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Not yet recruiting NCT06998290

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

No phase Interventional CHD - Congenital Heart Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Blue-Line home telemonitoring program.
Who it may be relevant to
Registry conditions: CHD - Congenital Heart Disease. Basic parameters: 0 months — 12 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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

Primary outcome measures

  • Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered [Time frame: between inclusion visit and the last protocol visit (month 12)]
  • Evaluation of the measurement devices: functional (yes/no) [Time frame: between inclusion visit and the last protocol visit (month 12)]
  • Evaluation of the telemonitoring platform (functional/ergonomic/reliable) [Time frame: between inclusion visit and the last protocol visit (month 12)]
  • Recruitment rate: number of participants out of number of eligible patients [Time frame: 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 [Time frame: between inclusion visit and the last protocol visit (month 12)]
  • Acceptability to parents: parent satisfaction questionnaire [Time frame: between inclusion visit and the last protocol visit (month 12)]
  • Acceptability to caregivers: caregiver satisfaction questionnaire [Time frame: between inclusion visit and the last protocol visit (month 12)]
Secondary outcome measures (12)
  • Events of interest [Time frame: between months 3 and 12]
  • Date of telemonitoring alert [Time frame: between months 3 and 12]
  • Severity level of alert (orange/red) [Time frame: between months 3 and 12]
  • Appropriateness of the alert (yes/no) [Time frame: between months 3 and 12]
  • Respect for the procedure to be followed following an alert by parents (yes/no) [Time frame: between months 3 and 12]
  • Appropriateness of medical management following the alert given the clinical situation (yes/no) [Time frame: between months 3 and 12]
  • Evolution of the height (cm) [Time frame: between months 2 and 12]
  • Evolution of the weight (kg) [Time frame: between months 2 and 12]
  • Evolution of oxygen saturation (SpO2, %) [Time frame: between months 2 and 12]
  • Evolution of the heart failure score (Ross classification) [Time frame: between months 2 and 12]
  • Life quality [Time frame: between months 2 and 12]
  • Parental anxiety [Time frame: between months 2 and 12]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

France · 2 centers
  • CHU de Montpellier - Hôpital Arnaud de Villeneuve — Montpellier
  • CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque — Pessac

Identifiers

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

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