The Association Between Diabetes Stress, Self-efficacy, Self-management, and Glycemic Control in Children and Adolescents With Type 1 Diabetes Mellitus

December 28, 2022 updated by: National Taiwan University Hospital
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).

Study Overview

Status

Not yet recruiting

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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

8 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demographic characteristics
Time Frame: 5 minutes
Demographic characteristics include participants' age, gender, diabetes treatment plan, body high and body weight; caregiver's age, income, education background, occupation and health condition.
5 minutes
Self-efficacy
Time Frame: 5 minutes
The 10-item Chinese version of the self-efficacy scale was used to measure self-confidence in facing potential challenges in diabetes self-management in children and adolescents with Type 1 Diabetes; the higher the item mean score, the higher the patient's self-efficacy.
5 minutes
Diabetes specific-stress
Time Frame: 10 minutes
The 24-item Diabetes Stress Questionnaire-short form (DSQ-SF) demonstrated good internal consistency and convergent validity; it's also a quick, cost-effective and useful tool for measuring perceived stress in youth with type 1 diabetes mellitus; higher scores indicating higher levels of diabetes specific-stress.
10 minutes
Self-management
Time Frame: 10 minutes
The 23-item Short Form Chinese version of the Self-Management of Type 1 Diabetes for Adolescents Scale (C-SMOD-A-23) was used to assess patient collaboration with parents; patient diabetes care activities, problem-solving behaviors and communication, and healthy lifestyle goals; the higher the item mean score, the greater the patient's self-management ability.
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 21, 2022

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

December 19, 2022

First Submitted That Met QC Criteria

December 19, 2022

First Posted (Actual)

December 28, 2022

Study Record Updates

Last Update Posted (Actual)

January 3, 2023

Last Update Submitted That Met QC Criteria

December 28, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Children and Adolescents With Type 1 Diabetes Mellitus

3
Subscribe