RENEWING HEALTH - Telemonitoring of Elderly and Frail Patients With Multiple Chronic Diseases in Veneto Region
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 7
- 主要终点
- Number of emergency hospitalisations
研究概览
简要总结
The purpose of this study is to evaluate whether telemonitoring of frail patients with chronic diseases produces benefits in terms of reduced readmissions, improved health related quality of life, and improved health status. In addition, the trial evaluates the economic and organisational impact of the telemonitoring service and examines its acceptability by patients and health professionals.
详细描述
The study is designed to evaluate the impact of telemonitoring on the follow-up of elderly patients with one or more chronic diseases among heart failure, chronic obstructive pulmonary disease and diabetes. The particular target of patients selected has the particularity of being "frail" according to a set of social eligibility criteria, agreed by the clinicians participating at the study. General practitioners are the first clinicians in charge of managing these patients during the trial follow-up. The term of comparison is represented by a control group, followed by outpatient usual care.
From a clinical point of view, the trial will investigate how the remote monitoring of some clinical parameters contributes to reduce the access to healthcare facilities (emergency and planned hospitalization, bed-days, ER, specialist and GP visits), to improve the patients health-related quality of life and to reduce the anxiety about health conditions. A cost-effectiveness and cost-utility analysis will be carried out in order to determine if and how telemonitoring helps to limit the healthcare expenditure. The evaluation will deal also with organizational changes and task shift due to telemonitoring introduction and patients and professionals perception towards the service.
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 65 years
- •Diagnosis of one or more of the following chronic diseases:
- •Heart failure - diagnosis confirmed by echocardiogram or by a specialist assessment
- •Type 1 or 2 diabetes - with HbA1C of 7.5 or greater in the previous 15 months
- •Chronic Obstructive Pulmonary Disease (COPD) - diagnosis confirmed by spirometry and FEV1 ≤ 70% of predicted normal and/or FEV1/FVC ratio ≤ 70% or by a specialist assessment
- •and at least one of the following Social inclusion criteria:
- •Have had a fall in the previous year or who are considered at high risk of falling
- •Need home social care
- •Have a caregiver who have difficulties to take care of him/her properly
- •Cognitive impairment/confusion, but with caregiver able to use devices.
排除标准
- •Patient unable to use the telemonitoring equipment (alone and assisted)
结局指标
主要结局
Number of emergency hospitalisations
时间窗: 12 months
次要结局
- Number of primary care visits.(12 months)
- Health related quality of life as measured by the SF 36 version 2 questionnaire(12 months)
- All cause mortality(12 months)
- Number of visits to emergency department(12 months)
- Number of elective hospital admissions(12 months)
- Number of bed days for hospitalised patients(12 months)
- Anxiety and depression status as measured by Hospital Anxiety and Depression Scale, HADS.(12 months)