NCT02803489终止不适用
Evaluation of the Performance of an e-Health System Comprising Tele-monitoring / Tele-notification and Tele-coaching in Ambulatory Multi-morbid Adult Patients
Air Liquide Santé International8 个研究点 分布在 1 个国家目标入组 23 人开始时间: 2016年4月8日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 23
- 试验地点
- 8
- 主要终点
- Sensitivity and specificity of the tele-notifications
研究概览
简要总结
Prospective, non-randomized, open-label, pilot study conducted in a single group of 30 evaluable patients, i.e. patients completing an approximate 3 month follow-up.
详细描述
The eHealth system developed in the present study is dedicated to multimorbid patients' follow-up. The medical device consists in Telemonitoring, Telenotification and Telecoaching. It aims to both increase patient autonomy, with regard to management of his/her pathologies, and facilitate coordination between health professionals.
By providing patients with tools enabling early detection of clinical worsening combined with an appropriate management, the medium and long-term objectives are to reduce hospitalizations and improve health status and quality of life of these patients at home.
In the first instance, the only objective of the present study is to evaluate the performance and feasibility of implementation of the device. This evaluation is based on a comparison between the telenotifications generated by the software and those calculated from the raw data captured by the software.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Patients presenting all the following characteristics are eligible for inclusion:
- •Adult (>18 yrs), male or female
- •Presenting at least two chronic diseases among the following three: chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD), diabetes
- •Having been hospitalized in the CHANGE or in any other medical care center (hospital or private clinic) for acute decompensation of CHF or exacerbation of COPD at least once during the 12 months prior to inclusion
- •Able to speak and understand French to a satisfactory standard
- •Having a phone land line
- •Capable of understanding and accepting the study constraints
- •Having signed a written informed consent after a full explanation of the study by the investigator prior to inclusion
排除标准
- •Patients presenting any one of the following characteristics are not eligible for inclusion:
- •Pregnant or breast-feeding woman
- •Institutionalized
- •Having a life expectancy of less than 3 months
- •Receiving or having received chemotherapy or radiotherapy for cancer within the past 6 months
- •Undergoing dialysis for chronic renal insufficiency
- •Presenting a condition likely to hamper accomplishment of the study procedures, such as chronic alcoholism, drug or solvent addiction, uncontrolled psychiatric disease or severe cognitive deficiency
- •Not covered by French Social Security
- •Participating or having participated in another interventional trial within the past 30 days
研究组 & 干预措施
medical device intervention
Experimental
干预措施: medical device intervention (Device)
结局指标
主要结局
Sensitivity and specificity of the tele-notifications
时间窗: through study completion, an average of 11 months
次要结局
- Acceptability of the system by patients: mean number of participation in virtual classroom session(through study completion, an average of 11 months)
- Acceptability of the system by patients: mean number of consultations of modules providing medical information(through study completion, an average of 11 months)
- Acceptability of the system by patients: cumulative time spent on consultations of modules providing medical information(through study completion, an average of 11 months)
- Acceptability of the system by patients: mean duration of phone contacts by type (planned, for notification management, incoming)(through study completion, an average of 11 months)
- Acceptability of the system by patients: mean number of phone contacts by type (planned, for notification management, incoming)(through study completion, an average of 11 months)
- Acceptability of the system by patients: comparison of real planned phone contacts versus theoretical(through study completion, an average of 11 months)
- Acceptability of the system by physicians: mean number of connections(through study completion, an average of 11 months)
- Acceptability of the system by physicians: mean duration of connections(through study completion, an average of 11 months)
- Feasibility of the intervention for technicians(through study completion, an average of 11 months)
- Feasibility of the intervention for nurses(through study completion, an average of 11 months)
- Technological performance indices of the system: failures in data transmission(through study completion, an average of 11 months)
- Technological performance indices of the system: inaccessibility(through study completion, an average of 11 months)
- Technological performance indices of the system: devices deficiencies(through study completion, an average of 11 months)
- Sensitivity and specificity of the STABILITY SYSTEM INDICATORS(through study completion, an average of 11 months)
- Specific self-administered questionnaires about Ease of Use/Usefulness/Satisfaction for each category of user(through study completion, an average of 11 months)
- Acceptability of the system by patients regarding transmission of measured parameters(through study completion, an average of 11 months)
- Acceptability of the system by patients: mean duration of participation in virtual classroom session(through study completion, an average of 11 months)
- Feasibility of the intervention for patients(through study completion, an average of 11 months)
- Frequency of tele-notifications per patient(through study completion, an average of 11 months)
- Patient care plan: number of changes implemented by investigators.(through study completion, an average of 11 months)
- Clinical events including medical consultations, hospitalizations and adverse events(through study completion, an average of 11 months)
- Number of tele-notification per patient(through study completion, an average of 11 months)
研究者
研究点 (8)
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