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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06208618
• Other study ID #: YesimKorkusuz
• Status: Enrolling by invitation
• Phase: N/A
• Start date: January 15, 2024
• Est. completion date: June 15, 2024

Study information

• Verified date: February 2024
• Source: Eskisehir Osmangazi University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 96
• Est. completion date: June 15, 2024
• Est. primary completion date: June 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 13 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Motivational Interviewing
• Type 1 Diabetes

Intervention

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 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

Locations

Country	Name	City	State
Turkey	Eskisehir Osmangazi University	Eskisehir	Odunpazari

Sponsors (1)

Lead Sponsor	Collaborator
Eskisehir Osmangazi University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c level	HbA1c level	At the beginning of the study, at the 3rd month, and at the 6th month
Primary	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	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