Home Intervention and Social Precariousness in Childhood Diabetes

NCT04530292 | Completed

• 1 other identifier: CHUBX 2018/56
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Pediatric type-1 diabetes; Therapeutic education; Social precariousness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Number of visits actually carried out in the interventional arm

  12 months after the diabetes diagnosis

• Evaluation of the satisfaction with the intervention of the children and parents

  12 months after the diabetes diagnosis

• Evaluation of the satisfaction with the intervention of the pediatric endocrinology department's caregivers

  12 months after the diabetes diagnosis

• Evaluation of the satisfaction with the intervention of the external partners

  12 months after the diabetes diagnosis

• Unscheduled hospital visits in the context of T1D

  Through study completion, 12 months after the diabetes diagnosis

Study Arms (2)

intervention by a pediatric nurse at the child's home

EXPERIMENTAL

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.

Behavioral: Intervention by a pediatric nurse at the child's home

Classic strategy (for retrospective group)

NO INTERVENTION

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.

Interventions

Intervention by a pediatric nurse at the child's home 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.

Also known as: strategy under study ( for prospective group)

intervention by a pediatric nurse at the child's home

Eligibility Criteria

• Age: 1 Year - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Chu Bordeaux

Bordeaux, France

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Magali GIMENEZ

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 28, 2020
• Study Start: September 28, 2020
• Primary Completion: June 15, 2022
• Study Completion: June 15, 2022
• Last Updated: February 20, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)