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Clinical Trials/NCT06694467
NCT06694467
Completed
Not Applicable

Improving Self-Efficacy, Quality of Life and Glycemic Control in Adolescents With Type 1 Diabetes: An Experimental Evaluation of the Family Centered Empowerment Model

Near East University, Turkey1 site in 1 country68 target enrollmentApril 1, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 1 Diabetes Mellitus
Sponsor
Near East University, Turkey
Enrollment
68
Locations
1
Primary Endpoint
Glycosylated hemoglobin level
Status
Completed
Last Updated
last year

Overview

Brief Summary

Empowerment in healthcare, particularly in the context of chronic illness management such as diabetes, entails equipping patients with knowledge, expertise, and self-assurance to proactively oversee their health and make well-informed choices. This encompasses comprehensive strategies that target psychological, social, and lifestyle elements with the goal of enhancing self-confidence and health results. The objective of this research is to evaluate how the Family-Centered Empowerment Model affects the clinical and psychological outcomes of adolescents with Type 1 Diabetes, with an emphasis on increases in quality of life, self-efficacy, and glycosylated hemoglobin (HbA1c) levels.

Detailed Description

Diabetes mellitus (DM) is a prevalent and increasingly acknowledged medical disorder that affects individuals worldwide. It is a metabolic condition marked by elevated blood glucose levels that can cause serious side effects like renal failure, heart disease, blindness, and even amputations. To provide a better understanding of the Family-Centered Empowerment Model intervention applied in this work, the components and delivery modes are described in more detail below. Furthermore, a figure or a table suggested at this part could help to present this information more shortly. Details about the intervention The Family-Centered Empowerment Model intervention aimed to help engage the adolescent, an individual with type 1 DM, and his/her family in the self management process. The purpose of this study was to improve coping skills with type 1 DM population by increasing teamwork between adolescents and their members of their household.

Registry
clinicaltrials.gov
Start Date
April 1, 2023
End Date
November 15, 2023
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Near East University, Turkey
Responsible Party
Principal Investigator
Principal Investigator

Salah Alzawahreh

RN, MSc

Near East University, Turkey

Eligibility Criteria

Inclusion Criteria

  • Individuals with type 1 diabetes, ages 12 to 18 years
  • Patients who had not taken part in any professional diabetes education program within a month of receiving their diagnosis
  • Patients who had been diagnosed at least six months earlier to the commencement of the study.

Exclusion Criteria

  • Adolescents who had severe long-term diseases
  • Patients newly diagnosed type 1 diabetes.
  • those who were enrolled in a diabetes education program one month or less prior to the commencement of the study.

Outcomes

Primary Outcomes

Glycosylated hemoglobin level

Time Frame: 6 months

Serum glycosylated hemoglobin level was measured as a baseline, then 6 months after the intervention, to measure the mean difference between the two readings.

Quality of life

Time Frame: 6 months

Pediatric Quality of Life-Diabetes Module was used. The twenty-eight items in this multidimensional tool are categorized into five domains: treatment obstacles (four items), treatment adherence (seven items), concern (three items), and diabetic symptoms (eleven items). For teenage self-report, a five-point Likert scale was employed. The total number of questions divided by the total number of answers is how scale scores are calculated.

Study Sites (1)

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