mHealth Technology to Optimize Mental Health in Chronic Patients During the COVID-19 Outbreak in Paraguay
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 138
- 试验地点
- 2
- 主要终点
- Change on Health-related Quality of Life
研究概览
简要总结
MejoraCare-Paraguay main objective is to test a mHealth solution (MejoraCare app) to be used for the education and empowerment of chronic patients (COPD, cancer, diabetes, heart disease. hypertension, etc.), and for supporting healthcare professionals to monitor and better understand patients' evolution during the COVID-19 outbreak (MejoraCare dashboard).
This mHealth solution is built upon the Adhera platform, which has already been validated in other therapeutic areas such as smoking cessation.
MejoraCare is expected to raise awareness, educate and empower chronic patients, promoting behavioral changes towards adhering to healthier lifestyles thus reducing the risk of COVID-19 infection while providing emotional regulation support aiming at improving their mental health, quality of life, and emotional well-being.
详细描述
MejoraCare-Paraguay main objective is to test an mHealth solution (MejoraCare app) to be used for the education and empowerment of chronic patients (COPD, cancer, diabetes, heart disease. hypertension, etc.), and for supporting healthcare professionals to monitor and better understand patients' evolution during the COVID-19 outbreak (MejoraCare dashboard).
This mHealth solution is built upon the Adhera platform, which has already been validated in other therapeutic areas such as smoking cessation.
Its objective is two-fold: on the one hand, MejoraCare will provide the target population with an educational resource to improve their self-efficacy and knowledge about the disease and, on the other hand, to provide them with tools for the regulation of stress, anxiety and negative emotions generated in this high-risk population due to the COVID-19 outbreak situation.
MejoraCare is expected to raise awareness, educate and empower chronic patients, promoting behavioral changes towards adhering to healthier lifestyles thus reducing the risk of COVID-19 infection, while providing emotional regulation support aiming at improving their mental health, quality of life, and emotional well-being.
Personalized health education embedded into MejoraCare app covers the following topics:
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Legal adults (18+)
- •Patients suffering from, at least, one chronic disease.
- •Patients owning an Android smartphone and internet connection
- •Patients with a minimum level of digital literacy (being able to send text messages)
- •Patients able to read and understand Spanish
- •Signs the informed consent
排除标准
- •Diagnosed with any mental disorder
- •Withdraws the consent to participate in the study
结局指标
主要结局
Change on Health-related Quality of Life
时间窗: Baseline, 1, and 3, 6 and 12 months
The Health-related Quality of Life will be measured through the EuroQoL-5D-3L questionnaire measures health related quality of life. The questionnaire consist of five dimensions: mobility, self care, ordinary activities, discomfort, and mood state related to anxiety and depression. Each item ranges form no problem to a lot of problems.
次要结局
- Satisfaction with the MejoraCare app(1 month)
- Change in Anxiety(Baseline, 1, 3, 6 and 12 months)
- MejoraCare app Usability(1 month)
- Change in Self-efficacy(Baseline, 1, 3, 6 and 12 months)
- Change in Depression(Baseline, 1, 3, 6 and 12 months)
- Change in Health Empowerment(Baseline, 1, 3, 6 and 12 months)
- Change in Coping with Stress(Baseline, 1, 3, 6 and 12 months)