2026-04-26T23:37:00Zhttps://repisalud.isciii.es/rest/oai/request

oai:repisalud.isciii.es:20.500.12105/144882025-04-10T08:49:01Zcom_20.500.12105_2052com_20.500.12105_2051col_20.500.12105_19612

00925njm 22002777a 4500 dc Ramallo-Fariña, Yolanda author Rivero-Santana, Amado author García-Pérez, Lidia author García-Bello, Miguel Angel author Wägner, Ana Maria author González-Pacheco, Himar author Rodríguez-Rodríguez, Leticia author Kaiser-Girardot, Sybille author Monzón-Monzón, Guillermo author Guerra-Marrero, Carolina author Daranas-Aguilar, Carmen author Roldán-Ruano, Margarita author Carmona, Montserrat author Serrano-Aguilar, Pedro author INDICA Team author 2021-12-15 Objective: This study assesses the effectiveness of different interventions of knowledge transfer and behaviour modification to improve type 2 diabetes mellitus patients' (T2DM) reported outcomes measures (PROMs) in the long-term. Design: open, community-based pragmatic, multicentre, controlled trial with random allocation by clusters to usual care (UC) or to one of the three interventions. Participants: A total of 2334 patients with uncomplicated T2DM and 211 healthcare professionals were included of 32 primary care centres. Setting: Primary Care Centers in Canary Islands (Spain). Intervention: The intervention for patients (PTI) included an educational group programme, logs and a web-based platform for monitoring and automated short message service (SMS). The intervention for professionals (PFI) included an educational programme, a decision support tool embedded into the electronic clinical record and periodic feedback about patients' results. A third group received both PTI and PFI (combined intervention, CBI). Outcome measure: Cognitive-attitudinal, behavioural, affective and health-related quality of life (HQoL) variables. Results: Compared with UC at 24 months, the PTI group significantly improved knowledge (p=0.005), self-empowerment (p=0.002), adherence to dietary recommendations (p<0.001) and distress (p=0.01). The PFI group improved at 24 months in distress (p=0.03) and at 12 months there were improvements in depression (p=0.003), anxiety (p=0.05), HQoL (p=0.005) and self-empowerment (p<0.001). The CBI group improved at 24 months in self-empowerment (p=0.008) and adherence to dietary recommendations (p=0.004) and at 12 months in knowledge (p=0.008), depression (p=0.006), anxiety (p=0.003), distress (p=0.01), HQoL (p<0.001) and neuropathic symptoms (p=0.02). Statistically significant improvements were also observed at 24 months in the proportion of patients who quit smoking for PTI and CBI (41.5% in PTI and 42.3% in CBI vs 21.2% in the UC group). Conclusions: Assessed interventions to improve PROMs in T2DM attain effectiveness for knowledge, self-empowerment, distress, diet adherence and tobacco cessation. PTI produced the most lasting benefits. Trial registration number: ClinicalTrials.gov NCT01657227 (6 August 2012) https://clinicaltrials.gov/ct2/show/NCT01657227. BMJ Open. 2021 Dec 15;11(12):e050804. http://hdl.handle.net/20.500.12105/14488 34911711 10.1136/bmjopen-2021-050804 2044-6055 BMJ Open Diabetes & endocrinology Health informatics Primary care Quality in health care Patient-reported outcome measures for knowledge transfer and behaviour modification interventions in type 2 diabetes-the INDICA study: a multiarm cluster randomised controlled trial