远程医疗居家管理在慢性心力衰竭合并 II 型糖尿病患者中的应用：一项随机对照试验的研究方案。

Telemedicine home-based management in patients with chronic heart failure and diabetes type II: study protocol for a randomized controlled trial.

机构信息

Continuity of Care Service, Istituti Clinici Scientifici Maugeri IRCCS, Institute of Lumezzane, Via G. Mazzini 129, 25065, Lumezzane, Brescia, Italy.

Department of Cardiac Rehabilitation, Bolognini Hospital, Azienda Socio-Sanitaria Territoriale Bergamo Est, Seriate, Bergamo, Italy.

出版信息

Trials. 2024 May 21;25(1):333. doi: 10.1186/s13063-024-08171-0.

DOI:10.1186/s13063-024-08171-0

PMID:38773662

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11106884/

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 AND ANALYSIS

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.

DISCUSSION

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.

TRIAL REGISTRATION

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。这些复杂的慢性疾病需要广泛的药物治疗、持续的自我护理和行为改变。尽管已知生活方式改变（如定期运动和更好地控制血糖水平）有好处，但患者可能需要帮助来实施建议的改变。本研究旨在评估家庭远程医疗计划管理心力衰竭和 2 型糖尿病的效果。该计划侧重于促进生活方式改变。

方法和分析

在定期的门诊心脏病评估期间，符合条件的患者被招募并以 1:1 的比例随机分配到干预组或对照组。干预组通过结构化的家庭远程辅助计划和日常体力活动刺激培训师获得护理个案经理的支持。他们还可以根据需要进行与心脏病专家和糖尿病专家的远程咨询、生命体征远程监测以及日常步数跟踪。应用程序记录和监测每日药物治疗、血糖、血压、心率和其他临床参数。患者还可以通过聊天和视频会议系统向护理个案经理自行报告症状。对照组接受常规护理。数据采集在干预前和基线后 6 个月的新门诊心脏病评估期间进行。主要结局是测量 6 分钟步行测试中基线和 6 个月后行走距离的差异。关键次要结局包括改善疾病状况和身体活动状况。数据将根据意向治疗原则进行分析。