Diabetes Mellitus Self Management EducationNCT06717256
Evaluation of the Effect of Nurse Coaching Program on Self-management and Skin Care Behaviors in Patients With Diabetes
A study testing training in people with Diabetes Mellitus Self Management Education and Diabetes Mellitus, Type II, run by Necmettin Erbakan University.
Trial summary
This research will be conducted in a pre-test-post-test randomized controlled, single-blind experimental design to evaluate the effects of a nurse coaching program on self-management and skin care behaviors in patients with diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus Self Management Education, Diabetes Mellitus, Type II, Skin Care
- What is being tested?
- training
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- No sites listed yet
- Study dates
- 20 Dec 2024to 20 Jun 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65,
- Having a Type 2 DM diagnosis period of 6 months or more,
- Not having any psychiatric disorders or mental problems,
- Having hemoglobin A1c values <8 mmol/mL,
- Individuals who can perform diabetes self-management behaviors and skin care behaviors (regular eating habits, physical activity, regular monitoring of blood sugar, compliance with treatment, ability to solve problems, coping strategies and minimizing risks).
Who cannot join
- Having verbal communication problems,
- Having been diagnosed with Type 1 Diabetes Mellitus,
- Having been diagnosed with gestational diabetes mellitus,
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluation of the Effect of Nurse Coaching Program on Self-management and Skin Care Behaviors in Patients With Diabetes: a Randomized Controlled Trial.
This research will be conducted in a pre-test-post-test randomized controlled, single-blind experimental design to evaluate the effects of a nurse coaching program on self-management and skin care behaviors in patients with diabetes. The key question(s) it aims to answer are:
- Does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?
- Does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?
Read the detailed description
The study will be conducted in the internal medicine units of Mut State Hospital in the Mut district of Mersin between January 2025 and June 2025. An average of 100 patients with type 2 DM apply to the hospital per day. According to Cohen's effect size coefficients; it was decided to include 21 people (N=42) in the groups, assuming that the evaluations to be made between two independent groups would have a large effect size (d=0.8; large) according to the calculations made. The consents of 42 type 2 DM patients who constitute the study group of the experimental research will be obtained. After the preliminary tests are performed, a series of random numbers will be generated by an independent statistician and 21 will be assigned to the intervention group and 21 to the control group using the simple randomization method.
Personal Information Form, Diabetes Self-Management Scale, and Skin Care Behavior Monitoring Form will be used as Data Collection Tools. In addition, the "Diabetes Education Booklet" designed and prepared by the researchers will be used as an intervention material in the research study.The follow-up of the implementation process will be recorded with the MSF and KBIF prepared by the researcher.Before starting the research, 3 measurements will be taken at week 6 and week 12. The data collection process of the research will be completed by using face-to-face training opportunities in the first 6 weeks and reminders (message, phone call, etc.) in the following periods. The control group will receive standard training and the same measurement tools will be used.
- Being tested
- training
- Keywords
- Diabetes Mellitus Self Management Education, Skin Care, Tip II Diyabet Mellitus
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trainingBehavioural
Also called scin care, self-management
The diabetes education booklet is a collection of information designed by the researcher. These interventions will continue for 1.5 months, with a total of 6 sessions for each type 2 DM individual, lasting approximately 120 minutes (2 hours per week and 12 hours in total after 6 weeks), and will be carried out as reminders afterwards. In these sessions, agendas will be created appropriately on regular eating habits, physical activity, regular monitoring of blood sugar, compliance with treatment, problem-solving ability, coping strategies and minimizing risks, conflicts regarding self-management and skin care behaviors of the patient will be tried to be resolved, the patient's suitability and adaptation to the change phase will be determined, their willingness to change will be questioned, and the change plan will be helped in the matters of care and self-management.
| Study group | Role | What they receive |
|---|---|---|
| EDUCATION GROUP | Experimental | In addition to routine training provided by physicians to patients in this group, training will be provided within the first 6 weeks, where "the effect of the nurse coaching program on self-management and skin care behaviors in diabetic patients will be evaluated" and monthly reminders will be provided thereafter. The content of the training booklet prepared for self-management and skin care will be presented to the participants as a face-to-face training in the form of one-week presentations to be completed in 6 weeks, in the form of oral presentations. At the end of the module training, participants will be asked questions and answered. Six weeks after the training is completed, participants will be provided with reminders, and the trainings they want to be repeated will be repeated. Receives: Behavioral: training |
| CONTROL GROUP | No intervention | Participants assigned to the control group will receive information training as part of their check-ups, as in routine practice; however, the intervention program evaluating the effect of the nurse coaching program on self-management and skin care behaviors in diabetic patients will not be implemented. |
What is being measured
The primary outcome is the main question the study is designed to answer.
