Post-Graduate Program in Medicine and Health Sciences, Pontifícia Universidade Católica Do Rio Grande Do Sul, Porto Alegre, Brazil.
Internal Medicine Division, Hospital São Lucas - Pontifícia Universidade Católica do Rio Grande do Sul, Porto Alegre, Brazil.
Trials. 2024 Mar 21;25(1):205. doi: 10.1186/s13063-024-08055-3.
With one in five individuals aged 65 or older living with type 2 diabetes worldwide, it is crucial to acknowledge and address the challenges faced by this population. In this context, our study aims to evaluate the efficacy of a behavioral intervention model delivered through a smart speaker on mental health and diabetes self-care in the elderly with diabetes.
This is a single-center, pragmatic, parallel two-arm open randomized clinical trial involving elderly patients with type 2 diabetes. We plan to enroll a total of 112 individuals who will be randomized 1:1 to receive the Smart Speaker EchoDot 3rd Gen device (Amazon Echo®) for home use (intervention arm) or to maintain usual care (control arm). The primary outcome is mental distress, assessed using the 20-item Self Reporting Questionnaire (SRQ-20) after a 12-week intervention period. Secondary outcomes include quality of life, adherence to diabetes self-care behaviors, perception of stress, glycemic control, blood pressure, and lipid profile. Analysis of covariance (ANCOVA) will be used to evaluate the effects of the intervention on the outcomes.
This study assesses the effectiveness of an interactive virtual assistance system for enhancing mental health and glycemic control among elderly individuals with type 2 diabetes. The findings may introduce smart speakers as a valuable tool for promoting diabetes-related self-care in this population.
ClinicalTrials.gov NCT05329376. Registered on 15 April 2022. Enrollment began on 20 June 2023 and the last update of protocol was on 13 December 2023.
全球有五分之一的 65 岁及以上老年人患有 2 型糖尿病，因此必须认识到并解决这一人群所面临的挑战。在这种情况下，我们的研究旨在评估通过智能音箱向老年糖尿病患者提供行为干预模式对心理健康和糖尿病自我护理的疗效。
这是一项单中心、实用、平行双臂开放随机临床试验，涉及老年 2 型糖尿病患者。我们计划共纳入 112 名患者，将他们 1:1 随机分配到使用智能音箱（亚马逊 Echo®）进行家庭使用（干预组）或维持常规护理（对照组）。主要结局是通过 12 周干预期后的 20 项自我报告问卷（SRQ-20）评估精神困扰。次要结局包括生活质量、糖尿病自我护理行为的依从性、压力感知、血糖控制、血压和血脂谱。将使用协方差分析（ANCOVA）评估干预对结局的影响。
本研究评估了交互式虚拟助手系统对增强老年 2 型糖尿病患者心理健康和血糖控制的有效性。研究结果可能会介绍智能音箱作为促进该人群糖尿病相关自我护理的有价值工具。
ClinicalTrials.gov NCT05329376。注册于 2022 年 4 月 15 日。入组于 2023 年 6 月 20 日开始，方案最后一次更新于 2023 年 12 月 13 日。
