Nurse's RoleNCT05870280
Nurse Coaching the Effect of on Glycemic Control, Fear of Hypoglycemia and Risk Perception in Adults With Type 1 Diabetes.
A study testing nurse coaching in people with Nurse's Role and Diabetes Mellitus, run by Tuğba Bilgehan at 1 site in Turkey (Türkiye).
Trial summary
Because of the unforeseen rate of increase in case numbers, the high rates of mortality and morbidity, and the increased socio economic load it causes, diabetes has become the most discussed chronic and widespread metabolic disease in Turkey, and throughout the World, there are focused efforts to find a solution. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nurse's Role, Diabetes Mellitus, Hypoglycemia
- 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
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Aug 2023to 30 Oct 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
- The patient;
- Being between the ages of 18-65,
- Having a smart phone and being able to use it actively,
- Having been diagnosed with type 1 diabetes at least 1 year ago,
- HbA1c > 7,
- Absence of any psychiatric or mental problems,
Show all 9Show fewer
- Having the cognitive competence to answer the questions,
- Being able to speak, understand and read and write Turkish
- Patients who voluntarily agreed to participate in the study were included in the study.
Who cannot join
- individual not participating in more than one interview
- unwillingness to quit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nurse Coaching Given According to Integrative Nurse Coaching Theory the Effect of on Glisemic Control, Fear of Hypoglycemia and Risk Perception in Adults With Type 1 Diabetes.
Because of the unforeseen rate of increase in case numbers, the high rates of mortality and morbidity, and the increased socio economic load it causes, diabetes has become the most discussed chronic and widespread metabolic disease in Turkey, and throughout the World, there are focused efforts to find a solution. It is very important for a person to self-assesss and evaluate to draw a roadmap for improved outcomes in a disease with a high financial and moral burden. A nurse is not only a caregiver to patients, but also a person who guides them to increased engagement and motivation in the care of their illness. Integrative Nurse Coaching is gaining notoriaty as an effective method to improve patient engagament and motivation in self-responsibility for health. The Integrative Nurse Coach Academy in the USA carries out studies and trainings to further this improvement. With cooperation between United States and Turkish nurse colleagues, it aims to bring Integrative Nurse Coach practice to Turkey. The Integrative Nurse Coach uses the nursing process as a framework to guide nurse coaching practice. This requires a shift in traditional nursing terminology and meaning to understand and incorporate the patient's subjective experience as follows: from assessment to stablishing a relationship, identifying readiness for change and the resources available to the patient for change; from nursing diagnosis to identifying opportunities and issues; from outcomes to having the patient set the agenda for achievement of the patient's goals; from 3 planning to creating the structure of the coaching interaction; from intervention to empowering the patient to reach goals; and from evaluating to assisting the patient to determine the extent to which goals were achieved.
The Theory of Integrative Nurse Coaching (TINC) , developed by the Integrative Nurse Coach Association , sheds light on this point. The TINC encompasses many holistic nursing theories and contains three concepts and five components. The three concepts are healing, metaparadigm in nursing theory (nurse, person, health, environment), and patterns of knowing in nursing (personal, empirics, aesthetics, ethical, not knowing, sociopolitical. The TINC five components include Integrative Nurse Coach Self-Development (self-reflection, self-assessment, self-evaluation self-care), Integral Perspective and Change, Integrative Lifestyle Health and Well-Being, Awareness and Choice, and Listening With Heart The five components all have equal value and form the basis for the nurse coach professional practice model. There is a parallel process of self-development for both the nurse coach and the client. The SelfDevelopment component empowers individuals (including the nurse coach) to focus on their health and wellness from an integral perspective and to identify their individual knowledge, expertise, strengths, and resources, while recognizing the fluidity of the change. The TINC is designed to guide nurse coaching practice, education, research, and health care policy. The theory emphasizes, describes, and directs the practice of nurse coaching, a recognized holistic nursing modality. It has been seen that the TINC framework is very suitable for individuals with diabetes to provide their own management.
