Nurse's RoleNCT05870293
EFFECT OF DIABETES NURSE COACHING ON DIABETES
A study testing nurse coaching in people with Nurse's Role and Diabetes Mellitus, Type 2, run by Tuğba Bilgehan at 1 site in Turkey (Türkiye).
Trial summary
American Diabetes Association and American Clinical Endocrinology American Association of Clinical Endocrinologists, treatment and care of individuals with diabetes in achieving their goals; regulation of nutrition, regulation of physical activity, pharmacological treatment, diabetes education, continuous monitoring… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nurse's Role, Diabetes Mellitus, Type 2
- What is being tested?
- nurse coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2023to 1 Jul 2023
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Who voluntarily agrees to participate in the study,
- Having a smart phone and using it actively,
- Those between the ages of 18-65,
- The patient who was diagnosed with type 2 diabetes at least 1 year ago,
- The individual with type 2 diabetes has not developed any chronic complications,
- HbA1c > 6.5
- Absence of any psychiatric problems.
Who cannot join
- not attending the coaching interview
- unwillingness to quit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE EFFECT OF GOAL-SETTING DIABETES NURSE COACHING ON HbA1c VALUE AND STRENGTHENING DIABETES
American Diabetes Association and American Clinical Endocrinology American Association of Clinical Endocrinologists, treatment and care of individuals with diabetes in achieving their goals; regulation of nutrition, regulation of physical activity, pharmacological treatment, diabetes education, continuous monitoring and health checks should be done.
emphasizes (3,4). Individuals with diabetes receive diabetes self-management education and support when necessary.
Read more
they should. Diabetes self-management is the knowledge, skills and abilities necessary for the individual's self-care.
It is defined as the facilitation process (4,5). Competent and skilled in self-management individuals with diabetes can improve their health outcomes. American Diabetes Association (ADA), diabetes self-management education necessary for the self-care of people with diabetes.
take an individual-centered approach and make joint decisions to facilitate knowledge, skills and abilities It defines it as a process based on diagnosis, starting at the diagnosis stage and continuing (5).
The goal of diabetes self-management is to introduce new skills and abilities that support diabetes patients' self-management goals.
Developing behaviors and forming habits. General objectives of diabetes self-management education On the other hand, it enables individuals diagnosed with diabetes to make informed decisions, problem solving, personal care behavior, metabolic outcomes, health status and quality of life to improve (5). To strengthen the diabetes patient by providing self-management needs knowledge, skills and motivation about the disease. Counseling for nurses ability of the patient to adapt to his/her illness and self-care by doing and educating provides access (6). Coaching sessions to strengthen diabetes self-management and diabetes is applied. The coach is committed to maximizing the client's strengths, To ensure that it is used fully through continuous education, to be more effective, new to develop skills and activities, to be ready for new responsibilities, and to self-management.
It is the person who provides the necessary motivation (7). Life Coaching with Diabetes, about lifestyle with diabetes professional life coaching practices, aiming at behavior change in approaches (ICF-International Coaching Federation) is based on the basic principles and principles. life with diabetes coaching is used to help people who have been diagnosed with diabetes make the necessary changes in life through coaching.
to give practical applications. Walt Disney is a goal setting coaching exercise. The work consists of 6 steps. These steps it is as follows.
- Detection of the subject and 3 anchor methods
- Dreamer + Ground Anchor + Separator
- Planner + Ground Anchor + Separator
- Critic + Ground Anchor + Separator
- Brainstorming
- Metatest
Read the detailed description
Expected benefits:
Diabetes is a non-communicable disease that is increasing rapidly day by day. Providing support integrated with life coaching with diabetes will increase the awareness of people with diabetes and enable them to manage their diabetes.
- Developing appropriate self-care activities (physical activity, medical nutrition, drug management, avoiding risky behaviors, etc.) by improving the self-management skills of the individual with diabetes,
- The individual with diabetes becomes self-managing self-care practices,
- Improving decision-making and problem-solving skills of individuals with diabetes,
H0: Diabetes nurse coaching given to individuals with Type 2 Diabetes has no effect on HbA1c value and on strengthening diabetes.
H1: Diabetes nurse coaching given to individuals with Type 2 Diabetes has an effect on HbA1c value and strengthening diabetes.
The Universe of the Research The population of the study consists of patients with Type 2 Diabetes between the ages of 18-64 who applied to Ankara Pursaklar State Hospital Internal Medicine outpatient clinic.
