NCT02486887Unknown不适用
Monitoring Electronique à Distance Des Patients Insuffisants Cardiaques
适应症
干预措施
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Number of rehospitalizations due to acute heart failure and number of death due to heart failure
研究概览
简要总结
The main objective of the study is to evaluate the effect of telemonitoring on mortality and rehospitalization due to heart failure on patients with chronic heart failure which have follow an educational program compared to a conventional follow-up during 1 year.
The secondary objectives of the study are :
- Evaluate the cost of health
- Qualitatively evaluate telemonitoring on uses
- Evaluate quality of life
详细描述
prospective, monocentric, randomized open-labeled study.
-
- Data collected
-
- during inclusion visit sex, age, full contact details, marital status, number of child, level of education, professional status weight, height, BMI, cardiac pulse, blood pressure, NYHA, consumption of tobacco and alcohol, concomitant treatments, medical history BNP, prealbumin Quality of life questionnaire (Minnesota), Depression questionnaire (HAD), autonomy questionnaire (IADL)
-
- at 6 month weight, height, BMI, cardiac pulse, blood pressure, NYHA, consumption of tobacco and alcohol, concomitant treatments, medical history BNP, prealbumin Number of consultations, nurses care, number of hospitalization in emergency care unit, number of hospitalization due to acute heart failure, number of days of hospitalization, number of medical transports Quality of life questionnaire (Minnesota), Depression questionnaire (HAD), autonomy questionnaire (IADL)
-
- at one year weight, height, BMI, cardiac pulse, blood pressure, NYHA, consumption of tobacco and alcohol, concomitant treatments, medical history BNP, prealbumin Number of consultations, nurses care, number of hospitalization in emergency care unit, number of hospitalization due to acute heart failure, number of days of hospitalization, number of medical transports Quality of life questionnaire (Minnesota), Depression questionnaire (HAD), autonomy questionnaire (IADL)
-
- Medico-economic evaluation The objective of this evaluation is to analyzed the efficiency of telemonitoring in patients with chronic heart failure.
This evaluation has to be :
- quantitative : directs modifications of cost and nature of health care follow-up or organization
- qualitative : indirect impact on health care costs of situations or behavior
-
- study of uses "uses" is faculty of recognition, comprehension, use, appropriation and diversion of the telemonitoring by patients.
During the first phase, interviews to obtain qualitative vision of interactions between telemonitoring and ecosystems of players.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic heart failure, NYHA II, III or IV
- •Patients with follow-up in therapeutic education program and who had finish the program in 2011, 2012, 2013, 2014, 2015, 2016, 2017
- •Information given and informed consent given
排除标准
- •vital emergencies
- •Refusal of patient, cardiologist or general practitioner
- •Person who is not able to communicate or answer the questions
- •Patients with problems of understanding as such dure to those diseases : dementia, Alzheimer disease, or neurological sequelae of cerebral stroke
- •Patients who do not speak french
- •Patients under guardianship
- •Patients with other diseases which alter quality of life
- •Patients who participate to another clinical trial
- •Person private of liberty by court decision
研究组 & 干预措施
telemonitoring
Experimental
telemonitoring of weight, arterial pressure and heart rate at home with connection to a medical platform to monitor the evolution.
干预措施: telemonitoring of weight, pulse and blood pressure (Device)
conventional follow-up
No Intervention
conventional follow-up
结局指标
主要结局
Number of rehospitalizations due to acute heart failure and number of death due to heart failure
时间窗: 1 year
次要结局
- Number and cost of consultations, treatments, hospitalization, transport, care of nurses ...(1 year)
- Qualitative interviews of patients and to all medical care services about uses and services rendered by the new device(1 year)
- Mean duration of stay during hospitalization(1 year)
- Scores on questionnaires of minnesota, EQ-5D and IADL to evaluate quality of life and autonomy(1 year)
- Interviews of patients and comptability of alarms of non-observance of weight, pulse and arterial pressure measure to evaluate acceptability and observance of telemonitoring device(1 year)
- Number of hospitalization in emergency care unit to measure efficacy of telemonitoring(1 year)
- Number of alarm for increase of weight, hypo- or hypertension, bradycardia or tachycardia as a measure of efficacy of telemonitoring(1 year)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Evaluation of a Remote Monitoring Application in the Follow-up of Patients With Active Inflammatory Bowel DiseasesUlcerative ColitisCrohn DiseaseNCT06742385Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives290
Unknown
不适用
Multidimensional Impact of Telemonitoring in Heart Failure (IMPACT-HF)Heart FailureNCT05653726Hospital Universitario 12 de Octubre390
招募中
不适用
Telemonitoring Platforms and Chemotherapy-Associated ToxicityChemotherapeutic Agent ToxicityCancerNCT06077123Universidad Nacional Andres Bello80
Unknown
不适用
Influence of Telemonitoring on the Management of LVAD-patientsVentricular Assist DeviceTelemedicineHeart FailureNCT04613401University Hospital, Essen50
已完成
不适用
Life-long Monitoring of Frail Patients With Chronic DiseasesMultiple Chronic Diseases Among Diabetes Mellitus, Chronic Obstructive Pulmonary Diseases and Heart FailureNCT01608932Regione Veneto152