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Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents

Primary Purpose

Telenursing, Adolescent, Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
educational intervention
Sponsored by
University of Yalova
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Telenursing focused on measuring Telenursing, Type 1 Diabetes Mellitus, Metabolic Control, Self Efficacy, Quality of Life, Anxiety

Eligibility Criteria

12 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Yalova University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

intervention group

Control Group

Arm Description

Tele-nursing will be applied to adolescents in this group for 24 weeks. Weekly meeting and blood glucose monitoring will be done. The HbA1c value will be checked and the scales will be filled by meeting 3 times in total with 3 months intervals.

This group will be given face-to-face training only in the first encounter. During the research, no interviews will be provided through tele nursing. Only at the 3rd and 6th months will be interviewed to measure the HbA1c value and to fill the scales.

Outcomes

Primary Outcome Measures

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.
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.
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.
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 (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.

Secondary Outcome Measures

Full Information

First Posted
November 25, 2021
Last Updated
October 31, 2022
Sponsor
University of Yalova
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1. Study Identification

Unique Protocol Identification Number
NCT05211479
Brief Title
Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
December 20, 2021 (Actual)
Primary Completion Date
March 15, 2022 (Actual)
Study Completion Date
August 31, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Yalova

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Telenursing, Adolescent, Type 1 Diabetes Mellitus
Keywords
Telenursing, Type 1 Diabetes Mellitus, Metabolic Control, Self Efficacy, Quality of Life, Anxiety

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled and quasi-experimental research
Masking
None (Open Label)
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
intervention group
Arm Type
Experimental
Arm Description
Tele-nursing will be applied to adolescents in this group for 24 weeks. Weekly meeting and blood glucose monitoring will be done. The HbA1c value will be checked and the scales will be filled by meeting 3 times in total with 3 months intervals.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
This group will be given face-to-face training only in the first encounter. During the research, no interviews will be provided through tele nursing. Only at the 3rd and 6th months will be interviewed to measure the HbA1c value and to fill the scales.
Intervention Type
Behavioral
Intervention Name(s)
educational intervention
Intervention Description
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 Outcome Measure Information:
Title
Evaluation of Metabolic control level of adolescents with type 1 diabetes
Description
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.
Time Frame
Baseline, 12 weeks and 24 weeks after randomization
Title
Evaluation of the level of self-efficacy of adolescents with type 1 diabetes
Description
"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.
Time Frame
Baseline, 12 weeks and 24 weeks after randomization
Title
Evaluation of the level of quality of life of adolescents with type 1 diabetes
Description
"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.
Time Frame
Baseline, 12 weeks and 24 weeks after randomization
Title
Evaluation of the anxiety level of adolescents with type 1 diabetes
Description
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.
Time Frame
Baseline, 12 weeks and 24 weeks after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emel AVÇİN, Doctorate
Organizational Affiliation
University of Yalova
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yalova University
City
Yalova
ZIP/Postal Code
77200
Country
Turkey

12. IPD Sharing Statement

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Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents

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