issue 1/2015

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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
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Metadata
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
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
Publication date
01-12-2015
Publisher
BioMed Central
Published in
Implementation Science / Issue 1/2015
Electronic ISSN: 1748-5908
DOI
https://doi.org/10.1186/s13012-015-0233-1

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