Abstract
BackgroundType 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/designThe 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.DiscussionThis ongoing trial aims to set up the implementation of evidence-based programs in the clinical setting for chronic patients.Trial registrationClinical Trial.gov NCT01657227
Highlights
Type 2 diabetes mellitus is a chronic disease whose health outcomes are related to patients and healthcare professionals’ decision-making
The ongoing INDICA study is a four-arm randomized controlled trial (RCT) involving all main actors playing a role in decision-making in Type 2 diabetes mellitus (T2DM)
The INDICA study will assess the comparative effectiveness and cost-effectiveness of usual care for T2DM patients against three multicomponent education and coaching interventions. These interventions combine conventional group educational and training activities with different information and communication technology (ICT)-based interventions to guide the decisions of T2DM patients, families, and primary care healthcare professionals, according to evidence-based guidelines
Summary
The ongoing INDICA study is a four-arm RCT involving all main actors playing a role in decision-making in T2DM (patients, families, physician and nurses). The INDICA study will assess the comparative effectiveness and cost-effectiveness of usual care for T2DM patients against three multicomponent education and coaching interventions. Few previous studies of electronic communication interventions for T2DM are randomized, include a control group, or involve more than one treatment group to evaluate complex or multicomponent interventions for all actors involved, from the effectiveness perspective and the assessment of cost-effectiveness. This approach will improve transferability by extending the usefulness of the expected results beyond patients and clinicians in primary care to healthcare policy decision-makers.
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