Read the detailed description
This research is a quasi-experimental study in pretest-posttest design research; It will be conducted with individuals with Type 1 diabetes who applied to Ankara City Hospital Endocrine Polyclinic. The sample size required for the study was found to be 95% power at 95% confidence level and 35 individuals for high-level effect size (f=0.40). However, the aim is to reach 40 individuals with the thought that data loss may occur during the study process.
Inclusion Criteria for Research; The patient;
- Being between the ages of 18-65,
- Having a smart phone and being able to use it actively,
- Having been diagnosed with type 1 diabetes at least 1 year ago,
- HbA1c > 7,
- Absence of any psychiatric or mental problems,
- Having the cognitive competence to answer the questions,
- Being able to speak, understand and read and write Turkish
- Patients who voluntarily agreed to participate in the study were included in the study.
Hypotesis H0: Nurse coaching given to individuals with Type 1 Diabetes has no effect on glycemic control, fear of hypoglycemia, and risk perception.
H1: Nurse coaching given to individuals with Type 1 Diabetes has an effect on glycemic control, fear of hypoglycemia and risk perception.
Data collection tools Data will be collected through the Sociodemographic data collection form, the hypoglycemıc attıtudes and behavıor scale, the risk perception scale.
Sociodemographic data collection form:
The form created by the researcher consists of questions about the sociodemographic information of the individual. In this section, besides questions about diabetes, there are questions such as gender, weight, height, age, marital status, educational status, occupation, economic status, and place of residence. The hypoglycemıc attıtudes and behavıor scale: The scale was developed by Polonsky. The 14-item 5-point Likert-type scale has 3 sub-dimensions. Anxiety, confidence, avoidance. The score of the sub-dimensions is calculated by dividing the number of items.
The risk perception scale: The scale was developed in 2007 and tested for validity and reliability. The scale is a self-report scale with 31 items that is easy to complete. Items 8,9,10,11,12, and 13 are scored inversely on the scale. The scale has 2 sub dimensions, namely risk knowledge and composite risk. These sub dimensions are evaluated separately in the scale and the total score from the scale is calculated through their total. The scores of the sub dimensions are calculated through dividing the total score by the number of items in the sub dimension.
- Conditions
- Nurse's Role, Diabetes Mellitus, Hypoglycemia
- Being tested
- nurse coaching
- Keywords
- nurse coaching, diabetes, nursing
- Medical subject headings
- Diabetes Mellitus, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nurse coachingBehavioural
Group coaching will be applied to individuals with diabetes, 5-8 people.
| Study group | Role | What they receive |
|---|---|---|
| RESPONSE GROUP | Experimental | After signing the voluntary consent form, the participants will be filled in the socio-demographic data collection form, the hypoglycemic attudes and behavior scale, the risk perception scale. A total of 4 group nurse coaching meetings will be held with individuals with type 1 diabetes, one to one over 7 days, under the framework of Theory of Integrative Nurse Coaching. Each of these interviews will last an average of 40-60 minutes. Interviews will be held online through the Zoom® webconferencing program at times scheduled jointly with the client. After the coaching meetings are over, the scales will be filled again and the HbA1c level will be requested from the blood results ordered at the doctor's request. In the coaching interviews, the materials specific to the coaching training received by the researchers (techniques such as the wheel of life, imagination, sabotage work, strong questions, Cartesian questions, SWOT analysis) will be used. Receives: Behavioral: nurse coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
The hypoglycemıc attıtudes and behavıor
The 14-item 5-point Likert-type scale has 3 sub-dimensions. Anxiety, trust, avoidance. The score of the sub-dimensions is calculated by dividing the number of items.The highest score that can be obtained is 70 and the lowest score is 14.
