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临床试验/NCT01914588
NCT01914588已完成不适用

Effectiveness of a Multiparametric Telemonitoring System on Prevention of Hospital Admissions and Mortality In Elderly People With Chronic Heart Failure

Campus Bio-Medico University0 个研究点目标入组 100 人开始时间: 2012年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
主要终点
Hospital admissions or death

研究概览

简要总结

Heart failure is a chronic disease associated with an increasing risk of morbidity, disability, repeated hospitalizations and mortality. Telemedicine could promptly identify signs of worsening cardiac disease in order to improve elderly patients' home care and quality of life by reducing the need of hospital admissions and sanitary costs. The investigators present a randomized, parallel-group trial to test the ability of a multiparametric remote monitoring system, in addition to standard care, to promptly identify worsening of heart failure and prevent hospital admission and mortality.

详细描述

The participants were recruited in two settings:

  • Patients discharged with a first diagnosis of heart failure from the Geriatric Acute Care ward of a teaching hospital ("Policlinico Campus Bio-Medico", Rome, Italy);
  • Patients with a principal diagnosis of heart failure attending the outpatients clinic of the same hospital.

All the participants were evaluated at baseline and at the end of the study using a multi-dimensional assessment including well validated and routinely used tools to screen geriatric patients in order to detect global, physical and instrumental autonomy and consequent degree of dependence, as well as cognitive status. The assessment tool included: Activities of daily living scale (ADL) and Instrumental activities of daily living scale (IADL); Abbreviated mental Test; Geriatric Depression Scale; Physical Activity Scale for the Elderly; Six-minute walking test; The Short Form Health Survey (SF-12); Cumulative Illness Rating Scale (CIRS); complete list of drugs.

Once written consent form was obtained, participants were allocated to the study groups in a 1:1 ratio using a computer-generated random list of number.

Participants were followed up for six months. Patients in the intervention group were monitored via a system called PHEBO (Platform for High tech Evaluation of Biometrics Observation) that consisted of a commercial Android-based smartphone and a kit of measurement instruments (sphygmomanometer, pulse oximeter and an electronic scale) with a bluetooth transmitter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
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

入选标准

  • Patients with heart failure

排除标准

  • Cognitive impairment precluding the use of the experimental device

结局指标

主要结局

Hospital admissions or death

时间窗: Six months

Rate of hospital admissions for any reason or death

次要结局

  • Acute heart failure events(Six months)

研究者

发起方
Campus Bio-Medico University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raffaele Antonelli Incalzi

Director, Unit of Geriatrics

Campus Bio-Medico University

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