Optimisation de la Surveillance Ambulatoire Des Insuffisants CArdiaques Par Télécardiologie (OSICAT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 990
- 试验地点
- 76
- 主要终点
- Number of All Causes Deaths and (Unplanned) Hospitalizations
研究概览
简要总结
Targeted population: Patients with heart failure causing hospitalization during the last twelve months.
Hypothesis: The number of all cause deaths and hospitalizations will be smaller for the Telecardiology group than for the reference group (standard follow-up care). An 18 months period of observation is required.
Main goal: To compare the rate of all cause deaths and hospitalizations of patients with heart failure between the Telecardiology group and the reference group after 18 months of monitoring.
详细描述
COMPARATIVE STUDY:
Comparative study of patients with chronic heart failure, randomized ratio (1:1), with two study arms (telecardiology vs usual care). French multicenter study.
The planned enrolment is 990 patients in a total period of 3.5 years. This study will involve an enrolment visit, managed by the recruiting investigator cardiologist, then four telephone contacts by Clinical Studies Technicians (CST). The purpose of the CST telephone contacts is to record the study data, and this will be occur for both study arms. Throughout the study, the patients in the telecardiology study arm will have regular contact with the Cordiva nurses for the management of their chronic heart failure, through telemonitoring and coaching. There is no planned hospitalization for the study.
Patients in the control group will receive the usual care: After enrolment, they will return home and will subsequently have regular visits to their General Practitioner (GP) or referring cardiologist.
Patients in the telecardiology group will receive the necessary monitoring equipment in their home in the week following their enrolment visit. This equipment includes a connected electronic scale and a questionnaire box. This questionnaire is designed to evaluate the evolution of patient symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
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
- •Aged 18 years or older
- •Men or women patient with heart failure having been hospitalized for cardiac decompensation during the last 12 months.
- •Patient with access to a wireline telephone service or GPRS network.
- •The patient is willing and able to sign an informed written consent
- •Patient is insured under the social security system
排除标准
- •No available echocardiographic evaluation.
- •BNP lower than 100pg/ml or NT-proBNP lower than 300pg/ml
- •A prognosis of a life span of less than 12 months (apart from heart failure)
- •Dialysis patients
- •Heart transplant or cardiac assist devices
- •Patients involved in inotropic treatment
- •Patient doesn't have the necessary autonomy to use the equipment
- •Patient enrolled in another clinical trial
- •A pregnant or nursing woman, or patient of reproductive age who doesn't use contraceptives
- •Patients under tutorship, curatorship or judicial protection
- •Inclusion Criteria in the extension period:
- •Participation in the open extension period is only offered to patients who participated in the comparative period of the study, did not withdraw prematurely from the latter and gave their free informed written consent to participate to the extension period.
结局指标
主要结局
Number of All Causes Deaths and (Unplanned) Hospitalizations
时间窗: 18 months
Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)
Number of All Causes Deaths and (Unplanned) Hospitalizations in Socially Isolated Patients
时间窗: 18 months
Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)
Number of All Causes Deaths and (Unplanned) Hospitalizations in NYHA Class III or IV Patients
时间窗: 18 months
Composite morbidity-mortality criterion combining the number of unplanned hospitalizations for any cause and deaths from any cause (adjudicated events)
次要结局
- Time to First Unplanned Hospital Readmission or Death From Any Cause(18 months)
- All Causes Deaths - Number of Patients Who Died From Any Cause(18 months)
- Number of Unplanned Hospitalizations for Any Cause(18 months)
- Number of Unplanned Hospitalizations for Heart Failure in NYHA Class III or IV Patients(18 months)
- Annualized Number of Unplanned Hospitalizations for Any Cause During the Extension Period(Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months))
- Number of Unplanned Hospitalizations for Heart Failure(18 months)
- Number of Unplanned Hospitalizations for Heart Failure in Socially Isolated Patients(18 months)
- Number of Patients Who Died From Cardiovascular Cause During the Extension Period(Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months))
- Number of Deaths and Unplanned Hospitalizations From Cardiovascular Cause(18 months)
- Time to Death From Any Cause(18 months)
- Time to First Unplanned Hospital Readmission for Heart Failure(18 months)
- Number of Patients Who Died From Any Cause During the Extension Period(Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months))
- Evolution of Quality of Life Assessed by Short Form-36 (SF-36) Questionnaire Scores(Between baseline and 12 months and between baseline and 18 months)
- Annualized Number of Unplanned Hospitalizations From Cardiovascular Cause During the Extension Period(Extension period until the marketing of the telemonitoring program (from 2 to 16 months, with an average of 9.5 months))