Measured: 1 month
Secondary outcomes (1)
The risk perception
The scale is a self-report scale with 31 items that is easy to complete. Items 8,9,10,11,12, and 13 are scored inversely on the scale. The scale has 2 sub dimensions, namely risk knowledge and composite risk. These sub dimensions are evaluated separately in the scale and the total score from the scale is calculated through their total. The scores of the sub dimensions are calculated through dividing the total score by the number of items in the sub dimension.
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 start30 Aug 2023 (estimated)
- Primary completion30 Sep 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
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
- NCT05870280
- Sponsor's protocol ID
- TUGBABILGEHAN1
- Status last verified
- Jul 2023
- First submitted
- 12 May 2023
- Last updated
- 10 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nurse Coaching Given According to Integrative Nurse Coaching Theory the Effect of on Glisemic Control, Fear of Hypoglycemia and Risk Perception in Adults With Type 1 Diabetes.
- ClinicalTrials.gov ID
- NCT05870280
- Acronym / sponsor ID
- TUGBABILGEHAN1
- Conditions
- Nurse's Role, Diabetes Mellitus, Hypoglycemia
- Keywords
- nurse coaching, diabetes, nursing
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Tuğba BilgehanUniversity, hospital or other
- Study start
- 30 Aug 2023 (estimated)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- 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.
Because of the unforeseen rate of increase in case numbers, the high rates of mortality and morbidity, and the increased socio economic load it causes, diabetes has become the most discussed chronic and widespread metabolic disease in Turkey, and throughout the World, there are focused efforts to find a solution. It is very important for a person to self-assesss and evaluate to draw a roadmap for improved outcomes in a disease with a high financial and moral burden. A nurse is not only a caregiver to patients, but also a person who guides them to increased engagement and motivation in the care of their illness. Integrative Nurse Coaching is gaining notoriaty as an effective method to improve patient engagament and motivation in self-responsibility for health. The Integrative Nurse Coach Academy in the USA carries out studies and trainings to further this improvement. With cooperation between United States and Turkish nurse colleagues, it aims to bring Integrative Nurse Coach practice to Turkey. The Integrative Nurse Coach uses the nursing process as a framework to guide nurse coaching practice. This requires a shift in traditional nursing terminology and meaning to understand and incorporate the patient's subjective experience as follows: from assessment to stablishing a relationship, identifying readiness for change and the resources available to the patient for change; from nursing diagnosis to identifying opportunities and issues; from outcomes to having the patient set the agenda for achievement of the patient's goals; from 3 planning to creating the structure of the coaching interaction; from intervention to empowering the patient to reach goals; and from evaluating to assisting the patient to determine the extent to which goals were achieved.
The Theory of Integrative Nurse Coaching (TINC) , developed by the Integrative Nurse Coach Association , sheds light on this point. The TINC encompasses many holistic nursing theories and contains three concepts and five components. The three concepts are healing, metaparadigm in nursing theory (nurse, person, health, environment), and patterns of knowing in nursing (personal, empirics, aesthetics, ethical, not knowing, sociopolitical. The TINC five components include Integrative Nurse Coach Self-Development (self-reflection, self-assessment, self-evaluation self-care), Integral Perspective and Change, Integrative Lifestyle Health and Well-Being, Awareness and Choice, and Listening With Heart The five components all have equal value and form the basis for the nurse coach professional practice model. There is a parallel process of self-development for both the nurse coach and the client. The SelfDevelopment component empowers individuals (including the nurse coach) to focus on their health and wellness from an integral perspective and to identify their individual knowledge, expertise, strengths, and resources, while recognizing the fluidity of the change. The TINC is designed to guide nurse coaching practice, education, research, and health care policy. The theory emphasizes, describes, and directs the practice of nurse coaching, a recognized holistic nursing modality. It has been seen that the TINC framework is very suitable for individuals with diabetes to provide their own management.
