Clinical trial NCT04530292: Home Intervention and Social Precariousness in Childhood Diabetes
Official title: Evaluation of the Impact of a Home-based Intervention by a Pediatric Nurse to Prevent Diabetes Imbalance Within One Year of Its Discovery in Children Whose Parents Are in a Precarious Social Situation (PRECADIAB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Pediatric type-1 diabetes
Therapeutic education
Social precariousness
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 29
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: A pilot study of children whose families are in a precarious situation, who will benefit from a targeted at-home intervention by a pediatric nurse. Visits will be organized during the first, fourth and sixth months after the discovery of diabetes. The HbA1C measured 12 months after the diabetes diagnosis will be compared to the HbA1C obtained in an historical cohort that did not receive at-home therapeutic education.

Detailed description: The EPICES score is an individual indicator of precariousness associated with indicators of access to health care and indicators of health. For this score, 30 is considered as the precariousness threshold. It is collected during the follow-up of our cohort of diabetic children and the data is obtained from the parent accompanying the child.

In 2016, we found in this cohort that a context of precariousness was associated with a very poor result of glycated hemoglobin (HbA1C) (Lamaraud J et al., 2017). The imbalance of diabetes was detectable as early as one year after diagnosis and persisted despite additional educational interventions. Therapeutic education allows families in precarious situations to acquire, during the initial hospitalization, knowledge that meets the security objectives and is adapted to the care of their child. However, we have noticed that it can be difficult for some families to apply this knowledge when they are back in their home.

Thus, we are planning to set up a coordinated intervention by a pediatric nurse at the child's home to support the parents in the implementation of the theoretical knowledge acquired at the hospital.

Three home visits will be set up by a nurse during the first six months of the discovery of diabetes in the child. These visits will be organized during the first, fourth and sixth months after the discovery of diabetes and last about 2 hours each time. An additional visit may be set up according to the needs of families. The HbA1C measured 12 months after the diabetes diagnosis will be compared to the HbA1C obtained in an historical cohort that did not receive at-home therapeutic education.

Eligibility criteria: For the prospective group (strategy under study):

* 1 to 16 years old
* Diagnosis of type 1 diabetes (T1D)
* EPICES score \> 30 (if separated parents, highest score)
* Hospitalized at the discovery of T1D in the pediatric diabetology unit of Bordeaux University Hospital
* Parents affiliated to social security
* Living in Gironde
* Consent of the parents or the holders of parental authority for the participation of their child
* Assent of the child

For the retrospective group (classic strategy):

* 1 to 16 years old at diabetes diagnosis
* Diagnosis of type 1 diabetes (T1D) from 1 January 2017 until the start of the study inclusion period
* EPICES score \> 30 (if separated parents, highest score)
* Hospitalized to the discovery of T1D and followed by the pediatric diabetology unit of Bordeaux University Hospital
* Parents affiliated to social security
* Living in Gironde
* For patients who are minor at the time of the study: whose parents or holders of the parental authority have received an individual information and are not opposed to the use of their data (EPICES score and their child's clinical data).

For minors who became adults at the time of the study: having received individual information and are not opposed to the use of the data necessary for the study (EPICES score and their clinical data).

Exclusion criteria:

For the prospective group (strategy under study):

* Absence of the therapeutic education nurse during the child's hospitalization
* Child and/or family who do not speak French
* Family benefiting from the PASS
* Intention of leaving the Gironde department in the first six months of the study
* T1D with associated chronic pathological conditions other than hypothyroidism and celiac disease

For the retrospective group (classic strategy):

* Child and/or family who do not speak French
* Family benefiting from the PASS
* T1D with associated chronic pathological conditions other than hypothyroidism and celiac disease

Primary outcomes:
measure: Measurement of HbA1c (%) one year after the discovery of diabetes.
timeFrame: 12 months after the diabetes diagnosis
Secondary outcomes:
measure: Number of visits actually carried out in the interventional arm
timeFrame: 12 months after the diabetes diagnosis
measure: Evaluation of the satisfaction with the intervention of the children and parents
timeFrame: 12 months after the diabetes diagnosis
measure: Evaluation of the satisfaction with the intervention of the pediatric endocrinology department's caregivers
timeFrame: 12 months after the diabetes diagnosis
measure: Evaluation of the satisfaction with the intervention of the external partners
timeFrame: 12 months after the diabetes diagnosis
measure: Unscheduled hospital visits in the context of T1D
timeFrame: Through study completion, 12 months after the diabetes diagnosis
measure: Percentage of time spent in the target for patients with Freestyle sensor
timeFrame: during the last month of the study, between 11 and 12 months after the diabetes diagnostic
measure: Percentage of time spent wearing the sensor for patients with Freestyle sensor
timeFrame: during the last month of the study, between 11 and 12 months after the diabetes diagnostic
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Magali GIMENEZ
role: PRINCIPAL_INVESTIGATOR
References: