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

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 psychoed...

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Published in:International journal of environmental research and public health 2022-12, Vol.20 (1), p.328
Main Authors: Hoyo, María Luisa Lozano Del, Rodrigo, María Teresa Fernandez, Urcola-Pardo, Fernando, Monreal-Bartolomé, Alicia, Ruiz, Diana Cecilia Gracia, Borao, Mercedes Gómez, Alcázar, Ana Belén Artigas, Casbas, José Pedro Martínez, Casas, Alexandra Aceituno, Funcia, María Teresa Andaluz, Delgado, Juan Francisco Roy
Format: Article
Language:English
Subjects:
Activities of daily living
Adult
Blood pressure
Body mass
Body mass index
Body size
Cholesterol
Clinical outcomes
Cohort analysis
Comorbidity
Complications
Depression - complications
Depression - epidemiology
Depression - therapy
Diabetes
Diabetes mellitus
Diabetes mellitus (non-insulin dependent)
Diabetes Mellitus, Type 2 - complications
Diabetes Mellitus, Type 2 - epidemiology
Diabetes Mellitus, Type 2 - therapy
Disease
Follow-Up Studies
Glycated Hemoglobin
Health services
Humans
Intervention
Low density lipoprotein
Mental depression
Nurses
Patient compliance
Patients
Primary care
Prospective Studies
Quality of life
Telemedicine
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Summary: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. The TELE-DD project is a three-phased prospective study including a nested randomised controlled trial. 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. During the trial, 18-month follow-up HbA1C levels significantly ( < 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. 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. 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.
ISSN:1660-4601
1661-7827
1660-4601
DOI:10.3390/ijerph20010328