Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life

Официальное название

Feasibility of Home Telemonitoring of Infants With Congenital Heart Disease Awaiting Surgery During the First Year of Life: the Blue-Line Pilot Study

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое Blue-Line home telemonitoring program
  * A dedicated telemonitoring team with nurses and pediatric cardiologist * A dedicated therapeutic patient education programme * A home telemonitoring medical device with a dedicated platform

Первичные конечные точки

• Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered [Срок оценки: between inclusion visit and the last protocol visit (month 12)]
• Evaluation of the measurement devices: functional (yes/no) [Срок оценки: between inclusion visit and the last protocol visit (month 12)]
• Evaluation of the telemonitoring platform (functional/ergonomic/reliable) [Срок оценки: between inclusion visit and the last protocol visit (month 12)]
• Recruitment rate: number of participants out of number of eligible patients [Срок оценки: between inclusion visit and the last protocol visit (month 12)]
• Adherence to the telemonitoring programme: number of the participants who finish the programm out of number of patients included [Срок оценки: between inclusion visit and the last protocol visit (month 12)]
• Acceptability to parents: parent satisfaction questionnaire [Срок оценки: between inclusion visit and the last protocol visit (month 12)]
• Acceptability to caregivers: caregiver satisfaction questionnaire [Срок оценки: between inclusion visit and the last protocol visit (month 12)]

Вторичные конечные точки (12)

• Events of interest [Срок оценки: between months 3 and 12]
• Date of telemonitoring alert [Срок оценки: between months 3 and 12]
• Severity level of alert (orange/red) [Срок оценки: between months 3 and 12]
• Appropriateness of the alert (yes/no) [Срок оценки: between months 3 and 12]
• Respect for the procedure to be followed following an alert by parents (yes/no) [Срок оценки: between months 3 and 12]
• Appropriateness of medical management following the alert given the clinical situation (yes/no) [Срок оценки: between months 3 and 12]
• Evolution of the height (cm) [Срок оценки: between months 2 and 12]
• Evolution of the weight (kg) [Срок оценки: between months 2 and 12]
• Evolution of oxygen saturation (SpO2, %) [Срок оценки: between months 2 and 12]
• Evolution of the heart failure score (Ross classification) [Срок оценки: between months 2 and 12]
• Life quality [Срок оценки: between months 2 and 12]
• Parental anxiety [Срок оценки: between months 2 and 12]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Другое

Центры проведения

Франция · 2 центра

• CHU de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier
• CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque — Pessac

Идентификаторы

NCT: NCT06998290 · CHUBX 2021/41 · 2024-A01759-38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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