PERSONAL INFORMATION FORM
A two-part personal information form prepared by the researcher based on the literature (Herath et al. 2017; Kassahun et al. 2017; Ahmed et al. 2019; ADA 2021; Alaofè et al. 2021) was used. The Personal Information Form consists of 7 questions about socio-demographic characteristics (age, gender, marital status, educational status, presence of health insurance, economic status, place of residence) and 7 questions about disease-health characteristics (blood sugar measurement status, ability to take medications regularly, presence of any chronic disease other than diabetes, status of consulting a doctor for diabetes control, exercise status, status of receiving sufficient education regarding diabetes, if the answer is yes, what trainings have been received, measured HbA1C result).
Measured: Before the study.
Secondary outcomes (1)
Diabetes Self Management Questionnaire
This scale is a 16-item individual assessment scale developed by Schmitt et al. in 2013 to examine the relationship between diabetes self-management and glycemic control in diabetic patients. Participants are asked to answer the questions by considering their condition in the last 8 weeks. In the validity and reliability study conducted with 261 diabetic patients, Cronbach's alpha value was found to be 0.84. In the validity and reliability study conducted by Eroğlu and Sabuncu (2018), Cronbach's alpha value was found to be 0.85. The scale consists of 4 sub-dimensions. --Glucose Management: 1, 4, 6, 10, 12 (items 4 and 12 are related to medication use, items 1, 6 and 10 are related to blood sugar monitoring)
- Diet Control: 2, 5, 9, 13
- Physical Activity: 8, 11, 15
- Health Services Use: 3, 7, 14 Item 16 is not included in any sub-dimension. The scale is a 4-point Likert type.
Measured: Before application, at week 6 of application and at week 12 of application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2024
- Study start20 Dec 2024 (estimated)
- Primary completion20 Jan 2025 (estimated)
- Study completion20 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Self Management EducationStudies of the same condition, open and under way.
- More trials run by Necmettin Erbakan 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized controlled trial
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Necmettin Erbakan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burcu Kuccuk, Necmettin Erbakan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06717256
- Sponsor's protocol ID
- NecmettinEU-SBF-BK-01
- Status last verified
- Dec 2024
- First submitted
- 1 Dec 2024
- Last updated
- 9 Dec 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 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Nurse Coaching Program on Self-management and Skin Care Behaviors in Patients With Diabetes: a Randomized Controlled Trial.
- ClinicalTrials.gov ID
- NCT06717256
- Acronym / sponsor ID
- NecmettinEU-SBF-BK-01
- Keywords
- Diabetes Mellitus Self Management Education, Skin Care, Tip II Diyabet Mellitus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Necmettin Erbakan UniversityUniversity, hospital or other
- Study start
- 20 Dec 2024 (estimated)
- Primary completion
- 20 Jan 2025 (estimated)
- Study completion
- 20 Jun 2025 (estimated)
- First posted
- 4 Dec 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.
This research will be conducted in a pre-test-post-test randomized controlled, single-blind experimental design to evaluate the effects of a nurse coaching program on self-management and skin care behaviors in patients with diabetes. The key question(s) it aims to answer are:
- Does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?
- Does the nurse coaching program have no effect on self-management behaviors and skin care behaviors in patients with diabetes?
Detailed description
The study will be conducted in the internal medicine units of Mut State Hospital in the Mut district of Mersin between January 2025 and June 2025. An average of 100 patients with type 2 DM apply to the hospital per day. According to Cohen's effect size coefficients; it was decided to include 21 people (N=42) in the groups, assuming that the evaluations to be made between two independent groups would have a large effect size (d=0.8; large) according to the calculations made. The consents of 42 type 2 DM patients who constitute the study group of the experimental research will be obtained. After the preliminary tests are performed, a series of random numbers will be generated by an independent statistician and 21 will be assigned to the intervention group and 21 to the control group using the simple randomization method.
