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

NCT ID: NCT06694467

Last Updated: 2024-11-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-01
• Study Completion Date: 2023-11-15

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.

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention group

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

Group Type: EXPERIMENTAL

Education program

Intervention Type: 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.

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education program

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Diabetes education program

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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Near East University, Turkey

OTHER

Sponsor Role: lead

Responsible Party

Salah Alzawahreh

RN, MSc

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Nursing

Nicosia, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: DERIVED

PMID: 39658013 (View on PubMed)

Other Identifiers

NEU/2023/110-1681

Identifier Type: -

Identifier Source: org_study_id