Home Intervention and Social Precariousness in Childhood Diabetes

NCT ID: NCT04530292

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-28
• Study Completion Date: 2022-06-15

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intervention by a pediatric nurse at the child's home

The pediatric nurse will visit the patient's home 3 times during the first six months of the discovery of diabetes in children. 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 can be organized according to the needs of families.

The pediatric nurse will ensure the implementation of learning in terms of drug therapy (modality of insulin administration, adaptation of insulin doses) and diet, according to the knowledge acquired during the initial hospitalization. She will offer her help to the families to make a connection with the school and after-school activities of the child.

In addition to these visits, the child and his family will come to the hospital as part of the regular medical follow-up: consultations with the pediatric diabetologist at the 3rd and 6th month and at 1 year of the discovery of diabetes.

Group Type: EXPERIMENTAL

Intervention by a pediatric nurse at the child's home

Intervention Type: BEHAVIORAL

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.

Classic strategy (for retrospective group)

The child and his family benefited from a consultation with a pediatric nurse at 1 month of the discovery of T1D and had medical consultations with the pediatric diabetologist at the 3rd and 6th month and at 1 year of the discovery of diabetes. The data from this group were collected in a previous study (collection of retrospective data) for children whose parents were in a precarious social situation and whose management was traditional.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

strategy under study ( for prospective group)

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Bordeaux

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Magali GIMENEZ

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeaux

Locations

Chu Bordeaux

Bordeaux, , France

Countries

France

Other Identifiers

CHUBX 2018/56

Identifier Type: -

Identifier Source: org_study_id