Evaluation of an Early Screener to Identify Long-term Problems With Regard to Metabolic Control and Treatment Adherence Among Children and Adolescents With Type 1 Diabetes
- Conditions
- Type 1 Diabetes
- Registration Number
- NCT03642483
- Lead Sponsor
- University Children's Hospital, Zurich
- Brief Summary
Background: Type 1 diabetes is one of the most common chronic illnesses among children and adolescents. Although, intensive medical care is provided for these patients, some of them have poor metabolic control. For example, only 21% of adolescents with type 1 diabetes in the USA achieve the recommended average blood sugar concentration (HbA1c\<7.5%). This is a major problem, since chronic hyperglycemia is the primary cause of morbidity and mortality in type 1 diabetes and causes several serious complications, for example kidney failure, blindness, and stroke. Therefore, the International Society for Pediatric and Adolescent Diabetes (ISPAD) declared psychosocial factors, to be the most important risk factors of poor type 1 diabetes Management. Therefore, an instrument is needed to identify children and adolescents with poor metabolic control in their course of disease as soon as possible. With an early identification of such risk patients, better support can be provided. However, there is no such instrument yet for pediatric patients with type 1 diabetes. To fill this gap, a questionnaire (FEPB) based on the PAT 2.0© (Psychosocial Assessment Tool; an instrument used in oncology) was developed for this project.
Aim: The aim of this project is to evaluate and validate a new instrument (FEPB) for an early identification of children and adolescents with poor metabolic control in their course of disease in a longitudinal design.
Method: The sample consists of children and adolescents (age: 5-18 years), who were newly diagnosed with type 1 diabetes (2-4 weeks ago), and who are in care at the University Children's Hospital of Zurich. Structured interviews are conducted with the patients and the parents are asked to fill out some questionnaires at two times: first, 2-4 weeks after the diagnosis (T1) and second 6 month later (T2). With the new instrument (FEPB) a risk score can be calculated for each patient at T1. Statistical analysis will be performed to determine whether that risk score can predict which patients have poor metabolic control (HbA1c \> 7.5%) at T2.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 61
- diagnosed with type 1 Diabetes 2-4 weeks ago
- in care at the University Children's Hospital of Zurich
- German speaking
- other severe illness that affects the diabetes Management
- severe developmental disorder
- pregnancy
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method HbA1c 10 minutes Glycated hemoglobin
- Secondary Outcome Measures
Name Time Method health-related quality of life (Chronic generic measure) 5 minutes Assessed by questionnaire: DISABKIDS Chronic generic measure - short version (DCGM-12; the European DISABKIDS Group, 2012).
Total score range: 12-60. The higher the score, the higher the health-related quality of life.health-related quality of life (diabetes module) 5 minutes Assessed by questionnaire: DISABKIDS diabetes module (The European DISABKIDS Group, 2012).
Total score range: 10-50. The higher the score, the higher the health-related quality of life.psychological health (Trait-Anxiety) 5 minutes Assessed by questionnaire: German Version of the Trait-Anxiety Inventory for Children (Trait Angstinventar für Kinder \[STAIK-T\]; Unnewehr, Joormann, Schneider \& Margraf, 1992).
Total score range: 20-60. The higher the score, the higher the trait anxiety.psychological health (Child Behavior) 10 minutes Assessed by questionnaire: German Version of the Child Behavior Checklist (CBCL 6-18R; Döpfner, Plück \& Kinnen, 2014) Total score range: 0-224. The higher the score, the more behavioral problems.
psychological health (Depression) 10 minutes Assessed by questionnaire: German Version of the Children's Depression Inventory (Depressionsinventar für Kinder und Jugendliche \[DIKJ\]; Stiensmeier-Pelster, Braune-Krickau, Schürmann \& Duda, 2014).
Total score range: 0-58. The higher the score, the more depressed the participants are.
Trial Locations
- Locations (1)
University Children's Hospital Zurich
🇨🇭Zürich, Switzerland