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Clinical Trials/NCT04530292
NCT04530292
Completed
N/A

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)

University Hospital, Bordeaux1 site in 1 country29 target enrollmentSeptember 28, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Diabetes Mellitus, Type 1
Sponsor
University Hospital, Bordeaux
Enrollment
29
Locations
1
Primary Endpoint
Measurement of HbA1c (%) one year after the discovery of diabetes.
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2020
End Date
June 15, 2022
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital, Bordeaux
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Measurement of HbA1c (%) one year after the discovery of diabetes.

Time Frame: 12 months after the diabetes diagnosis

The Glycated hemoglobin (HbA1C) measured 12 months after the diabetes diagnosis

Secondary Outcomes

  • Percentage of time spent in the target for patients with Freestyle sensor(during the last month of the study, between 11 and 12 months after the diabetes diagnostic)
  • 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)
  • Unscheduled hospital visits in the context of T1D(Through study completion, 12 months after the diabetes diagnosis)
  • 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 external partners(12 months after the diabetes diagnosis)
  • Percentage of time spent wearing the sensor for patients with Freestyle sensor(during the last month of the study, between 11 and 12 months after the diabetes diagnostic)

Study Sites (1)

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