Type 1 DiabetesNCT06208618
The Impact of Motivational Interviews Conducted Through Tele-Nursing on Diabetes Management
A study testing Education and Motivational Interviews in people with Type 1 Diabetes and Motivational Interviewing, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The deterioration of glycemic control in adolescents with Type 1 diabetes (T1DM) is a genuine cause for concern. Possible reasons for worsening glycemic control in youth include lack of monitoring, inadequate self-care, psychosocial factors, lack of family support and parental supervision, non-adherence to treatment… Read more about this study
- Who is it for?
- Ages 13 to 18 years
- Conditions the study is for
- Type 1 Diabetes, Motivational Interviewing
- What is being tested?
- Education and Motivational Interviews
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jun 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 13 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Diagnosed with Type 1 diabetes at least 6 months ago
- Under follow-up at Kütahya Evliya Çelebi Health Sciences University Training and Research Hospital Diabetes Education Unit
- Having an HbA1c level above 7.5% in the most recent measurement
- Having a smartphone
Who cannot join
- Refusal of legal guardian or the adolescent themselves to participate in the research
- Difficulty in communication or answering questions
- Having hearing, speech, vision, or cognitive impairments
- Being in the honeymoon period of Type 1 diabetes
- Having a second autoimmune disease, such as celiac disease, besides Type 1 diabetes
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Eskisehir Osmangazi University
Eskişehir, Odunpazarı, 26040
About this study
Official title: The Effect of Education and Motivational Interviews Conducted Through Tele-Nursing on Diabetes Management in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
The deterioration of glycemic control in adolescents with Type 1 diabetes (T1DM) is a genuine cause for concern. Possible reasons for worsening glycemic control in youth include lack of monitoring, inadequate self-care, psychosocial factors, lack of family support and parental supervision, non-adherence to treatment, pubertal increases in insulin resistance, and insufficient transition from pediatric to adult care. In adolescents with established T1DM who transition to adult-focused care, there is observed disengagement or complete detachment from care. Improving glycemic control during adolescence is a critical stage to enhance and reduce complications associated with T1DM. Adolescents with T1DM require appropriate daily insulin therapy, regular blood sugar monitoring, physical activity, healthy nutrition, education, and support to delay or prevent diabetes-related complications.This study aims to determine the impact of education and motivational interviews conducted through tele-nursing on the management of diabetes in adolescents with Type 1 diabetes.
Read the detailed description
The study will be conducted with a single-center, single-blind, parallel-group, randomized controlled design with a follow-up period of 6 months.The population of the study consists of 141 adolescents aged 13-18 diagnosed with Type 1 diabetes, who are being followed up at the Diabetes Education Unit of Evliya Çelebi Training and Research Hospital, affiliated with Kütahya Health Sciences University in the province of Kütahya, Türkiye. The sample of the study will consist of 96 adolescents, with 48 participants in each group, assuming a 1:1 randomization, based on the reference study. In their research, where motivational interviews were used for adolescents' diabetes management, the reported HbA1c levels for the study group (9.61±2.40) and the control group with routine follow-up (10.76±2.07) at the 6-month follow-up were considered, aiming for an 80% power and a 0.05 margin of error.
- Conditions
- Type 1 Diabetes, Motivational Interviewing
- Being tested
- Education and Motivational Interviews
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Education and Motivational InterviewsOther
The diabetes education aimed at supporting diabetes self-management in adolescents will include the following topics:
- What is Diabetes?
- Treatment in Diabetes
- Insulin Therapy
- Nutritional Therapy
- Physical Activity/Exercise
- Acute Complications of Diabetes
- Hypoglycemia
- Hyperglycemia
- Diabetic Ketoacidosis
- Diabetes Management in Illness
Motivational interviews will consist of the following stages:
- First Meeting - Pre-awareness (Pre-contemplation)
- Second Meeting - Awareness (Contemplation)
- Third Meeting - Preparation
- Fourth Meeting - Taking Action (Action)
- Fifth Meeting - Maintenance
- Sixth Meeting - Termination or Review
| Study group | Role | What they receive |
|---|---|---|
| Motivational interviews | Experimental | At the beginning of the study, individual face-to-face diabetes education will be provided for each adolescent in the study group on days corresponding to their routine medical appointments in the diabetes education room. The diabetes education will include the following topics:
* What is Diabetes?