Sample Selection of the Research The sample size was calculated using G*Power Software (ver. 3.1.9.7). The effect size was calculated by using the mean and standard deviation values of the last test of the experimental and control groups of the 'Diabetes strengthening scale' used in the randomized controlled study by Zamanzadeh (2017), the sample of the study. The sample size required for the study was calculated as 34 patients, 17 patients for each group, in the power analysis performed with 95% confidence level and 5% tolerance. However, it was aimed to reach 21 individuals from each group with the foresight that there may be participant losses during the study process. To avoid bias in assigning the individuals to be included in the study to the groups, https://randomizer.org/ With the help of the help of 1-42, random numbers were generated as 2 groups and the incoming individuals will be assigned to the relevant groups.
Data Collection Technique and Tools The data in the research will be collected through the data collection form, the diabetes empowerment scale, which was prepared based on the researcher's experiences and the literature.
- Data collection form: It will be created by the researcher based on the literature. (such as age, gender, how many years have had diabetes).
- Diabetes empowerment scale: The scale developed by Özcan and Korkmaz (2012); It has 3 sub-dimensions: management of psychosocial aspects in diabetes, level of dissatisfaction and readiness for change, setting and achieving diabetes goals.
- Conditions
- Nurse's Role, Diabetes Mellitus, Type 2
- Being tested
- nurse coaching
- Keywords
- walt disney, nurse coaching, nursing
- 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.
nurse coachingBehavioural
2 sessions of nurse coaching including the Walt Disney method will be applied to the participants.
| Study group | Role | What they receive |
|---|---|---|
| RESPONSE GROUP | Experimental | The study will be done online and the application will be explained to the patients. Randomly selected groups will be made using a single-blind technique, not knowing which group is the intervention group. Pre-test will be applied to the diabetic patients included in the experimental groups and control groups. After the preliminary tests are applied to the individuals with diabetes in the intervention 1 group, a nurse coaching interview will be held with diabetes by applying the 'walt disney' method. In accordance with the principles of coaching, 2 sessions will be held under the management of the patient. After the first session, 10 days later, in the second session, life coaching with diabetes will be done with the Walt Disney method. After 10 days after the 2nd interview, the final tests will be applied at the end of the 1st month. Receives: Behavioral: nurse coaching |
| control group | No intervention | The control group will be given a pre-test and a post-test 1 month later without any intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetes potentiation scale
It consists of 3 sub-dimensions including management of psychosocial aspects in diabetes, level of dissatisfaction and readiness for change, determination and achievement of diabetes goals, and 28 items in total. The highest possible score is 140 and the lowest score is 28. A high score from the scale indicates the strength of diabetes.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2023
- Study start1 May 2023
- Primary completion1 Jun 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nurse's RoleStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tuğba Bilgehan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Tuğba Bilgehan, Ankara Yildirim Beyazıt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05870293
- Sponsor's protocol ID
- TUGBABILGEHAN2
- Status last verified
- Jul 2023
- First submitted
- 12 May 2023
- Last updated
- 11 Jul 2023
- 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 11 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE EFFECT OF GOAL-SETTING DIABETES NURSE COACHING ON HbA1c VALUE AND STRENGTHENING DIABETES
- ClinicalTrials.gov ID
- NCT05870293
- Acronym / sponsor ID
- TUGBABILGEHAN2
- Conditions
- Nurse's Role, Diabetes Mellitus, Type 2
- Keywords
- walt disney, nurse coaching, nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Tuğba BilgehanUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 23 May 2023 (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.
American Diabetes Association and American Clinical Endocrinology American Association of Clinical Endocrinologists, treatment and care of individuals with diabetes in achieving their goals; regulation of nutrition, regulation of physical activity, pharmacological treatment, diabetes education, continuous monitoring and health checks should be done.
emphasizes (3,4). Individuals with diabetes receive diabetes self-management education and support when necessary.
they should. Diabetes self-management is the knowledge, skills and abilities necessary for the individual's self-care.
It is defined as the facilitation process (4,5). Competent and skilled in self-management individuals with diabetes can improve their health outcomes. American Diabetes Association (ADA), diabetes self-management education necessary for the self-care of people with diabetes.
take an individual-centered approach and make joint decisions to facilitate knowledge, skills and abilities It defines it as a process based on diagnosis, starting at the diagnosis stage and continuing (5).
The goal of diabetes self-management is to introduce new skills and abilities that support diabetes patients' self-management goals.
Developing behaviors and forming habits. General objectives of diabetes self-management education On the other hand, it enables individuals diagnosed with diabetes to make informed decisions, problem solving, personal care behavior, metabolic outcomes, health status and quality of life to improve (5). To strengthen the diabetes patient by providing self-management needs knowledge, skills and motivation about the disease. Counseling for nurses ability of the patient to adapt to his/her illness and self-care by doing and educating provides access (6). Coaching sessions to strengthen diabetes self-management and diabetes is applied. The coach is committed to maximizing the client's strengths, To ensure that it is used fully through continuous education, to be more effective, new to develop skills and activities, to be ready for new responsibilities, and to self-management.
