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Completed

NCT Number: NCT05211479

Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents

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.

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Key information

Conditions

Telenursing Adolescent Anxiety Disorders Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Mental Disorders Metabolic Diseases Nutritional and Metabolic Diseases Type 1 Diabetes Mellitus

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yalova University

Yalova, 77200, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Educational intervention

Behavioral

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.

Primary outcomes

  1. Evaluation of Metabolic control level of adolescents with type 1 diabetes

    Time frame: Baseline, 12 weeks and 24 weeks after randomization

    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.

  2. Evaluation of the level of self-efficacy of adolescents with type 1 diabetes

    Time frame: Baseline, 12 weeks and 24 weeks after randomization

    "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.

  3. Evaluation of the level of quality of life of adolescents with type 1 diabetes

    Time frame: Baseline, 12 weeks and 24 weeks after randomization

    "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.

  4. Evaluation of the anxiety level of adolescents with type 1 diabetes

    Time frame: Baseline, 12 weeks and 24 weeks after randomization

    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 (Cakmakcı, 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.

Sponsors and collaborators

Lead sponsor

University of Yalova

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 27, 2022
Registry last updated
Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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