Detailed description
This research is a quasi-experimental study in pretest-posttest design research; It will be conducted with individuals with Type 1 diabetes who applied to Ankara City Hospital Endocrine Polyclinic. The sample size required for the study was found to be 95% power at 95% confidence level and 35 individuals for high-level effect size (f=0.40). However, the aim is to reach 40 individuals with the thought that data loss may occur during the study process.
Inclusion Criteria for Research; The patient;
- Being between the ages of 18-65,
- Having a smart phone and being able to use it actively,
- Having been diagnosed with type 1 diabetes at least 1 year ago,
- HbA1c > 7,
- Absence of any psychiatric or mental problems,
- Having the cognitive competence to answer the questions,
- Being able to speak, understand and read and write Turkish
- Patients who voluntarily agreed to participate in the study were included in the study.
Hypotesis H0: Nurse coaching given to individuals with Type 1 Diabetes has no effect on glycemic control, fear of hypoglycemia, and risk perception.
H1: Nurse coaching given to individuals with Type 1 Diabetes has an effect on glycemic control, fear of hypoglycemia and risk perception.
Data collection tools Data will be collected through the Sociodemographic data collection form, the hypoglycemıc attıtudes and behavıor scale, the risk perception scale.
Sociodemographic data collection form:
The form created by the researcher consists of questions about the sociodemographic information of the individual. In this section, besides questions about diabetes, there are questions such as gender, weight, height, age, marital status, educational status, occupation, economic status, and place of residence. The hypoglycemıc attıtudes and behavıor scale: The scale was developed by Polonsky. The 14-item 5-point Likert-type scale has 3 sub-dimensions. Anxiety, confidence, avoidance. The score of the sub-dimensions is calculated by dividing the number of items.
The risk perception scale: The scale was developed in 2007 and tested for validity and reliability. The scale is a self-report scale with 31 items that is easy to complete. Items 8,9,10,11,12, and 13 are scored inversely on the scale. The scale has 2 sub dimensions, namely risk knowledge and composite risk. These sub dimensions are evaluated separately in the scale and the total score from the scale is calculated through their total. The scores of the sub dimensions are calculated through dividing the total score by the number of items in the sub dimension.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RESPONSE GROUP | Experimental | Behavioral: nurse coachingAfter signing the voluntary consent form, the participants will be filled in the socio-demographic data collection form, the hypoglycemic attudes and behavior scale, the risk perception scale. A total of 4 group nurse coaching meetings will be held with individuals with type 1 diabetes, one to one over 7 days, under the framework of Theory of Integrative Nurse Coaching. Each of these interviews will last an average of 40-60 minutes. Interviews will be held online through the Zoom® webconferencing program at times scheduled jointly with the client. After the coaching meetings are over, the scales will be filled again and the HbA1c level will be requested from the blood results ordered at the doctor's request. In the coaching interviews, the materials specific to the coaching training received by the researchers (techniques such as the wheel of life, imagination, sabotage work, strong questions, Cartesian questions, SWOT analysis) will be used. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- The patient;
- Being between the ages of 18-65,
- Having a smart phone and being able to use it actively,
- Having been diagnosed with type 1 diabetes at least 1 year ago,
- HbA1c > 7,
Key exclusion criteria (2 listed)
- individual not participating in more than one 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 coachingGroup coaching will be applied to individuals with diabetes, 5-8 people. | Behavioural | RESPONSE GROUP |
Primary outcome
The hypoglycemıc attıtudes and behavıor
Time frame: 1 month
The 14-item 5-point Likert-type scale has 3 sub-dimensions. Anxiety, trust, avoidance. The score of the sub-dimensions is calculated by dividing the number of items.The highest score that can be obtained is 70 and the lowest score is 14.
1 secondary outcome
The risk perception
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2023.
- Individual participant dataSharing planned: Undecided
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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, 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 9 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: status not confirmed, as of the sponsor's last update on 10 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?
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?
The hypoglycemıc attıtudes and behavıor (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 10 Jul 2023.