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

The Effect of Education and Motivational Interviews Conducted Through Tele-Nursing on Diabetes Management in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Type 1 Diabetes; Motivational Interviewing
• Intervention / Treatment: Other: Education and Motivational Interviews

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.

• Study Type: Interventional
• Enrollment (Estimated): 96
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Odunpazarı
    • Eskişehir, Odunpazarı, Turkey, 26040
      • Eskisehir Osmangazi University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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 DiabetesHypoglycemiaHyperglycemiaDiabetic 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; 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 DiabetesHypoglycemiaHyperglycemiaDiabetic 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
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Belief in a healthy lifestyle	It will be measured using the Healthy Lifestyle Belief Scale for Adolescents. The scale consists of a total of 16 items under three sub-dimensions named "health belief", "physical activity" and "nutrition". The items in the scale are answered according to the 5-point Likert system as "Strongly disagree (1) - Strongly agree (5)". A minimum of 16 and a maximum of 80 points can be obtained from the scale, and increasing scores from the scale indicates that adolescents' belief in a healthy life has increased. The Cronbach Alpha reliability coefficient of the overall scale is 0.90; for the sub-dimensions are 0.84, 0.79 and 0.81, respectively.	At the beginning of the study, at the 3rd month, and at the 6th month

Collaborators and Investigators

• Sponsor: Eskisehir Osmangazi University
• Investigators: Principal Investigator: Pınar Duru, Ph.D., Eskisehir Osmangazi University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2024
• Primary Completion (Estimated): June 15, 2024
• Study Completion (Estimated): June 15, 2024

Study Registration Dates

• First Submitted: January 6, 2024
• First Submitted That Met QC Criteria: January 6, 2024
• First Posted (Actual): January 17, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2024
• Last Update Submitted That Met QC Criteria: February 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: YesimKorkusuz

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No