Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life: the Blue-Line Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered
研究概览
简要总结
Actually, there is no telemonitoring program that includes newborns or infants with congenital heart disease awaiting cardiac intervention. This is a vulnerable period, prone to clinical complications, rehospitalization, parental stress, and requires monitoring with clinical and therapeutic optimization. The aim of the study is to assess the feasibility and acceptability of monitoring newborns and infants with congenital heart disease awaiting cardiac surgery using the Blue-Line home telemonitoring program.
详细描述
Today, congenital heart disease affects around 0.8% of births in France. One third of children diagnosed antenatally or postnatally with congenital heart disease will require surgical or percutaneous intervention within the first year of life. Actually, there is no telemonitoring program that includes newborns or infants with congenital heart disease awaiting cardiac intervention. This is a vulnerable period, prone to clinical complications, rehospitalization, parental stress, and requires monitoring with clinical and therapeutic optimization. Our research team at the M3C Network Reference Center aims to develop home telemonitoring for these patients, in order to innovate and optimize their care pathway.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 0 Months 至 12 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newborns and/or infants aged 0 to 12 months inclusive at the time of diagnosis.
- •With congenital heart disease as defined in the ICD-11 classification.
- •Waiting for an intervention by cardiac surgery or interventional catheterization.
- •Free, informed consent signed by the holder(s) of parental authority.
- •Person affiliated to or benefiting from a social security scheme.
排除标准
- •Short-term vital prognosis
- •Clinical situation identified at the M3C RCP that contraindicates a return home
- •Family situation identified at the M3C RCP as contra-indicating a return home
- •Extra-cardiac co-morbidities requiring hospitalisation independent of the heart disease (e.g. severe renal failure, neurological deficit, complex immune deficiency, etc.).
- •Limited understanding of parental authority holder(s) / caregivers (non-French speaking, hearing impaired, cognitive impairment or other)
- •Parents unable to give informed consent.
- •Minors with parental authority
研究组 & 干预措施
Blue-Line programme
Telemonitoring program
干预措施: Blue-Line home telemonitoring program (Other)
结局指标
主要结局
Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered
时间窗: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
Evaluation of the measurement devices: functional (yes/no)
时间窗: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
Evaluation of the telemonitoring platform (functional/ergonomic/reliable)
时间窗: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
Recruitment rate: number of participants out of number of eligible patients
时间窗: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
Adherence to the telemonitoring programme: number of the participants who finish the programm out of number of patients included
时间窗: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
Acceptability to parents: parent satisfaction questionnaire
时间窗: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
Acceptability to caregivers: caregiver satisfaction questionnaire
时间窗: between inclusion visit and the last protocol visit (month 12)
Contributes to programme feasibility criteria
次要结局
- Evolution of oxygen saturation (SpO2, %)(between months 2 and 12)
- Evolution of the heart failure score (Ross classification)(between months 2 and 12)
- Respect for the procedure to be followed following an alert by parents (yes/no)(between months 3 and 12)
- Appropriateness of medical management following the alert given the clinical situation (yes/no)(between months 3 and 12)
- Evolution of the height (cm)(between months 2 and 12)
- Evolution of the weight (kg)(between months 2 and 12)
- Parental anxiety(between months 2 and 12)
- Events of interest(between months 3 and 12)
- Date of telemonitoring alert(between months 3 and 12)
- Severity level of alert (orange/red)(between months 3 and 12)
- Appropriateness of the alert (yes/no)(between months 3 and 12)
- Life quality(between months 2 and 12)