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| ID | Type | Description | Link |
|---|---|---|---|
| 2024-A01759-38 | Other Identifier | ID-RCB number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Blue-Line programme | Experimental | Telemonitoring program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blue-Line home telemonitoring program | Other |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | between inclusion visit and the last protocol visit (month 12) |
| Evaluation of the measurement devices: functional (yes/no) | Contributes to programme feasibility criteria | between inclusion visit and the last protocol visit (month 12) |
| Evaluation of the telemonitoring platform (functional/ergonomic/reliable) | Contributes to programme feasibility criteria | between inclusion visit and the last protocol visit (month 12) |
| Recruitment rate: number of participants out of number of eligible patients | Contributes to programme feasibility criteria | 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 | Contributes to programme feasibility criteria | between inclusion visit and the last protocol visit (month 12) |
| Acceptability to parents: parent satisfaction questionnaire | Contributes to programme feasibility criteria | between inclusion visit and the last protocol visit (month 12) |
| Acceptability to caregivers: caregiver satisfaction questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Events of interest | Events of interest are defined as any event leading to discontinuation of remote monitoring and/or unscheduled hospitalisation. | between months 3 and 12 |
| Date of telemonitoring alert |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mélissa DACCORD | Contact | +33 5 24 54 91 68 | +33 | melissa.daccord@chu-bordeaux.fr |
| Julie CHABANEIX, MD | Contact | +33 5 57 65 61 09 | +33 | julie.thomas@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Montpellier - Hôpital Arnaud de Villeneuve | Montpellier | France | 34295 - Cedex 5 | France |
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Contributes to programme feasibility criteria |
| between inclusion visit and the last protocol visit (month 12) |
Contributes to the alert performance criteria
| between months 3 and 12 |
| Severity level of alert (orange/red) | Contributes to the alert performance criteria | between months 3 and 12 |
| Appropriateness of the alert (yes/no) | Contributes to the alert performance criteria | between months 3 and 12 |
| Respect for the procedure to be followed following an alert by parents (yes/no) | Contributes to the alert performance criteria | between months 3 and 12 |
| Appropriateness of medical management following the alert given the clinical situation (yes/no) | Contributes to the alert performance criteria | between months 3 and 12 |
| Evolution of the height (cm) | Contributes to the clinical evolution criteria | between months 2 and 12 |
| Evolution of the weight (kg) | Contributes to the clinical evolution criteria | between months 2 and 12 |
| Evolution of oxygen saturation (SpO2, %) | Contributes to the clinical evolution criteria | between months 2 and 12 |
| Evolution of the heart failure score (Ross classification) | Contributes to the clinical evolution criteria | between months 2 and 12 |
| Life quality | 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. | between months 2 and 12 |
| Parental anxiety | 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. | between months 2 and 12 |
| CHU de Bordeaux - Hôpital Cardiologique Haut Lévêque | Pessac | France | 33604 | France |
|
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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