Home Intervention and Social Precariousness in Childhood Diabetes

Diabetes Mellitus, Type 1 Clinical Trial

— PRECADIAB  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530292
• Other study ID #: CHUBX 2018/56
• Status: Completed
• Phase: N/A
• Start date: September 28, 2020
• Est. completion date: June 15, 2022

Study information

• Verified date: February 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 15, 2022
• Est. primary completion date: June 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Behavioral:
• Intervention by a pediatric nurse at the child's home
The intervention will consist of 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.

Locations

Country	Name	City	State
France	Chu Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of HbA1c (%) one year after the discovery of diabetes.	The Glycated hemoglobin (HbA1C) measured 12 months after the diabetes diagnosis	12 months after the diabetes diagnosis
Secondary	Number of visits actually carried out in the interventional arm	3 visits are planned but an additional visit may be set up according to the needs of families.; It is also possible that some visits cannot take place. The number of visits actually made will therefore be recorded.	12 months after the diabetes diagnosis
Secondary	Evaluation of the satisfaction with the intervention of the children and parents	Evaluation of the satisfaction with the intervention of the children and parents, measured with a standard visual analogue scale at the end of the intervention of the pediatric nurse	12 months after the diabetes diagnosis
Secondary	Evaluation of the satisfaction with the intervention of the pediatric endocrinology department's caregivers	Evaluation of the satisfaction of the pediatric endocrinology department's caregivers (pediatric diabetologists, nurses, dieticians) with the intervention, measured with a standard visual analogue scale at the end of the intervention of the pediatric nurse	12 months after the diabetes diagnosis
Secondary	Evaluation of the satisfaction with the intervention of the external partners	Evaluation of the satisfaction of the external partners (doctor or pediatrician, providers) with the intervention, measured with a standard visual analogue scale at the end of the intervention of the pediatric nurse	12 months after the diabetes diagnosis
Secondary	Unscheduled hospital visits in the context of T1D	Number of emergency visits and hospitalizations	Through study completion, 12 months after the diabetes diagnosis
Secondary	Percentage of time spent in the target for patients with Freestyle sensor	Percentage of time spent in the target (subcutaneous glucose measurement between 70 and 180 mg/dl) during the last month of the study for patients with Freestyle sensor	during the last month of the study, between 11 and 12 months after the diabetes diagnostic
Secondary	Percentage of time spent wearing the sensor for patients with Freestyle sensor	Percentage of time spent wearing the sensor during the last month of the study for patients with Freestyle sensor	during the last month of the study, between 11 and 12 months after the diabetes diagnostic