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Diabetic patients have increased depression rates, diminished quality of life, and higher death rates due to depression comorbidity or diabetes complications. Treatment adherence (TA) and the maintenance of an adequate and competent self-care are crucial factors to reach optimal glycaemic control and stable quality of life in these patients. In this report, we present the baseline population analyses in phase I of the TELE-DD project, a three-phased population-based study in 23 Health Centres from the Aragonian Health Service Sector II in Zaragoza, Spain. The objectives of the present report are: (1) to determine the point prevalence of T2D and clinical depression comorbidity and treatment nonadherence; (2) to test if HbA1c and LDL-C, as primary DM outcomes, are related to TA in this population; and (3) to test if these DM primary outcomes are associated with TA independently of shared risk factors for DM and depression, and patients’ health behaviours. A population of 7,271 patients with type-2 diabetes and comorbid clinical depression was investigated for inclusion. Individuals with confirmed diagnoses and drug treatment for both illnesses (n = 3340) were included in the current phase I. A point prevalence of 1.9% was found for the T2D-depression comorbidity. The prevalence of patients nonadherent to treatment for these diseases was 35.4%. Multivariate analyses confirmed that lower diabetes duration, increased yearly PCS visits, HbA1c and LDL-C levels were independently related to treatment nonadherence. These findings informed the development of a telephonic monitoring platform for treatment of nonadherence for people with diabetes and comorbid depression and further trial, cost-effectiveness, and prognostic studies (phases II and III).

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Clinical depression is associated with poorer adherence to hypoglycaemic medication in patients with diabetes mellitus, leading to poorer glycaemic control, diabetes management, and increased complications. The main aim of the TELE-DD trial was to demonstrate the efficacy of a proactive and psychoeducational telephonic intervention based on motivational interviewing and collaborative care to reduce nonadherence and improve prognosis in individuals with diabetes mellitus and concurrent depression. Design: The TELE-DD project is a three-phased prospective study including a nested randomised controlled trial. Methods: The baseline cohort included the entire population of adult patients diagnosed with type 2 diabetes and concurrent depression. A randomised controlled trial was conducted in a selection of patients from the baseline cohort, distributed into a control group (n = 192) and an intervention group (n = 192). Monthly telephonic interventions delivered by specifically trained research nurses were centred on a psychoeducational individualised monitoring protocol including motivational interviewing and collaborative care strategies. Clinical and patient-centred data were systematically collected during an 18-month follow-up including HbA1c, Patient Health Questionnaire, and the Diabetes Distress Scale. Results: During the trial, 18-month follow-up HbA1C levels significantly (p < 0.001) decreased in the intervention group at every follow-up from an average of 8.72 (SD:1.49) to 7.03 (SD:1.09), but slightly increased in the control group from 8.65 (SD:1.40) to 8.84 (SD:1.38). Similar positive results were obtained in depression severity and diabetes distress, LDL-cholesterol, and systolic and diastolic blood pressure, but only at the 18-month follow-up in body mass index reduction. Conclusions: This is the first trial to concurrently decrease biological and psychological outcomes with a monthly brief telephonic intervention, pointing out that a combined biopsychosocial intervention and collaborative care strategy is essential for current world health challenges. ClinicalTrials.gov Identifier: NCT04097483. Patient or Public Contribution: Diabetic patients not belonging to the TELE-DD population or trial sample were consulted during the study design to review and guarantee the clarity and understanding of the trial psychoeducational materials.