PDF(Pubmed)
Abstract：
BACKGROUND: Heart failure and type 2 diabetes are prevalent public health issues in Europe. These complex chronic conditions require extensive pharmacological management, ongoing self-care, and behavioral changes. Despite the known benefits of lifestyle changes, such as regular exercise and better control of blood sugar levels, patients may need help implementing the recommended changes. This study aims to assess the effectiveness of a telemedicine program for managing heart failure and type 2 diabetes at home. The program focuses on promoting lifestyle changes.
METHODS: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles.
CONCLUSIONS: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early.
BACKGROUND: ClinicalTrials.gov NCT05633784. Registered on November 30, 2022.
METHODS: During scheduled outpatient cardiology evaluations, eligible patients are recruited and randomly assigned to either an intervention or control group in a 1:1 ratio. The intervention group receives support from a nursing case manager through a structured home-based teleassistance program and a trainer for daily physical activity stimulation. They also have access to teleconsultations with cardiologists and diabetes specialists as needed, telemonitoring of vital signs, and daily step tracking. An app records and monitors daily drug treatment, glycemia, blood pressure, heart rate, and other clinical parameters. Patients can also self-report symptoms and communicate via a chat and videoconference system with a Nurse Case Manager. The control group receives routine care. Data collection occurs before intervention and 6 months after baseline during a new outpatient cardiology evaluation. The primary outcome is to measure the difference in the distance walked during a 6-min walk test between baseline and after 6 months. The key secondary outcomes include improving the disease status and physical activity profile. Data will be analyzed according to the intention-to-treat principles.
CONCLUSIONS: This study will provide evidence on the efficacy of a telemedicine home-based management model to maintain correct lifestyles in patients with both heart failure and type 2 diabetes, improving self-management, their empowerment on the diseases, and increasing their knowledge and ability to recognize symptoms early.
BACKGROUND: ClinicalTrials.gov NCT05633784. Registered on November 30, 2022.
摘要：
背景：心力衰竭和2型糖尿病是欧洲普遍存在的公共卫生问题。这些复杂的慢性病需要广泛的药物管理，持续的自我照顾，和行为变化。尽管已知改变生活方式的好处，比如经常锻炼和更好地控制血糖水平，患者可能需要帮助实施建议的改变.这项研究旨在评估远程医疗计划在家中管理心力衰竭和2型糖尿病的有效性。该计划的重点是促进生活方式的改变。
方法：在定期门诊心脏病学评估期间，纳入符合条件的患者,并以1:1的比例随机分配至干预组或对照组.干预组通过结构化的基于家庭的远程治疗计划和日常体育锻炼刺激的培训师获得护理病例经理的支持。他们还可以根据需要与心脏病专家和糖尿病专家进行远程会诊，远程监测生命体征，和每日步数跟踪。一个应用程序记录和监控每日药物治疗，血糖，血压,心率,和其他临床参数。患者还可以自我报告症状，并通过聊天和视频会议系统与护士病例管理器进行交流。对照组接受常规护理。在新的门诊心脏病学评估期间，数据收集发生在干预前和基线后6个月。主要结果是测量基线和6个月后6分钟步行测试中步行距离的差异。关键的次要结果包括改善疾病状态和身体活动状况。数据将根据意向治疗原则进行分析。
结论：这项研究将为远程医疗家庭管理模式的有效性提供证据，以维持心力衰竭和2型糖尿病患者的正确生活方式。加强自我管理,他们对疾病的授权，并增加他们早期识别症状的知识和能力。
背景：ClinicalTrials.govNCT05633784。2022年11月30日注册。
方法：在定期门诊心脏病学评估期间，纳入符合条件的患者,并以1:1的比例随机分配至干预组或对照组.干预组通过结构化的基于家庭的远程治疗计划和日常体育锻炼刺激的培训师获得护理病例经理的支持。他们还可以根据需要与心脏病专家和糖尿病专家进行远程会诊，远程监测生命体征，和每日步数跟踪。一个应用程序记录和监控每日药物治疗，血糖，血压,心率,和其他临床参数。患者还可以自我报告症状，并通过聊天和视频会议系统与护士病例管理器进行交流。对照组接受常规护理。在新的门诊心脏病学评估期间，数据收集发生在干预前和基线后6个月。主要结果是测量基线和6个月后6分钟步行测试中步行距离的差异。关键的次要结果包括改善疾病状态和身体活动状况。数据将根据意向治疗原则进行分析。
结论：这项研究将为远程医疗家庭管理模式的有效性提供证据，以维持心力衰竭和2型糖尿病患者的正确生活方式。加强自我管理,他们对疾病的授权，并增加他们早期识别症状的知识和能力。
背景：ClinicalTrials.govNCT05633784。2022年11月30日注册。