* Treatment in Diabetes
* Insulin Therapy
* Nutritional Therapy
* Physical Activity/Exercise
* Acute Complications of Diabetes
* Hypoglycemia
* Hyperglycemia
* Diabetic Ketoacidosis
* Diabetes Management in IIlness
The adolescents in the study group will undergo a total of 6 motivational interviews, conducted once a month. Three of these interviews will be face-to-face (at the beginning of the study, at the 3rd month, and at the 6th month), while the remaining three will be conducted remotely using the WhatsApp video call feature (in the 2nd, 4th, and 5th months). Receives: Other: Education and Motivational Interviews |
| Routine follow-up | No intervention | The routine follow-up conducted by the diabetes education unit will continue for the study group, and no interventions will be made as part of the research. The study group will undergo a pre-test at the beginning of the study, a follow-up test at the 3rd month, and a post-test at the 6th month as part of the research. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c level
HbA1c level
Measured: At the beginning of the study, at the 3rd month, and at the 6th month
Diabetes management self-efficacy
It will be measured using the "Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes". The scale consists of a total of 26 items under four sub-dimensions named "medical treatment and nutrition", "glycemic assessment", "talking about your diabetes" and "honesty towards yourself and others".The items in the scale are answered according to the 5-point Likert system as "Definitely yes (1) - Definitely no (5)". Self-efficacy scores are summed and divided by the total number of items to indicate the strength of perceived self-efficacy for different levels of performance on the total of diabetes self-management activities. High scores on the scale represent low self-efficacy. The Cronbach Alpha reliability coefficient of the overall scale is 0.85; for the sub-dimensions are 0.80, 0.75, 0.70 and 0.70, respectively.
Measured: At the beginning of the study, at the 3rd month, and at the 6th month
Secondary outcomes (1)
Belief in a healthy lifestyle
It will be measured using the Healthy Lifestyle Belief Scale for Adolescents. The scale consists of a total of 16 items under three sub-dimensions named "health belief", "physical activity" and "nutrition". The items in the scale are answered according to the 5-point Likert system as "Strongly disagree (1) - Strongly agree (5)". A minimum of 16 and a maximum of 80 points can be obtained from the scale, and increasing scores from the scale indicates that adolescents' belief in a healthy life has increased. The Cronbach Alpha reliability coefficient of the overall scale is 0.90; for the sub-dimensions are 0.84, 0.79 and 0.81, respectively.
Measured: At the beginning of the study, at the 3rd month, and at the 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 Jan 2024
- Primary completion15 Jun 2024 (estimated)
- Study completion15 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- A single-center, single-blind, parallel-group, randomized controlled design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Duru, Eskisehir Osmangazi University
- Investigators
- Pınar Duru, Ph.D., Principal investigator, Eskisehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208618
- Sponsor's protocol ID
- YesimKorkusuz
- Status last verified
- Feb 2024
- First submitted
- 6 Jan 2024
- Last updated
- 13 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- 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 13 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Education and Motivational Interviews Conducted Through Tele-Nursing on Diabetes Management in Adolescents With Type 1 Diabetes: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06208618
- Acronym / sponsor ID
- YesimKorkusuz
- Conditions
- Type 1 Diabetes, Motivational Interviewing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jun 2024 (estimated)
- Study completion
- 15 Jun 2024 (estimated)
- First posted
- 17 Jan 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.
The deterioration of glycemic control in adolescents with Type 1 diabetes (T1DM) is a genuine cause for concern. Possible reasons for worsening glycemic control in youth include lack of monitoring, inadequate self-care, psychosocial factors, lack of family support and parental supervision, non-adherence to treatment, pubertal increases in insulin resistance, and insufficient transition from pediatric to adult care. In adolescents with established T1DM who transition to adult-focused care, there is observed disengagement or complete detachment from care. Improving glycemic control during adolescence is a critical stage to enhance and reduce complications associated with T1DM. Adolescents with T1DM require appropriate daily insulin therapy, regular blood sugar monitoring, physical activity, healthy nutrition, education, and support to delay or prevent diabetes-related complications.This study aims to determine the impact of education and motivational interviews conducted through tele-nursing on the management of diabetes in adolescents with Type 1 diabetes.
