Back to resultsHome Intervention and Social Precariousness in Childhood Diabetes (PRECADIAB)
Primary Purpose
Diabetes Mellitus, Type 1
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Intervention by a pediatric nurse at the child's home
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Pediatric type-1 diabetes, Therapeutic education, Social precariousness
Eligibility Criteria
For the prospective group (strategy under study):
- 1 to 16 years old
- Diagnosis of type 1 diabetes (T1D)
- EPICES score > 30 (if separated parents, highest score)
- Hospitalized at the discovery of T1D in the pediatric diabetology unit of Bordeaux University Hospital
- Parents affiliated to social security
- Living in Gironde
- Consent of the parents or the holders of parental authority for the participation of their child
- Assent of the child
For the retrospective group (classic strategy):
- 1 to 16 years old at diabetes diagnosis
- Diagnosis of type 1 diabetes (T1D) from 1 January 2017 until the start of the study inclusion period
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention by a pediatric nurse at the child's home
Classic strategy (for retrospective group)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Measurement of HbA1c (%) one year after the discovery of diabetes.
The Glycated hemoglobin (HbA1C) measured 12 months after the diabetes diagnosis
Secondary Outcome Measures
Number of visits actually carried out in the interventional arm
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 children and parents
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
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
Evaluation of the satisfaction with the intervention of the external partners
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
Unscheduled hospital visits in the context of T1D
Number of emergency visits and hospitalizations
Percentage of time spent in the target for patients with Freestyle sensor
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
Percentage of time spent wearing the sensor for patients with Freestyle sensor
Percentage of time spent wearing the sensor during the last month of the study for patients with Freestyle sensor
Full Information
NCT ID
NCT04530292
First Posted
August 24, 2020
Last Updated
August 24, 2020
Sponsor
University Hospital, Bordeaux
1. Study Identification
Unique Protocol Identification Number
NCT04530292
Brief Title
Home Intervention and Social Precariousness in Childhood Diabetes
Acronym
PRECADIAB
Official Title
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)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Anticipated)
Primary Completion Date
February 28, 2021 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Pediatric type-1 diabetes, Therapeutic education, Social precariousness
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention by a pediatric nurse at the child's home
Arm Type
Experimental
Arm Description
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.
Arm Title
Classic strategy (for retrospective group)
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Intervention by a pediatric nurse at the child's home
Other Intervention Name(s)
strategy under study ( for prospective group)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Measurement of HbA1c (%) one year after the discovery of diabetes.
Description
The Glycated hemoglobin (HbA1C) measured 12 months after the diabetes diagnosis
Time Frame
12 months after the diabetes diagnosis
Secondary Outcome Measure Information:
Title
Number of visits actually carried out in the interventional arm
Description
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
Title
Evaluation of the satisfaction with the intervention of the children and parents
Description
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
Title
Evaluation of the satisfaction with the intervention of the pediatric endocrinology department's caregivers
Description
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
Title
Evaluation of the satisfaction with the intervention of the external partners
Description
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
12 months after the diabetes diagnosis
Title
Unscheduled hospital visits in the context of T1D
Description
Number of emergency visits and hospitalizations
Time Frame
Through study completion, 12 months after the diabetes diagnosis
Title
Percentage of time spent in the target for patients with Freestyle sensor
Description
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
Title
Percentage of time spent wearing the sensor for patients with Freestyle sensor
Description
Percentage of time spent wearing the sensor 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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
For the prospective group (strategy under study):
1 to 16 years old
Diagnosis of type 1 diabetes (T1D)
EPICES score > 30 (if separated parents, highest score)
Hospitalized at the discovery of T1D in the pediatric diabetology unit of Bordeaux University Hospital
Parents affiliated to social security
Living in Gironde
Consent of the parents or the holders of parental authority for the participation of their child
Assent of the child
For the retrospective group (classic strategy):
1 to 16 years old at diabetes diagnosis
Diagnosis of type 1 diabetes (T1D) from 1 January 2017 until the start of the study inclusion period
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Magali GIMENEZ
Phone
0556795632
Email
magali.gimenez@chu-bordeaux.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Aurore CAPELLI, PhD
Phone
0557820877
Email
aurore.capelli@chu-bordeaux.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magali GIMENEZ
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
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Home Intervention and Social Precariousness in Childhood Diabetes
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