SCIENTIFIC SESSION

INDICA is an open-label, pragmatic, multicentre clinical trial with cluster randomisation applied to basic health zones. Each of the 32 participating basic health zones was assigned to four possible branches: intervention for patients, intervention for professionals, intervention for both, and usual care. A total of 160 healthcare professionals and 2,334 patients with diabetes were included who, at the time of inclusion in the study, had no serious complications. The multicomponent intervention for patients included:

1. A group educational programme
2. A paper and web diary for continuous monitoring
3. Receipt of SMS messages promoting changes in their lifestyle based on the records that patients provided via the website.

The intervention for professionals included:

1. A group educational intervention to encourage shared decision-making and a decision-support tool integrated into the electronic health record for use during consultations
2.  A monthly summary of the comparative progress of their patients using indicators. During follow-up throughout the intervention (two years), modest effects of the intervention with patients were observed, both in laboratory parameters (glycated haemoglobin) and in BMI, as well as in patient-reported outcome measures (knowledge about diabetes, empowerment, adherence to the Mediterranean diet and diabetes-related distress).

Patients whose healthcare professionals received the intervention also showed effects on various patient-reported measures (empowerment, depression, anxiety and quality of life), and on blood pressure. Overall, these effects reached their maximum impact at 6 months into the intervention, and the effect gradually diminished over the course of the two years. It was hypothesised that the combination of these effects achieved could translate into a reduction in the risk of diabetes-associated microvascular and macrovascular complications during follow-up, as well as a reduction in mortality. Using the electronic records of the Canary Islands Health Service, INDICA-DOS carried out long-term follow-up of the patients (5 years). In addition, telephone follow-up was carried out in order to observe the long-term effect on patient-reported outcomes. Overall, despite the clinically relevant effect achieved in the first months of the intervention, at the five-year follow-up no lower morbidity or mortality was observed, nor were any relevant effects observed on patient-reported outcomes.