type1diabetesNCT06246279
Disease Management in Adolescents With Type 1 Diabetes
A study testing Adaptation to Adolescence and Type 1 Diabetes Management Training Program in people with type1diabetes and Adolescent Behavior, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial summary
Adolescence period; It is a transition period of rapid growth, development and maturation in biochemical, physical, social and spiritual terms, which lasts from the beginning of puberty to young adulthood. Adolescence is a predictable developmental transition period for the individual. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- type1diabetes, Adolescent Behavior, Self Efficacy
- What is being tested?
- Adaptation to Adolescence and Type 1 Diabetes Management Training Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2022to 30 Apr 2024
- 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
- Having been diagnosed with type 1 diabetes in the last 6 months
- HbA1c level >7.5
Who cannot join
- presence of a diagnosis of intellectual disability, autism spectrum disorder and psychotic disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of the Education Program Prepared in Line With Transition Theory on Adaptation to Adolescence and Disease Management in Adolescents With Type 1 Diabetes: Randomized Controlled Study
Adolescence period; It is a transition period of rapid growth, development and maturation in biochemical, physical, social and spiritual terms, which lasts from the beginning of puberty to young adulthood. Adolescence is a predictable developmental transition period for the individual. They also encounter unpredictable situations (such as childhood illnesses). One of these conditions is Type 1 Diabetes Mellitus, which is the most common metabolic endocrine system disease in adolescents. Type 1 diabetes is an important health/disease transition in the life of a child and adolescent. Therefore, this study aimed to determine the effect of the "Adaptation to Adolescence and Type 1 Diabetes Management Training Programme", prepared in line with Meleis's Transition Theory, on the adolescent's developmental transition adaptation, self-efficacy for diabetes management and glycemic control.
- Conditions
- type1diabetes, Adolescent Behavior, Self Efficacy
- Being tested
- Adaptation to Adolescence and Type 1 Diabetes Management Training Program
- Keywords
- Type 1 Diabetes, Transition Theory, Diabetes Management, Pediatric Nurse, Randomized Controlled Trial
- Medical subject headings
- Adolescent Behavior, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adaptation to Adolescence and Type 1 Diabetes Management Training ProgramBehavioural
The content of the Training Program was created by researchers based on Transition Theory, in line with high-level research results and international guides. Then, the necessary arrangements were made by taking the opinions of 10 experts (child health and disease nursing faculty member, child and adolescent mental health specialist, child endocrinologist, child development specialist, nutrition and dietetics specialist, sports training specialist). The content was finalized in line with the comments received.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | In addition to the institution's routine T1DM training, the "Adjustment to Adolescence and Transition to Type 1 Diabetes Education Program" prepared in line with Meleis's Transition Theory was applied to adolescents online via the Microsoft Teams Program. Receives: Behavioral: Adaptation to Adolescence and Type 1 Diabetes Management Training Program |
| Control group | No intervention | The institution's routinely planned diabetes education was given by the pediatric diabetes education nurse. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reynolds Adjustment Screening Inventory for Adolescents
Reynolds Adjustment Screening Inventory has four subscales. These; emotional distress (10 items), antisocial behavior (8 items), positive self (6 items related to self-confidence and socialization) and anger control problems (8 items). The Cronbach alpha value of the scale is stated as 0.91. The lowest score of the scale is 32 and the highest score is 165.
Measured: This scale was administered three times at beginning, 3rd and 6th months.
Secondary outcomes (2)
Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
The scale is used to determine the educational needs of adolescents or to evaluate the effectiveness of diabetes education programs. The scale consists of 26 items ranging from 1 (completely agree) to 5 (strongly disagree). The lowest total score that can be obtained from the scale is 26 and the highest is 130. A higher score indicates less self-efficacy. The Cronbach's alpha coefficient of the scale was found to be 0.85.
Measured: This scale was administered three times at beginning, 3rd and 6th months.
