The Impact of Motivational Interviews Conducted Through Tele-Nursing on Diabetes Management

NCT06208618 | Enrolling By Invitation

• 1 other identifier: YesimKorkusuz
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

The deterioration of glycemic control in adolescents with Type 1 diabetes (T1DM) is a genuine cause for concern. Possible reasons for worsening glycemic control in youth include lack of monitoring, inadequate self-care, psychosocial factors, lack of family support and parental supervision, non-adherence to treatment, pubertal increases in insulin resistance, and insufficient transition from pediatric to adult care. In adolescents with established T1DM who transition to adult-focused care, there is observed disengagement or complete detachment from care. Improving glycemic control during adolescence is a critical stage to enhance and reduce complications associated with T1DM. Adolescents with T1DM require appropriate daily insulin therapy, regular blood sugar monitoring, physical activity, healthy nutrition, education, and support to delay or prevent diabetes-related complications.This study aims to determine the impact of education and motivational interviews conducted through tele-nursing on the management of diabetes in adolescents with Type 1 diabetes.

Conditions

Type 1 Diabetes; Motivational Interviewing

Outcome Measures

Primary Outcomes (2)

• HbA1c level

  HbA1c level

  At the beginning of the study, at the 3rd month, and at the 6th month

• Diabetes management self-efficacy

  It will be measured using the "Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes". The scale consists of a total of 26 items under four sub-dimensions named "medical treatment and nutrition", "glycemic assessment", "talking about your diabetes" and "honesty towards yourself and others".The items in the scale are answered according to the 5-point Likert system as "Definitely yes (1) - Definitely no (5)". Self-efficacy scores are summed and divided by the total number of items to indicate the strength of perceived self-efficacy for different levels of performance on the total of diabetes self-management activities. High scores on the scale represent low self-efficacy. The Cronbach Alpha reliability coefficient of the overall scale is 0.85; for the sub-dimensions are 0.80, 0.75, 0.70 and 0.70, respectively.

  At the beginning of the study, at the 3rd month, and at the 6th month

Secondary Outcomes (1)

• Belief in a healthy lifestyle

  At the beginning of the study, at the 3rd month, and at the 6th month

Study Arms (2)

Motivational interviews

EXPERIMENTAL

At the beginning of the study, individual face-to-face diabetes education will be provided for each adolescent in the study group on days corresponding to their routine medical appointments in the diabetes education room. The diabetes education will include the following topics: * What is Diabetes? * Treatment in Diabetes * Insulin Therapy * Nutritional Therapy * Physical Activity/Exercise * Acute Complications of Diabetes * Hypoglycemia * Hyperglycemia * Diabetic Ketoacidosis * Diabetes Management in IIlness The adolescents in the study group will undergo a total of 6 motivational interviews, conducted once a month. Three of these interviews will be face-to-face (at the beginning of the study, at the 3rd month, and at the 6th month), while the remaining three will be conducted remotely using the WhatsApp video call feature (in the 2nd, 4th, and 5th months).

Other: Education and Motivational Interviews

Routine follow-up

NO INTERVENTION

The routine follow-up conducted by the diabetes education unit will continue for the study group, and no interventions will be made as part of the research. The study group will undergo a pre-test at the beginning of the study, a follow-up test at the 3rd month, and a post-test at the 6th month as part of the research.

Interventions

Education and Motivational Interviews OTHER

The diabetes education aimed at supporting diabetes self-management in adolescents will include the following topics: * What is Diabetes? * Treatment in Diabetes * Insulin Therapy * Nutritional Therapy * Physical Activity/Exercise * Acute Complications of Diabetes * Hypoglycemia * Hyperglycemia * Diabetic Ketoacidosis * Diabetes Management in Illness Motivational interviews will consist of the following stages: * First Meeting - Pre-awareness (Pre-contemplation) * Second Meeting - Awareness (Contemplation) * Third Meeting - Preparation * Fourth Meeting - Taking Action (Action) * Fifth Meeting - Maintenance * Sixth Meeting - Termination or Review

Motivational interviews

Eligibility Criteria

• Age: 13 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Diagnosed with Type 1 diabetes at least 6 months ago
• Under follow-up at Kütahya Evliya Çelebi Health Sciences University Training and Research Hospital Diabetes Education Unit
• Having an HbA1c level above 7.5% in the most recent measurement
• Having a smartphone

You may not qualify if:

• Refusal of legal guardian or the adolescent themselves to participate in the research
• Difficulty in communication or answering questions
• Having hearing, speech, vision, or cognitive impairments
• Being in the honeymoon period of Type 1 diabetes
• Having a second autoimmune disease, such as celiac disease, besides Type 1 diabetes

Sponsors & Collaborators

• Eskisehir Osmangazi University: lead

Study Sites (1)

Eskisehir Osmangazi University

Eskişehir, Odunpazarı, 26040, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Educational Status

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Socioeconomic Factors; Population Characteristics

Study Officials

• Pınar Duru, Ph.D.

  Eskisehir Osmangazi University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Single-blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: A single-center, single-blind, parallel-group, randomized controlled design

Study Record Dates

• First Submitted: January 6, 2024
• First Posted: January 17, 2024
• Study Start: January 15, 2024
• Primary Completion: June 15, 2024
• Study Completion: June 15, 2024
• Last Updated: February 13, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)