TelenursingNCT05211479
Tele Nursing Application For Type 1 Diabetes Mellitus Adolescents
A study testing educational intervention in people with Telenursing and Adolescent, run by University of Yalova at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Telenursing, Adolescent, Type 1 Diabetes Mellitus
- What is being tested?
- educational intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Dec 2021to 31 Aug 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- educational intervention
- Keywords
- Telenursing, Type 1 Diabetes Mellitus, Metabolic Control, Self Efficacy, Quality of Life, Anxiety
- Medical subject headings
- Diabetes Mellitus, Type 1, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
educational interventionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | 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. Receives: Behavioral: educational intervention |
| Control Group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12 weeks and 24 weeks after randomization
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.
Measured: Baseline, 12 weeks and 24 weeks after randomization
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.
Measured: Baseline, 12 weeks and 24 weeks after randomization
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.
Measured: Baseline, 12 weeks and 24 weeks after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start20 Dec 2021
- Primary completion15 Mar 2022
- Study completion31 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelenursingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled and quasi-experimental research
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Yalova
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emel AVÇİN, University of Yalova
- Investigators
- Emel AVÇİN, Doctorate, Principal investigator, University of Yalova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211479
- Sponsor's protocol ID
- 2020-14
- Status last verified
- Jul 2026
- First submitted
- 25 Nov 2021
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Avcin E, Acikgoz A. The effect of tele-nursing application on metabolic control, self-efficacy, quality of life and anxiety level in adolescents with Type 1 diabetes: A randomized controlled trial. J Pediatr Nurs. 2026 Mar-Apr;87:433-442. doi: 10.1016/j.pedn.2026.01.042. Epub 2026 Feb 6.
PubMed 41653762
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05211479
- Acronym / sponsor ID
- 2020-14
- Conditions
- Telenursing, Adolescent, Type 1 Diabetes Mellitus
- Keywords
- Telenursing, Type 1 Diabetes Mellitus, Metabolic Control, Self Efficacy, Quality of Life, Anxiety
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- University of YalovaUniversity, hospital or other
- Study start
- 20 Dec 2021 (actual)
- Primary completion
- 15 Mar 2022 (actual)
- Study completion
- 31 Aug 2022 (actual)
- First posted
- 27 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled and quasi-experimental research
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: educational interventionTele-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. |
| Control Group | No intervention | –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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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,
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| educational interventionIn 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. | Behavioural | intervention group |
Primary outcome
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.
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.
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- Derived from this study: PubMed 41653762Avcin E, Acikgoz A. The effect of tele-nursing application on metabolic control, self-efficacy, quality of life and anxiety level in adolescents with Type 1 diabetes: A randomized controlled trial. J Pediatr Nurs. 2026 Mar-Apr;87:433-442. doi: 10.1016/j.pedn.2026.01.042. Epub 2026 Feb 6.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emel AVÇİN, Doctorate principal investigator
University of Yalova
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing educational intervention in people with Telenursing and Adolescent, run by University of Yalova at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Metabolic control level of adolescents with type 1 diabetes (time frame: Baseline, 12 weeks and 24 weeks after randomization). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05211479, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2026.