Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2017-A03021-52 | Other Identifier | ID-RCB number, ANSM |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this project is to assess the introduction of an individual follow-up distance coaching (phone and messages on a secure line platform) in order to optimize the health care of type 1 diabetes children with therapy adjustment difficulties. It is a personalized, multi-disciplinary, medical et paramedical. It will consist of an individual coaching for the children and families with therapy adjustment difficulties.
The hypothesis is that the proposed coaching would allow to improve the patient glycemic control not only during this coaching, but also, to bring long lasting improvement following the coaching.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care + coaching | Experimental | minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving individual coaching and usual standard care |
|
| Standard care | Sham Comparator | minor patients with a type 1 diabetes, having therapy adjustment difficulties, receiving usual standard care only. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| individual coaching | Other | coaching on the phone or with messages on line twice a month in order to help patients to adjust their insulin doses and fill in their self-assessment test. |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the rate of glycosylated hemoglobin after 6 months coaching (measure M6). | at 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between the rate of glycosylated hemoglobin (HbA1c) before randomization (baseline) and the follow-up. | at baseline, at 3 months, at 12 months | |
| Rate of patients presenting at least one bad accident (ketoacidosis and/or severe hypoglycemia) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Christine Lefe, MD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Jeanne de Flandres | Lille | France |
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard care | Other | completion of the self-assessment test at inclusion, at M6 and M12 for all study participants |
|
| at 6 months |
| Patient self-assessment score | at baseline, at 6 months, at 12 months |
| Capacity of proper adjustment of the treatment: binary variable " yes/no " evaluated to the judgment of the investigator | at baseline, at 6 months, at 12 months |
| Binary variable attendance = 80% honored appointments | at 6 months |