CHD - Congenital Heart Disease
Conditions
Keywords
Congenital heart disease, Infants, Vulnerability, Home monitoring, Therapeutic education, Digital platform
Brief summary
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
OTHERBlue-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
Sponsors
University Hospital, Bordeaux
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
0 Months to 12 Months
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the implementation of the patient therapeutic education programme: number of validated workshops out of number of workshops offered | between inclusion visit and the last protocol visit (month 12) | Contributes to programme feasibility criteria |
| Evaluation of the measurement devices: functional (yes/no) | between inclusion visit and the last protocol visit (month 12) | Contributes to programme feasibility criteria |
| Evaluation of the telemonitoring platform (functional/ergonomic/reliable) | 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 | 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 | between inclusion visit and the last protocol visit (month 12) | Contributes to programme feasibility criteria |
| Acceptability to parents: parent satisfaction questionnaire | between inclusion visit and the last protocol visit (month 12) | Contributes to programme feasibility criteria |
| Acceptability to caregivers: caregiver satisfaction questionnaire | between inclusion visit and the last protocol visit (month 12) | Contributes to programme feasibility criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evolution of the weight (kg) | between months 2 and 12 | Contributes to the clinical evolution criteria |
| Evolution of oxygen saturation (SpO2, %) | between months 2 and 12 | Contributes to the clinical evolution criteria |
| Events of interest | between months 3 and 12 | Events of interest are defined as any event leading to discontinuation of remote monitoring and/or unscheduled hospitalisation. |
| Life quality | between months 2 and 12 | Changes in the score of the QUALIN (QUALIté de vie du Nourrisson) validated generic quality of life proxy questionnaire: before returning home, at 3 months and at the end of the programme. The QUALIN questionnaire is a 34-item generic French QoL instrument designed for infants (aged 0-3 years). Each answer scores from -2 (totally false) to +2 (quite true). An item with a score \>1 corresponds to favourable QoL. |
| Parental anxiety | between months 2 and 12 | Changes in the score of the STAI (State-Trait Anwiety Inventory) parental anxiety questionnaire: state-trait anxiety inventory. The STAI questionnaire is a 40-item instrument designed for adults. Each answer score from 1 to 4. The higher the score, the less anxious the patient. |
| Evolution of the heart failure score (Ross classification) | between months 2 and 12 | Contributes to the clinical evolution criteria |
| Date of telemonitoring alert | between months 3 and 12 | Contributes to the alert performance criteria |
| Severity level of alert (orange/red) | between months 3 and 12 | Contributes to the alert performance criteria |
| Appropriateness of the alert (yes/no) | between months 3 and 12 | Contributes to the alert performance criteria |
| Respect for the procedure to be followed following an alert by parents (yes/no) | between months 3 and 12 | Contributes to the alert performance criteria |
| Appropriateness of medical management following the alert given the clinical situation (yes/no) | between months 3 and 12 | Contributes to the alert performance criteria |
| Evolution of the height (cm) | between months 2 and 12 | Contributes to the clinical evolution criteria |
Countries
France
Contacts
Primary ContactMélissa DACCORD
Backup ContactJulie CHABANEIX, MD
Outcome results
None listed