Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents

NCT ID: NCT05211479

Last Updated: 2022-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-20
• Study Completion Date: 2022-08-31

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.

Conditions

Telenursing; Adolescent; Type 1 Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

intervention group

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.

Group Type: EXPERIMENTAL

educational intervention

Intervention Type: 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.

Control Group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility 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

• 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.

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Yalova

OTHER

Sponsor Role: lead

Responsible Party

Emel AVÇİN

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Emel AVÇİN, Doctorate

Role: PRINCIPAL_INVESTIGATOR

University of Yalova

Locations

Yalova University

Yalova, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

2020-14

Identifier Type: -

Identifier Source: org_study_id