Glycemic Control - Hemoglobin A1C
Glycemic control was assessed by HbA1C level. In Type 1 Diabetes, Hb A1C level is one of the basic control parameters checked in the clinic in adolescents. It is repeated routinely every 3 months when the child comes to the outpatient clinic for control for Type 1 Diabetes.
Measured: This scale was administered three times at beginning, 3rd and 6th months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start1 Apr 2022
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ceren Calik, Akdeniz University
- Investigators
- Ceren Calik, Principal investigator, Akdeniz Univercity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246279
- Sponsor's protocol ID
- AdolescentswithType1Diabete
- Status last verified
- Jul 2024
- First submitted
- 30 Jan 2024
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Education Program Prepared in Line With Transition Theory on Adaptation to Adolescence and Disease Management in Adolescents With Type 1 Diabetes: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06246279
- Acronym / sponsor ID
- AdolescentswithType1Diabete
- Conditions
- type1diabetes, Adolescent Behavior, Self Efficacy
- Keywords
- Type 1 Diabetes, Transition Theory, Diabetes Management, Pediatric Nurse, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 7 Feb 2024 (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.
Adolescence period; It is a transition period of rapid growth, development and maturation in biochemical, physical, social and spiritual terms, which lasts from the beginning of puberty to young adulthood. Adolescence is a predictable developmental transition period for the individual. They also encounter unpredictable situations (such as childhood illnesses). One of these conditions is Type 1 Diabetes Mellitus, which is the most common metabolic endocrine system disease in adolescents. Type 1 diabetes is an important health/disease transition in the life of a child and adolescent. Therefore, this study aimed to determine the effect of the "Adaptation to Adolescence and Type 1 Diabetes Management Training Programme", prepared in line with Meleis's Transition Theory, on the adolescent's developmental transition adaptation, self-efficacy for diabetes management and glycemic control.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Behavioral: Adaptation to Adolescence and Type 1 Diabetes Management Training ProgramIn addition to the institution's routine T1DM training, the "Adjustment to Adolescence and Transition to Type 1 Diabetes Education Program" prepared in line with Meleis's Transition Theory was applied to adolescents online via the Microsoft Teams Program. |
| Control group | No intervention | –The institution's routinely planned diabetes education was given by the pediatric diabetes education nurse. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Having been diagnosed with type 1 diabetes in the last 6 months
- HbA1c level >7.5
Key exclusion criteria (1 listed)
- presence of a diagnosis of intellectual disability, autism spectrum disorder and psychotic disorder
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 |
|---|---|---|
| Adaptation to Adolescence and Type 1 Diabetes Management Training ProgramThe content of the Training Program was created by researchers based on Transition Theory, in line with high-level research results and international guides. Then, the necessary arrangements were made by taking the opinions of 10 experts (child health and disease nursing faculty member, child and adolescent mental health specialist, child endocrinologist, child development specialist, nutrition and dietetics specialist, sports training specialist). The content was finalized in line with the comments received. | Behavioural | Experimental group |
Primary outcome
Reynolds Adjustment Screening Inventory for Adolescents
Time frame: This scale was administered three times at beginning, 3rd and 6th months.
Reynolds Adjustment Screening Inventory has four subscales. These; emotional distress (10 items), antisocial behavior (8 items), positive self (6 items related to self-confidence and socialization) and anger control problems (8 items). The Cronbach alpha value of the scale is stated as 0.91. The lowest score of the scale is 32 and the highest score is 165.
2 secondary outcomes
Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes
Time frame: This scale was administered three times at beginning, 3rd and 6th months.
Glycemic Control - Hemoglobin A1C
Time frame: This scale was administered three times at beginning, 3rd and 6th months.
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 31 Jul 2024.
- Individual participant dataSharing planned: No
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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.
Ceren Calik principal investigator
Akdeniz Univercity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adaptation to Adolescence and Type 1 Diabetes Management Training Program in people with type1diabetes and Adolescent Behavior, run by Akdeniz University 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 2 inclusion and 1 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 31 Jul 2024. 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?
Reynolds Adjustment Screening Inventory for Adolescents (time frame: This scale was administered three times at beginning, 3rd and 6th months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jul 2024.