It is the person who provides the necessary motivation (7). Life Coaching with Diabetes, about lifestyle with diabetes professional life coaching practices, aiming at behavior change in approaches (ICF-International Coaching Federation) is based on the basic principles and principles. life with diabetes coaching is used to help people who have been diagnosed with diabetes make the necessary changes in life through coaching.
to give practical applications. Walt Disney is a goal setting coaching exercise. The work consists of 6 steps. These steps it is as follows.
- Detection of the subject and 3 anchor methods
- Dreamer + Ground Anchor + Separator
- Planner + Ground Anchor + Separator
- Critic + Ground Anchor + Separator
- Brainstorming
- Metatest
Detailed description
Expected benefits:
Diabetes is a non-communicable disease that is increasing rapidly day by day. Providing support integrated with life coaching with diabetes will increase the awareness of people with diabetes and enable them to manage their diabetes.
- Developing appropriate self-care activities (physical activity, medical nutrition, drug management, avoiding risky behaviors, etc.) by improving the self-management skills of the individual with diabetes,
- The individual with diabetes becomes self-managing self-care practices,
- Improving decision-making and problem-solving skills of individuals with diabetes,
H0: Diabetes nurse coaching given to individuals with Type 2 Diabetes has no effect on HbA1c value and on strengthening diabetes.
H1: Diabetes nurse coaching given to individuals with Type 2 Diabetes has an effect on HbA1c value and strengthening diabetes.
The Universe of the Research The population of the study consists of patients with Type 2 Diabetes between the ages of 18-64 who applied to Ankara Pursaklar State Hospital Internal Medicine outpatient clinic.
Sample Selection of the Research The sample size was calculated using G*Power Software (ver. 3.1.9.7). The effect size was calculated by using the mean and standard deviation values of the last test of the experimental and control groups of the 'Diabetes strengthening scale' used in the randomized controlled study by Zamanzadeh (2017), the sample of the study. The sample size required for the study was calculated as 34 patients, 17 patients for each group, in the power analysis performed with 95% confidence level and 5% tolerance. However, it was aimed to reach 21 individuals from each group with the foresight that there may be participant losses during the study process. To avoid bias in assigning the individuals to be included in the study to the groups, https://randomizer.org/ With the help of the help of 1-42, random numbers were generated as 2 groups and the incoming individuals will be assigned to the relevant groups.
Data Collection Technique and Tools The data in the research will be collected through the data collection form, the diabetes empowerment scale, which was prepared based on the researcher's experiences and the literature.
- Data collection form: It will be created by the researcher based on the literature. (such as age, gender, how many years have had diabetes).
- Diabetes empowerment scale: The scale developed by Özcan and Korkmaz (2012); It has 3 sub-dimensions: management of psychosocial aspects in diabetes, level of dissatisfaction and readiness for change, setting and achieving diabetes goals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RESPONSE GROUP | Experimental | Behavioral: nurse coachingThe study will be done online and the application will be explained to the patients. Randomly selected groups will be made using a single-blind technique, not knowing which group is the intervention group. Pre-test will be applied to the diabetic patients included in the experimental groups and control groups. After the preliminary tests are applied to the individuals with diabetes in the intervention 1 group, a nurse coaching interview will be held with diabetes by applying the 'walt disney' method. In accordance with the principles of coaching, 2 sessions will be held under the management of the patient. After the first session, 10 days later, in the second session, life coaching with diabetes will be done with the Walt Disney method. After 10 days after the 2nd interview, the final tests will be applied at the end of the 1st month. |
| control group | No intervention | –The control group will be given a pre-test and a post-test 1 month later without any intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Who voluntarily agrees to participate in the study,
Key exclusion criteria (2 listed)
- not attending the coaching interview
- unwillingness to quit
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 |
|---|---|---|
| nurse coaching2 sessions of nurse coaching including the Walt Disney method will be applied to the participants. | Behavioural | RESPONSE GROUP |
Primary outcome
Diabetes potentiation scale
Time frame: 1 month
It consists of 3 sub-dimensions including management of psychosocial aspects in diabetes, level of dissatisfaction and readiness for change, determination and achievement of diabetes goals, and 28 items in total. The highest possible score is 140 and the lowest score is 28. A high score from the scale indicates the strength of diabetes.
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 11 Jul 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nurse coaching in people with Nurse's Role and Diabetes Mellitus, Type 2, run by Tuğba Bilgehan 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 7 inclusion and 2 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 11 Jul 2023. 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?
Diabetes potentiation scale (time frame: 1 month). 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 11 Jul 2023.