The TELE-DD Randomised Controlled Trial on Treatment Adherence in Patients with Type 2 Diabetes and Comorbid Depression: Clinical Outcomes after 18-Month Follow-Up

María Luisa Lozano del Hoyo, María Teresa Fernandez Rodrigo (), Fernando Urcola-Pardo, Alicia Monreal-Bartolomé, Diana Cecilia Gracia Ruiz, Mercedes Gómez Borao, Ana Belén Artigas Alcázar, José Pedro Martínez Casbas, Alexandra Aceituno Casas, María Teresa Andaluz Funcia and Juan Francisco Roy Delgado
Additional contact information
María Luisa Lozano del Hoyo: Las Fuentes Norte Health Centre, Servicio Aragonés de Salud (SALUD), 50002 Zaragoza, Spain
María Teresa Fernandez Rodrigo: Department of Physiatry and Nursing, Faculty of Health Sciences, University of Zaragoza, 50009 Zaragoza, Spain
Fernando Urcola-Pardo: Department of Physiatry and Nursing, Faculty of Health Sciences, University of Zaragoza, 50009 Zaragoza, Spain
Alicia Monreal-Bartolomé: Aragon Institute for Health Research (IIS Aragon), 50009 Zaragoza, Spain
Diana Cecilia Gracia Ruiz: Sagasta Health Center, Servicio Aragonés de Salud (SALUD), 50006 Zaragoza, Spain
Mercedes Gómez Borao: Sagasta Health Center, Servicio Aragonés de Salud (SALUD), 50006 Zaragoza, Spain
Ana Belén Artigas Alcázar: University Hospital Miguel Servet, Servicio Aragonés de Salud (SALUD), University of Zaragoza, 50009 Zaragoza, Spain
José Pedro Martínez Casbas: San Pablo Health Center, Servicio Aragonés de Salud (SALUD), 50003 Zaragoza, Spain
Alexandra Aceituno Casas: San Pablo Health Center, Servicio Aragonés de Salud (SALUD), 50003 Zaragoza, Spain
María Teresa Andaluz Funcia: San Pablo Health Center, Servicio Aragonés de Salud (SALUD), 50003 Zaragoza, Spain
Juan Francisco Roy Delgado: Faculty of Health Sciences, Universidad San Jorge, Villanueva de Gállego, 50830 Zaragoza, Spain

IJERPH, 2022, vol. 20, issue 1, 1-18

Abstract: 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.

Keywords: diabetes mellitus type 2; depressive disorder; diabetes distress; healthy lifestyle; motivational interviewing; primary care nursing; randomised controlled trial; self-management; telephonic intervention; treatment adherence (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2022
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