Home Intervention and Social Precariousness in Childhood Diabetes
- Conditions
- Diabetes Mellitus, Type 1
- Registration Number
- NCT04530292
- Lead Sponsor
- University Hospital, Bordeaux
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 29
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Measurement of HbA1c (%) one year after the discovery of diabetes. 12 months after the diabetes diagnosis The Glycated hemoglobin (HbA1C) measured 12 months after the diabetes diagnosis
- Secondary Outcome Measures
Name Time Method 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 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
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 children and parents, measured with a standard visual analogue scale at the end of the intervention of the pediatric nurse
Evaluation of the satisfaction with the intervention of the pediatric endocrinology department's caregivers 12 months after the diabetes diagnosis 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
Unscheduled hospital visits in the context of T1D Through study completion, 12 months after the diabetes diagnosis Number of emergency visits and hospitalizations
Number of visits actually carried out in the interventional arm 12 months after the diabetes diagnosis 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.Evaluation of the satisfaction with the intervention of the external partners 12 months after the diabetes diagnosis 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
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 Percentage of time spent wearing the sensor during the last month of the study for patients with Freestyle sensor
Trial Locations
- Locations (1)
Chu Bordeaux
🇫🇷Bordeaux, France
Chu Bordeaux🇫🇷Bordeaux, France