Detailed description
The study will be conducted with a single-center, single-blind, parallel-group, randomized controlled design with a follow-up period of 6 months.The population of the study consists of 141 adolescents aged 13-18 diagnosed with Type 1 diabetes, who are being followed up at the Diabetes Education Unit of Evliya Çelebi Training and Research Hospital, affiliated with Kütahya Health Sciences University in the province of Kütahya, Türkiye. The sample of the study will consist of 96 adolescents, with 48 participants in each group, assuming a 1:1 randomization, based on the reference study. In their research, where motivational interviews were used for adolescents' diabetes management, the reported HbA1c levels for the study group (9.61±2.40) and the control group with routine follow-up (10.76±2.07) at the 6-month follow-up were considered, aiming for an 80% power and a 0.05 margin of error.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A single-center, single-blind, parallel-group, randomized controlled design
| Arm | Type | Receives |
|---|---|---|
| Motivational interviews | Experimental | Other: Education and Motivational InterviewsAt the beginning of the study, individual face-to-face diabetes education will be provided for each adolescent in the study group on days corresponding to their routine medical appointments in the diabetes education room. The diabetes education will include the following topics: * What is Diabetes? * Treatment in Diabetes * Insulin Therapy * Nutritional Therapy * Physical Activity/Exercise * Acute Complications of Diabetes * Hypoglycemia * Hyperglycemia * Diabetic Ketoacidosis * Diabetes Management in IIlness The adolescents in the study group will undergo a total of 6 motivational interviews, conducted once a month. Three of these interviews will be face-to-face (at the beginning of the study, at the 3rd month, and at the 6th month), while the remaining three will be conducted remotely using the WhatsApp video call feature (in the 2nd, 4th, and 5th months). |
| Routine follow-up | No intervention | –The routine follow-up conducted by the diabetes education unit will continue for the study group, and no interventions will be made as part of the research. The study group will undergo a pre-test at the beginning of the study, a follow-up test at the 3rd month, and a post-test at the 6th month as part of the research. |
Who may qualify
- Ages
- 13 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Diagnosed with Type 1 diabetes at least 6 months ago
- Under follow-up at Kütahya Evliya Çelebi Health Sciences University Training and Research Hospital Diabetes Education Unit
- Having an HbA1c level above 7.5% in the most recent measurement
- Having a smartphone
Key exclusion criteria (5 listed)
- Refusal of legal guardian or the adolescent themselves to participate in the research
- Difficulty in communication or answering questions
- Having hearing, speech, vision, or cognitive impairments
- Being in the honeymoon period of Type 1 diabetes
- Having a second autoimmune disease, such as celiac disease, besides Type 1 diabetes
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 |
|---|---|---|
| Education and Motivational InterviewsThe diabetes education aimed at supporting diabetes self-management in adolescents will include the following topics: * What is Diabetes? * Treatment in Diabetes * Insulin Therapy * Nutritional Therapy * Physical Activity/Exercise * Acute Complications of Diabetes * Hypoglycemia * Hyperglycemia * Diabetic Ketoacidosis * Diabetes Management in Illness Motivational interviews will consist of the following stages: * First Meeting - Pre-awareness (Pre-contemplation) * Second Meeting - Awareness (Contemplation) * Third Meeting - Preparation * Fourth Meeting - Taking Action (Action) * Fifth Meeting - Maintenance * Sixth Meeting - Termination or Review | Other | Motivational interviews |
Primary outcome
HbA1c level
Time frame: At the beginning of the study, at the 3rd month, and at the 6th month
HbA1c level
Diabetes management self-efficacy
Time frame: At the beginning of the study, at the 3rd month, and at the 6th month
It will be measured using the "Diabetes Management Self-Efficacy Scale in Adolescents with Type 1 Diabetes". The scale consists of a total of 26 items under four sub-dimensions named "medical treatment and nutrition", "glycemic assessment", "talking about your diabetes" and "honesty towards yourself and others".The items in the scale are answered according to the 5-point Likert system as "Definitely yes (1) - Definitely no (5)". Self-efficacy scores are summed and divided by the total number of items to indicate the strength of perceived self-efficacy for different levels of performance on the total of diabetes self-management activities. High scores on the scale represent low self-efficacy. The Cronbach Alpha reliability coefficient of the overall scale is 0.85; for the sub-dimensions are 0.80, 0.75, 0.70 and 0.70, respectively.
1 secondary outcome
Belief in a healthy lifestyle
Time frame: At the beginning of the study, at the 3rd month, and at the 6th month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 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.
Pınar Duru, Ph.D. principal investigator
Eskisehir Osmangazi University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Education and Motivational Interviews in people with Type 1 Diabetes and Motivational Interviewing, run by Eskisehir Osmangazi 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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 13 Feb 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?
Results are not available in the source record.
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?
HbA1c level (time frame: At the beginning of the study, at the 3rd month, and at the 6th month). The study lists 2 primary outcomes in all. 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 13 Feb 2024.