Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents

Type 1 Diabetes Mellitus Clinical Trial

Official title:

The Effect Of Tele-Nursing Application On Metabolic Control, Self-Efficacy, Quality Of Life And Anxiety Level Of Adolescents With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05211479
• Other study ID #: 2020-14
• Status: Completed
• Phase: N/A
• Start date: December 20, 2021
• Est. completion date: August 31, 2022

Study information

• Verified date: October 2022
• Source: University of Yalova
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Studies have shown that tele-nursing practice is effective in children with Type 1 Diabetes Mellitus, but the number of studies conducted is very few. No study examining the concepts of metabolic control, self-efficacy, quality of life and anxiety together was found in the literature review. With this study, it is aimed that diabetes education given by tele-nursing has an effect on metabolic control, self-efficacy, quality of life and anxiety level of adolescents with type 1 diabetes, and that diabetic adolescents can easily obtain the information they need about nursing care when they cannot come to the clinic.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 67
• Est. completion date: August 31, 2022
• Est. primary completion date: March 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

Inclusion Criteria:

Inclusion Criteria:

• The child is between the ages of 12-18,
• After the information, the adolescent agrees to participate in the study, and the parent gives written consent,
• The child can understand and speak Turkish,
• Parent's ability to understand and speak Turkish,
• Having a smart phone and having access to the internet,
• Having been diagnosed with T1DM at least 1 year ago,
• Being on insulin therapy by the subcutaneous route,
• Coming to the outpatient clinic at least once every 3 months. Exclusion Criteria:

Exclusion Criteria:

• Age younger than 12 or older than 18,
• Having another chronic disease,
• Using an insulin pump
• Having vision and hearing problems,
• Using the Continuous Glucose Tracking System,
• Having a physical or mental disability.

Related Conditions & MeSH terms

• Adolescent
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Telenursing
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• educational intervention
In the light of up-to-date information, "Type I Diabetes Education Guide" was created. With this guide, both face-to-face and tele-nursing training will be provided. Both working groups will receive training before starting research. The intervention group will continue their weekly training throughout the study.

Locations

Country	Name	City	State
Turkey	Yalova University	Yalova

Sponsors (1)

Lead Sponsor	Collaborator
University of Yalova

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Metabolic control level of adolescents with type 1 diabetes	HbA1c values were recorded before starting the study to determine the level of metabolic control. The HbA1c values will be followed up in the 3rd and 6th months of the research. When the adolescents go to the hospital for a routine control every 3 months, the HbA1c value will be checked from the blood values and the researcher will obtain it from the records.	Baseline, 12 weeks and 24 weeks after randomization
Primary	Evaluation of the level of self-efficacy of adolescents with type 1 diabetes	"Diabetes Self-Efficacy Scale in Adolescents with Type 1 Diabetes" was used to measure self-efficacy in diabetes management in adolescents aged 12-18 years with Type 1 Diabetes. Scale; medical treatment and nutrition, nutrition and insulin dose adjustment, being able to tell about diabetes, being honest with oneself and others (Ozturk, Ayar & Bektas, 2016). Participants will be asked to fill in the "Diabetes Self-Efficacy Scale in Adolescents with Type 1 Diabetes" scale to determine their self-efficacy levels in the 3rd and 6th months of the research.	Baseline, 12 weeks and 24 weeks after randomization
Primary	Evaluation of the level of quality of life of adolescents with type 1 diabetes	"Quality of Life Scale for Children Adolescent Form (Kiddo-KINDL)" was used to determine the level of quality of life of adolescents. The scale form consists of 30 items and dimensions of physical well-being, mental well-being, self-esteem, family, friends, school, and illness (Eser et al., 2004). In the 3rd and 6th months of the study, participants will be asked to fill in the "Quality of Life Scale for Children Adolescent Form" scale to determine their quality of life.	Baseline, 12 weeks and 24 weeks after randomization
Primary	Evaluation of the anxiety level of adolescents with type 1 diabetes	The scale is a self-report scale used in the evaluation of childhood anxiety disorders. The scale consists of 41 items and sub-dimensions of Panic Disorder/Somatic Disorder, Generalized Anxiety Disorder, Separation Anxiety, Social Anxiety, and School Fear. A cut-off value of 25 and above is accepted as a warning for anxiety disorder. An increase in the total score obtained from the scale means that the level of anxiety also increases (Cakmakci, 2004). Participants will be asked to fill in the "Childhood Anxiety Screening Scale" scale to determine their anxiety levels in the 3rd and 6th months of the study.	Baseline, 12 weeks and 24 weeks after randomization