Telemedicine Home-based Management in Patients With Chronic Heart Failure and Type 2 Diabetes: a Randomized Control Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 4
- 主要终点
- Change in tolerance capacity
研究概览
简要总结
The progressive ageing of the population of industrialized countries is accompanied by a dramatic increase in the prevalence of chronic multi-pathologies. In the general population, HF is associated with a higher prevalence of T2DM compared with patients without HF and with marked regional differences observed in Europe and the rest of the world. In clinical trials of chronic HF patients, the prevalence of T2DM is approximately 30% in patients with reduced or preserved ejection fraction and rises to as much as 45% in hospitalized patient registries. A complex drug regimen is often associated with low adherence in patients with HF and T2DM and poor adherence is associated with adverse clinical events. Similarly, adherence to recommendations regarding lifestyle changes, such as increasing physical activity, is often limited despite these changes' favourable effects on the patient. Therefore, interventions are needed to improve all these factors and optimize adherence. The inclusion of telemedicine (telenursing, telerehabilitation, mHealth) focused on health and correct behaviour can create opportunities to implement customized and scalable solutions in populations at risk. The project will aim to evaluate for patients with chronic diseases with a complex phenotype (heart failure and type II diabetes mellitus) the effectiveness of a remote surveillance program with particular attention to lifestyle changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Consenting eligible patients were randomized to either an Intervention or a Control group (1:1).
A computer (www.randomization.com) generated tables to allocate patients in fixed blocks of four. In order to prevent selection bias, the list of randomization will be managed by personnel not directly involved in the enrolment of the patient. Due to the nature of the intervention, neither the patients nor the physicians were blinded to patients' group allocation. However, outcome assessors and data analysts will be blinded to the allocation.
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
- •Inform consent
- •Age ≥ 18 years
- •Documented diagnosis of heart failure, NYHA class II-III (reduced or preserved Ejection fraction without hospitalization in the last 3 months
- •Diagnosis of Diabetes Mellitus Type II in pharmacological treatment from at least one month
- •Ability to walk without assistive devices
- •Consent to using a device (independently or with the support of a caregiver) for recording the single electrocardiographic trace at home
- •Consent to using the App
排除标准
- •Subjects with poor collaboration
- •No possibility of using mobile technology
- •Life expectancy of fewer than 6 months
- •Medical issues that preclude participation in the program
结局指标
主要结局
Change in tolerance capacity
时间窗: Baseline and 6 months
The change from baseline in tolerance capacity will be measured by walking test performance (meters walked).
次要结局
- Change of hospitalizations(6 months)
- Number of Steps(Baseline and 6 months)
- HbA1c dosage(Baseline and 6 months)
- Change in quality of life related to Diabetes(Baseline and 6 months)
- Change in quality of life(Baseline and 6 months)
- Assessment of physical activity.(Baseline and 6 months)
- Change in quality of life related to heart failure(Baseline and 6 months)