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Background: Complications arising from uncontrolled Type 2 Diabetes Mellitus (T2DM) pose a significant burden on individuals' well-being and healthcare resources. Digital interventions may play a key role in mitigating such complications by supporting patients to adequately self-manage their condition., Aim: To assess the impact of DiabeText, a new theory-based, patient-centered, mobile health intervention integrated with electronic health records to send tailored short text messages to support T2DM self-management., Design and Setting: Pragmatic, Phase III, 12-month, two-arm randomized clinical trial with T2DM primary care patients in Spain., Method: 742 participants with suboptimal glycemic control (HbA1c>7.5) were randomly allocated to a control (usual care) or intervention (DiabeText) group. The DiabeText group received, in addition to usual care, 165 messages focused on healthy lifestyle and medication adherence., Primary Outcome: glycated hemoglobin (HbA1c)., Secondary Outcomes: medication possession ratio, quality of life (EQ-5D-5L), diabetes self-efficacy (DSES); and self-reported adherence to medication, Mediterranean diet (MEDAS-14), and physical activity (IPAQ)., Results: Over the 12-month period, we observed no significant differences in HbA1c between the intervention and the control groups (Beta=-0.025 (-0.198 to 0.147; p=0.772)). In comparison with the control group, the DiabeText group showed significant (p<0.05) improvements in self-reported medication adherence (OR=1.4; 95%CI: 1.0 to 1.9), DSES (Cohen's d=0.35), and EQ5D-5L (Cohen's d=0.18) scores; but not in the rest of secondary outcomes., Conclusion: DiabeText successfully improved quality of life, diabetes self-management, and self-reported medication adherence in primary care patients with T2DM. Further research is needed to enhance its effects on physiological outcomes., (Copyright © 2024, The Authors.)

Aims: To assess the impact of the COVID-19 pandemic on the health condition of people ≥75 years of age and on their family caregivers in Spain., Design: Multicentric, mixed method concurrent study., Methods: This work, which will be conducted within the primary care setting in 11 administrative regions of Spain, will include three coordinated studies with different methodologies. The first is a population-based cohort study that will use real-life data to analyze the rates and evolution of health needs, care provision, and services utilization before, during, and after the pandemic. The second is a prospective cohort study with 18 months of follow-up that will evaluate the impact of COVID-19 disease on mortality, frailty, functional and cognitive capacity, and quality of life of the participants. Finally, the third will be a qualitative study with a critical social approach to understand and interpret the social, political, and economic dimensions associated with the use of health services during the pandemic. We have followed the SPIRIT Checklist to address trial protocol and related documents. This research is being funded by the Instituto de Salud Carlos III since 2021 and was approved by its ethics committee (June 2022)., Discussion: The study findings will reveal the long-term impact of the COVID-19 pandemic on the older adults and their caregivers. This information will serve policymakers to adapt health policies to the needs of this population in situations of maximum stress, such as that produced by the COVID-19 pandemic., Trial Registration: Identifier: NCT05249868 [ClinicalTrials.gov]., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest., (Copyright © 2024 Rico-Blazquez, Esteban-Sepúlveda, Sánchez-Ruano, Aritztegui-Echenique, Artigues-Barbera, Brito-Brito, Casado-Ramirez, Cidoncha-Moreno, Fabregat-Julve, Feria-Raposo, Hernandez-Pascual, Lozano-Hernández, Moreno-Casbas, Otones-Reyes, Palmar-Santos, Pedraz-Marcos, Romero-Rodriguez, Solé-Agustí, Taltavull-Aparicio, Vidal-Thomas, Gonzalez-Chorda and Cuidamos+75 Group.)

Aim: To evaluate the effectiveness of DiabeText, a low-intensity, multifaceted, mobile health (mHealth) intervention to support medication taking and lifestyle change targeted to people with type 2 diabetes (T2D)., Design: Phase III, 12-months, two-arm (1:1 allocation ratio), randomized parallel-group trial., Methods: We will recruit 740 adults with glycated hemoglobin (A1c) >8% (>64 mmol/mol) and with at least one prescription of a non-insulin antidiabetic drug. They will be allocated to a control (usual care) group or an intervention (DiabeText messaging intervention) group. The primary outcome measure will be A1c at 12 months follow-up. Secondary outcomes will include medication possession ratio and behavioral and psychological outcomes., Discussion: Recent trials suggest that digital health interventions can effectively support diabetes self-management improving T2D control and reducing important T2D complications. In Spain this type of interventions is understudied., Impact: This trial will strengthen the evidence base of the impact of mHealth interventions to support diabetes self-management. If effective, DiabeText may offer a low-cost and highly scalable strategy to improve health at the population level in a sustainable way., Trial Registration: ClinicalTrials.gov identifier NCT05006872; Official Title: Supporting People with Type 2 Diabetes in Effective Use of their Medicine Through a System Comprising Mobile Health Technology Integrated with Clinical Care., Competing Interests: Declaration of Competing Interest I.R.-C., R.Z.-C., M.A.F.-d., M.J.S.-R and E.G.G are owners and developers of the software DiabeText. The resting authors have no conflicts of interest to declare., (Copyright © 2023. Published by Elsevier Inc.)

Background: Antidiabetic medication is effective in preventing diabetes-related complications. However, 40% of type 2 diabetic patients do not adhere to their medication regimes adequately. Brief text messages represent a promising approach to support medication adherence. The aim of this study was to explore the perspectives of primary care professionals (PCPs) concerning the DiabeText intervention, a new text messaging intervention to be developed to support medication adherence in people with type 2 diabetes (T2D) in Mallorca, Spain., Methods: We conducted four focus groups ( n = 28) and eight semi-structured interviews with doctors and nurses. Data collection and analysis were carried out by researchers independently following Braun and Clark's methodology., Results: Three main themes were identified: (1) text messaging interventions have the potential to effectively support diabetes self-management; (2) involving PCPs in the intervention would facilitate its design and implementation; (3) obtaining evidence supporting the cost-effectiveness is a key prerequisite for large-scale implementation of the intervention. PCPs identified barriers and enablers of the design and implementation of the intervention and made suggestions about the content and format of the text messages., Conclusion: The DiabeText intervention is perceived as useful and acceptable by PCPs provided its cost-effectiveness.

Background: Type 2 Diabetes Mellitus (T2DM) is a long-term condition affecting around 10% of people worldwide. This study aimed to explore T2DM patients' views on DiabeText, a new text messaging intervention to be developed to support adherence to diabetes medication., Methods: A total of four focus groups were conducted with a purposive sample of people with T2DM (n = 34). The data were analysed by multiple researchers independently, and coded using thematic analysis., Results: There were two main themes that emerged: (1) "patients' perspectives on unmet needs for diabetes self-management", and (2) "acceptability and perceived utility of DiabeText". The patients identified a number of barriers for diabetes self-management, including lack of appropriate information and support with diet and physical activity. Support for medication-taking was not perceived as urgently needed, although several barriers were identified (eating outside, traveling, polymedication, dispensation at the pharmacy). The participants anticipated that the proposed intervention would present high levels of patient acceptability and perceived utility as long as its content addresses the barriers that were identified, and includes specific features (short and clear messages, and personalized information)., Conclusion: The proposed intervention has the potential to be well accepted and perceived as useful by T2DM patients who require support not only in terms of medication-taking, but more prominently of lifestyle behaviour.