Interactive Virtual Assistance for Self-Care Management and Mental Health Promotion in Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 试验地点
- 2
- 主要终点
- Screening for depression, anxiety and common mental health disorders in elderly
研究概览
简要总结
BACKGROUD: Health technology is an important tool in the aging process, which may improve the health condition and self-esteem of the elderly, in addition to offering new opportunities and challenges. In this scenario, the use of virtual interaction systems emerge as promising alternatives for the old adults, which often deals with the lack of social interaction, cognitive decline and decline in functional capacity, making the control of chronic diseases, such as diabetes, a challenge.
OBJECTIVES: This project aims to evaluate the effectiveness of using an interactive virtual assistance system in mental health parameters, glycemic profile and diabetes selfcare behavior in elderly people with diabetes.
METHODS: A randomized clinical trial is proposed, for an intervention that includes 3 months of use of the Smart Speaker Echo Dot system, programmed to provide reminders, stimulate treatment records and maintain healthy habits. Outcomes assessed will include parameters of mental health and diabetes control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Being 65 years of age or older;
- •Having a diagnosis of type 2 diabetes;
- •Residing in Porto Alegre or metropolitan region;
- •Presenting availability of Wi-Fi connection at home; and
- •Presenting availability to participate in the proposed face-to-face evaluation and accept receiving one visit for installation of the device.
排除标准
- •Having an interactive virtual home assistance device at the time of enrollment;
- •Having cognitive impairments or severe hearing impairments that prevent adequate interaction with outcome assessors and the application of follow-up questionnaires; or
- •Residing in regions of difficult access.
- •Recruitment:
- •Study subjects will be recruited through two different strategies:
- •Screening of records of the outpatients clinics of Hospital São Lucas (HSL)
- •Social media advertising, specially in Instagram®
结局指标
主要结局
Screening for depression, anxiety and common mental health disorders in elderly
时间窗: Change from baseline to 12 weeks
For mental health screening, the Self Report Questionnaire (SRQ 20) will be used, translated into Portuguese and validated for the Brazilian population. It is a questionnaire with 20 questions specially developed for the screening of depression, anxiety em common mental health disorders in the elderly. Higher scores indicating more mental distress.
次要结局
- Variation in diastolic blood pressure(Change from baseline to 12 weeks)
- Variation in systolic blood pressure(Change from baseline to 12 weeks)
- Adherence parameters and self-care in the treatment of diabetes(Change from baseline to 12 weeks)
- Perception of stress:(Change from baseline to 12 weeks)
- Glycemic control: glycated hemoglobin (HbA1c) assessment(Change from baseline to 12 weeks)
- Variation in total cholesterol(Change from baseline to 12 weeks)
- Evaluation of quality of life(Change from baseline to 12 weeks)