French Version of the Scales of Fear of Hypoglycaemia in Children With Type 1 Diabetes and Their Parents (FHS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03529188|
Recruitment Status : Recruiting
First Posted : May 18, 2018
Last Update Posted : November 19, 2019
Type 1 diabetes usually appears brutally in children or young adults. While many factors of poor glycemic balance have been identified in the literature (age, socio-cultural and socio-economic level, family structure, adherence etc.), it turns out that hypoglycemia is the most common acute complications. It would be an important physiological and psychological barrier for the patient and his parents to manage this diabetes, the latter seeking to keep the blood glucose levels above the objectives in order to avoid the occurrence of a hypoglycemia, especially nocturnal.
If there is a questionnaire currently validated as a tool to measure the fear of hypoglycemia (HFS, Hypoglycemia Fear Survey is available in three versions: L'HFS-Child (HFS-C) for children over 6 years old, HFS-Parents of Young children ( HFS-PYC) for parents of young children (under 8 years of age) and HFS-Parents (HFS-P)) for parents of children over 8 years of age, on the other hand, there are no French and no French studies have evaluated the prevalence and impact of the fear of hypoglycemia in French patients with type 1 diabetes.
It is therefore essential to use a reliable and valid tool to identify patients affected by the fear of hypoglycemia, which can be an obstacle to improve glycemic control and to an optimum quality of life. Having a tool in French and validated on the scientific level would allow to propose adapted therapeutic treatments (psychological follow-up, individual or collective sessions of therapeutic education, material assistance (sensor of blood glucose, pump with insulin stop...) In order to both improve metabolic balance while increasing the quality of life of patients by lowering secondary anxiety to hypoglycemia
|Condition or disease|
|Diabetes Type 1|
|Study Type :||Observational|
|Estimated Enrollment :||210 participants|
|Official Title:||Validation of the French Version of the Three Scales for Assessing the Fear of Type 1 Hypoglycemia (HFS-C, HFS-PYC and HFS-P) in Children, Adolescents and Their Parents by a Monocentric Transverse Psychometric Study|
|Actual Study Start Date :||August 3, 2018|
|Estimated Primary Completion Date :||September 9, 2020|
|Estimated Study Completion Date :||September 9, 2020|
- HFS-Child score, [ Time Frame: Month 0 ]Change of Behaviour adopted by the patient in order to avoid the occurrence of hypoglycemia and worry about low blood sugar
- HFS-PYC score [ Time Frame: Month 0, Month 3 (+/- 30 days) ]Change in Anxiety related to the phenomenon of hypoglycemia
- HFS-Parent score [ Time Frame: Month 0, Month 3 (+/- 30 days) ]Change of Behaviour adopted by the parent in order to avoid the occurrence of hypoglycemia
- Questionnaire Survey "children " [ Time Frame: Month 0, Month 3 (+/- 30 days) ]Diabetes impact on relationships, activity, alimentation ... " children"
- Questionnaire Survey "parents " [ Time Frame: Month 0, Month 3 (+/- 30 days) ]Diabetes impact on relationships, activity, alimentation ... " parents"
- HbA1C [ Time Frame: Month 0, Month 3 (+/- 30 days) ]percentage value
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03529188
|Contact: Chantal METZ||02 29 02 00 email@example.com|
|Contact: Chantal METZfirstname.lastname@example.org|
|CHRU de Brest||Recruiting|
|Brest, France, 29609|
|Contact: Chantal METZ email@example.com|
|Centre Hospitalier de Bretagne Sud||Recruiting|
|Lorient, France, 56322|
|Contact: Raphaël TEISSIER firstname.lastname@example.org|
|Hôpital Universitaire Robert-Debré||Recruiting|
|Paris cedex 19, France, 75 935|
|Contact: Elise BISMUTH-REISMAN email@example.com|