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Completed

NCT Number: NCT04530292

Home Intervention and Social Precariousness in Childhood Diabetes

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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Key information

Age range

1 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu Bordeaux

Bordeaux, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention by a pediatric nurse at the child's home

Behavioral

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)

Primary outcomes

  1. 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

  1. Number of visits actually carried out in the interventional arm

    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.

  2. Evaluation of the satisfaction with the intervention of the children and parents

    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

  3. Evaluation of the satisfaction with the intervention of the pediatric endocrinology department's caregivers

    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

  4. Evaluation of the satisfaction with the intervention of the external partners

    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

  5. Unscheduled hospital visits in the context of T1D

    Time frame: Through study completion, 12 months after the diabetes diagnosis

    Number of emergency visits and hospitalizations

  6. Percentage of time spent in the target 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 in the target (subcutaneous glucose measurement between 70 and 180 mg/dl) during the last month of the study for patients with Freestyle sensor

  7. Percentage of time spent wearing the sensor 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

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study 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)

Acronym: PRECADIAB

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 28, 2020
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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