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

NCT ID: NCT06208618

Last Updated: 2024-02-13

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-01-15
• Study Completion Date: 2024-06-15

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.

Detailed Description

The study will be conducted with a single-center, single-blind, parallel-group, randomized controlled design with a follow-up period of 6 months.The population of the study consists of 141 adolescents aged 13-18 diagnosed with Type 1 diabetes, who are being followed up at the Diabetes Education Unit of Evliya Çelebi Training and Research Hospital, affiliated with Kütahya Health Sciences University in the province of Kütahya, Türkiye. The sample of the study will consist of 96 adolescents, with 48 participants in each group, assuming a 1:1 randomization, based on the reference study. In their research, where motivational interviews were used for adolescents' diabetes management, the reported HbA1c levels for the study group (9.61±2.40) and the control group with routine follow-up (10.76±2.07) at the 6-month follow-up were considered, aiming for an 80% power and a 0.05 margin of error.

Conditions

Type 1 Diabetes; Motivational Interviewing

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Motivational interviews

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).

Group Type: EXPERIMENTAL

Education and Motivational Interviews

Intervention Type: 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

Routine follow-up

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Education and Motivational Interviews

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: lead

Responsible Party

Pınar Duru

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Pınar Duru, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Eskisehir Osmangazi University

Locations

Eskisehir Osmangazi University

Eskişehir, Odunpazarı, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

YesimKorkusuz

Identifier Type: -

Identifier Source: org_study_id