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

Lozano del Hoyo, María Luisa, (Universidad de Zaragoza) ; Fernández Rodrigo, María Teresa (Universidad de Zaragoza) ; Urcola Pardo, Fernando (Universidad de Zaragoza) ; Monreal Bartolomé, Alicia (Universidad de Zaragoza) ; Gracia Ruiz, Diana Cecilia ; Gómez Borao, Mercedes (Universidad de Zaragoza) ; Alcázar Artigas, Ana Belén ; Martínez Casbas, José Pedro (Universidad de Zaragoza) ; Aceituno Casas, Alexandra ; Andaluz Funcia, María Teresa ; Roy Delgado, Juan Francisco (Universidad de Zaragoza)

Resumen: 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.

Idioma: Inglés

DOI: 10.3390/ijerph20010328

Año: 2023

Publicado en: International journal of environmental research and public health 20, 1 (2023), 328 [18 pp]
ISSN: 1661-7827

Factor impacto CITESCORE: 7.3 - Health, Toxicology and Mutagenesis (Q1) - Public Health, Environmental and Occupational Health (Q1) - Pollution (Q2)

Factor impacto SCIMAGO: 0.808 - Health, Toxicology and Mutagenesis (Q2) - Public Health, Environmental and Occupational Health (Q2) - Pollution (Q2)

Financiación: info:eu-repo/grantAgreement/ES/DGA/B43-20R Grupo Agua y salud
Financiación: info:eu-repo/grantAgreement/ES/ISCIII-MECD-IISZ/FI17-00180

Tipo y forma: Article (Published version)

Área (Departamento): Área Enfermería (Dpto. Fisiatría y Enfermería)
Área (Departamento): Área Psicolog.Evolut.Educac (Dpto. Psicología y Sociología)