Improving Self-Efficacy, Quality of Life and Glycemic Control in Adolescents With Type 1 Diabetes

NCT06694467 | Completed

• 1 other identifier: NEU/2023/110-1681
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Diabetes mellitus; Quality of life

Outcome Measures

Primary Outcomes (2)

• Glycosylated hemoglobin level

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

  6 months

• Quality of life

  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.

  6 months

Study Arms (2)

Intervention group

EXPERIMENTAL

An official diabetes education program and family empowerment model where employed, designed to provide people with diabetes and their families the information and abilities they need to manage their condition effectively. Types of diabetes, blood sugar control, self-monitoring methods, nutrition, meal planning, physical activity recommendations, medication management, and problem-solving approaches are all included in these programs

Behavioral: Education program

Control group

NO INTERVENTION

Patients diagnosed with type 1 diabetes mellitus for six months or more and had not attended any form of structured diabetes education including hospital-based classes or community group diabetes education classes for the preceding month of the study. These parameters were adopted to ensure that study takes place in a controlled environment and targets the aspects of intervention of study.

Interventions

Education program BEHAVIORAL

An official diabetes education program designed to provide people with diabetes and their families the information and abilities they need to manage their condition effectively. Diabetes kinds, blood sugar control, self-monitoring methods, nutrition, meal planning, physical activity recommendations, medication management, and problem-solving approaches are all included in these programs. Additionally, they offer psychological assistance to help people manage the emotional challenges of having diabetes.

Also known as: Diabetes education program

Intervention group

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Near East University, Turkey: lead

Study Sites (1)

Faculty of Nursing

Nicosia, Turkey (Türkiye)

Location

Related Publications (1)

• Alzawahreh S, Ozturk C. Improving Self-Efficacy, Quality of Life, and Glycemic Control in Adolescents With Type 1 Diabetes: Randomized Controlled Trial for the Evaluation of the Family-Centered Empowerment Model. JMIR Form Res. 2024 Dec 10;8:e64463. doi: 10.2196/64463.

  PMID: 39658013 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Interventions

Early Intervention, Educational

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Child Health Services; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Preventive Health Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: RN, MSc

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 19, 2024
• Study Start: April 1, 2023
• Primary Completion: July 30, 2023
• Study Completion: November 15, 2023
• Last Updated: November 19, 2024

Record last verified: 2024-11

Locations

TU (1)