Clinical trial NCT05666791: The Association Between Diabetes Stress, Self-efficacy, Self-management, and Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
Official title: The Association Between Diabetes Stress, Self-efficacy, Self-management, and Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Children and Adolescents With Type 1 Diabetes Mellitus
Keywords: Children and adolescents with type 1 diabetes mellitus, Diabetes stress, Self-efficacy, Self-management, HbA1c
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 200
Sex: ALL
Minimum age (years): 8
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Children and adolescents with type 1 diabetes mellitus being treated at NTUH will be recruited. The inclusion criteria were having had a diagnosis of type 1 diabetes mellitus for more than 6 months, screened and referred by a pediatric endocrinology physician, being aged 8\~25 years old, and also being able to read or communicate verbally in mandarin Chinese.

Brief summary: The aims of this study were to: (1) Investigate the association between perceived diabetes-specific stress, self-efficacy, self-management and glycemic control in children and adolescents with type 1 diabetes mellitus (T1D). (2) Explore whether self-efficacy and self-management mediates the relationship between perceived diabetes stress and glycemic control in adolescents with type 1 diabetes (T1D). (3) Explore whether self-efficacy and self-management moderated the relationship between perceived diabetes stress and glycemic control in adolescents with type 1 diabetes (T1D).

Detailed description: Investigators have found that type 1 diabetes mellitus (T1D) is more commonly diagnosed in childhood compared with adulthood; optimizing HbA1c level is essential for reducing the risk and severity of complications; childhood glycemic control is also associated with further risk of physical and psychological health problems as an adult, nevertheless, adolescence is a stage of transition to adulthood, compared with other age groups, and adolescents with type 1 diabetes mellitus (T1D) have worse glycemic control.

Diabetes-specific stress has been previously defined as a negative experience involving physiological, emotional, and behavior changes in relation to a diabetes specific stressor, it is also associated with psychological well-being and mediates the relationship between diabetes-specific cognitive appraisals and glycemic control.

Cross-sectional studies also indicate that self-efficacy and self-management are positively correlated, importantly, in adolescents with type 1 diabetes mellitus (T1D), higher self-efficacy was associated with lower HbA1c levels; higher self-efficacy was also directly associated with better self-management and lower HbA1c levels.

Individuals with type 1 diabetes mellitus (T1D) need to self-manage their HbA1c levels throughout their lives, self-management also refers to the daily active management of illness-related activities for achieving glycemic control; accordingly, self-management in adolescents is always challenging, and glycemic control is typically at its worst in the transitional period between adolescence and adulthood.

Considering that diabetes-specific stress might be directly associated with self-efficacy, self-management and glycemic control in children and adolescents with type 1 diabetes mellitus (T1D), further study is still warranted. Understanding the factors and pathways associated with subsequent HbA1c levels could assist in the development of comprehensive and timely interventions to improve glycemic control among this population.

This study applied as a cross-sectional study; Demographic characteristics, Diabetes-specific stress, self -efficacy and self-management were collected using self -reported questionnaires; HbA1c levels will be obtained from medical records.

Eligibility criteria: Inclusion Criteria:

* The inclusion criteria were having had a diagnosis of type 1 diabetes mellitus for more than 6 months, screened and referred by a pediatric endocrinology physician, being aged 8\~25 years old, and also being able to read or communicate verbally in mandarin Chinese.

Exclusion Criteria:

* Participants diagnosed with cognitive or mental health problems were excluded.

Primary outcomes:
measure: Demographic characteristics
timeFrame: 5 minutes
measure: Diabetes specific-stress
timeFrame: 10 minutes
measure: Self-management
timeFrame: 10 minutes
measure: Self-efficacy
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
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