Personal Information Form, Diabetes Self-Management Scale, and Skin Care Behavior Monitoring Form will be used as Data Collection Tools. In addition, the "Diabetes Education Booklet" designed and prepared by the researchers will be used as an intervention material in the research study.The follow-up of the implementation process will be recorded with the MSF and KBIF prepared by the researcher.Before starting the research, 3 measurements will be taken at week 6 and week 12. The data collection process of the research will be completed by using face-to-face training opportunities in the first 6 weeks and reminders (message, phone call, etc.) in the following periods. The control group will receive standard training and the same measurement tools will be used.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| EDUCATION GROUP | Experimental | Behavioral: trainingIn addition to routine training provided by physicians to patients in this group, training will be provided within the first 6 weeks, where "the effect of the nurse coaching program on self-management and skin care behaviors in diabetic patients will be evaluated" and monthly reminders will be provided thereafter. The content of the training booklet prepared for self-management and skin care will be presented to the participants as a face-to-face training in the form of one-week presentations to be completed in 6 weeks, in the form of oral presentations. At the end of the module training, participants will be asked questions and answered. Six weeks after the training is completed, participants will be provided with reminders, and the trainings they want to be repeated will be repeated. |
| CONTROL GROUP | No intervention | –Participants assigned to the control group will receive information training as part of their check-ups, as in routine practice; however, the intervention program evaluating the effect of the nurse coaching program on self-management and skin care behaviors in diabetic patients will not be implemented. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Being between the ages of 18-65,
- Having a Type 2 DM diagnosis period of 6 months or more,
- Not having any psychiatric disorders or mental problems,
- Having hemoglobin A1c values <8 mmol/mL,
- Individuals who can perform diabetes self-management behaviors and skin care behaviors (regular eating habits, physical activity, regular monitoring of blood sugar, compliance with treatment, ability to solve problems, coping strategies and minimizing risks).
Key exclusion criteria (3 listed)
- Having verbal communication problems,
- Having been diagnosed with Type 1 Diabetes Mellitus,
- Having been diagnosed with gestational diabetes mellitus,
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 |
|---|---|---|
| trainingAlso: scin care, self-managementThe diabetes education booklet is a collection of information designed by the researcher. These interventions will continue for 1.5 months, with a total of 6 sessions for each type 2 DM individual, lasting approximately 120 minutes (2 hours per week and 12 hours in total after 6 weeks), and will be carried out as reminders afterwards. In these sessions, agendas will be created appropriately on regular eating habits, physical activity, regular monitoring of blood sugar, compliance with treatment, problem-solving ability, coping strategies and minimizing risks, conflicts regarding self-management and skin care behaviors of the patient will be tried to be resolved, the patient's suitability and adaptation to the change phase will be determined, their willingness to change will be questioned, and the change plan will be helped in the matters of care and self-management. | Behavioural | EDUCATION GROUP |
Primary outcome
PERSONAL INFORMATION FORM
Time frame: Before the study.
A two-part personal information form prepared by the researcher based on the literature (Herath et al. 2017; Kassahun et al. 2017; Ahmed et al. 2019; ADA 2021; Alaofè et al. 2021) was used. The Personal Information Form consists of 7 questions about socio-demographic characteristics (age, gender, marital status, educational status, presence of health insurance, economic status, place of residence) and 7 questions about disease-health characteristics (blood sugar measurement status, ability to take medications regularly, presence of any chronic disease other than diabetes, status of consulting a doctor for diabetes control, exercise status, status of receiving sufficient education regarding diabetes, if the answer is yes, what trainings have been received, measured HbA1C result).
1 secondary outcome
Diabetes Self Management Questionnaire
Time frame: Before application, at week 6 of application and at week 12 of application
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 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.
Questions about this trial
What is this clinical trial studying?
A study testing training in people with Diabetes Mellitus Self Management Education and Diabetes Mellitus, Type II, run by Necmettin Erbakan University.
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 5 inclusion and 3 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: opening soon, as of the sponsor's last update on 9 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact BURCU KÜÇÇÜK, MSC (+905449140630, mut.buglem.mersin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PERSONAL INFORMATION FORM (time frame: Before the study.). 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 9 Dec 2024.