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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age0-12
SponsorUniversity Hospital, Bordeaux

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.).

Trial design

Design model

Single group

Treatments tested in this trial

  • Blue-Line home telemonitoring program

    Other intervention

    * A dedicated telemonitoring team with nurses and pediatric cardiologist * A dedicated therapeutic patient education programme * A home telemonitoring medical device with a dedicated platform

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Blue-Line programmeExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered

Contributes to programme feasibility criteria

Time frame
between inclusion visit and the last protocol visit (month 12)
2

Evaluation of the measurement devices: functional (yes/no)

Contributes to programme feasibility criteria

Time frame
between inclusion visit and the last protocol visit (month 12)
3

Evaluation of the telemonitoring platform (functional/ergonomic/reliable)

Contributes to programme feasibility criteria

Time frame
between inclusion visit and the last protocol visit (month 12)
4

Recruitment rate: number of participants out of number of eligible patients

Contributes to programme feasibility criteria

Time frame
between inclusion visit and the last protocol visit (month 12)

Secondary outcomes

1

Events of interest

Events of interest are defined as any event leading to discontinuation of remote monitoring and/or unscheduled hospitalisation.

Time frame
between months 3 and 12
2

Date of telemonitoring alert

Contributes to the alert performance criteria

Time frame
between months 3 and 12
3

Severity level of alert (orange/red)

Contributes to the alert performance criteria

Time frame
between months 3 and 12
4

Appropriateness of the alert (yes/no)

Contributes to the alert performance criteria

Time frame
between months 3 and 12

Other outcomes

Sponsors and contacts

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