Clinical trial NCT06208618: The Impact of Motivational Interviews Conducted Through Tele-Nursing on Diabetes Management
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Type 1 Diabetes
Motivational Interviewing
Lead sponsor: Eskisehir Osmangazi University
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 96
Sex: ALL
Minimum age (years): 13
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-center, single-blind, parallel-group, randomized controlled design
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: HbA1c level
timeFrame: At the beginning of the study, at the 3rd month, and at the 6th month
measure: Diabetes management self-efficacy
timeFrame: At the beginning of the study, at the 3rd month, and at the 6th month
Secondary outcomes:
measure: Belief in a healthy lifestyle
timeFrame: At the beginning of the study, at the 3rd month, and at the 6th month
Other outcomes:
Locations:
city: Eskişehir
country: Turkey
facility: Eskisehir Osmangazi University
state: Odunpazarı
Study officials:
affiliation: Eskisehir Osmangazi University
name: Pınar Duru, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: