Chu Bordeaux
Bordeaux, France
NCT Number: NCT04530292
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.
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Notify Me1 year–16 year
All sexes
Interventional
Not applicable
Bordeaux, France
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
For the prospective group (strategy under study):
For the retrospective group (classic strategy):
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):
For the retrospective group (classic strategy):
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.
Other names: strategy under study ( for prospective group)
Time frame: 12 months after the diabetes diagnosis
The Glycated hemoglobin (HbA1C) measured 12 months after the diabetes diagnosis
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Through study completion, 12 months after the diabetes diagnosis
Number of emergency visits and hospitalizations
Time frame: 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
Time frame: 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
University Hospital, Bordeaux
Other
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)
Acronym: PRECADIAB
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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