Diabetes Mellitus, Type 2NCT06265181
The Effect of Diabetes Coaching on Distress and Diabetes Self-Management
A study testing Diabetes coaching in people with Diabetes Mellitus, Type 2, run by Abant Izzet Baysal University.
Trial summary
This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes. The research is planned to start on 01.01.2024. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Diabetes coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 27 Mar 2024to 31 Dec 2027
- 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
- Volunteering to participate in the study,
- Having been diagnosed with Type 2 diabetes for at least 1 year,
- Being between the ages of 18-65,
- No communication problems,
- Being literate,
- Being able to use a phone (home or mobile phone),
Show all 9Show fewer
- Lack of diagnosis of psychiatric disease,
- Not receiving hospital treatment due to acute problems,
- Not to be involved in another study involving a similar intervention during the research period
Who cannot join
- Being diagnosed with type 1 diabetes,
- Type 2 diabetes diagnosis period is less than one year,
- Being under 18 years of age, over 65 years of age,
- Being pregnant,
- Having a diagnosis of psychiatric disease,
- Not agreeing to participate in the research
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: Effect Of Diabetes Coaching on Diabetes Self-Management, Glycoslated Hemoglobin and Diabetes Distress Level in Indıviduals With Type 2 Diabetes: A Randomized Controlled Study
This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes.
The research is planned to start on 01.01.2024. Participants will be divided into experimental and control groups using the block randomization method. Participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. No intervention will be made to the control group. The preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. Data will be collected by face-to-face interview method. Data will be analyzed with IBM SPSS V23 program.
Read the detailed description
Diabetes is a chronic and metabolic disease that develops when the body cannot secrete enough insulin or the cells cannot use insulin as they should, causing damage to many tissues and organs. It is estimated that there are 537 million adults aged 20-79 in the world with diabetes and this number will reach 783 million in 2045.
Diabetes distress, which is one of the most common mental concerns in individuals with diabetes, makes it difficult to achieve glycemic control, paves the way for the development of diabetes complications and reduces the quality of life. Diabetes distress also causes an increase in the risk of mortality and morbidity. One of the best ways to prevent or reduce diabetes distress is to provide self-management skills and support.
In recent years, health coaching has attracted attention in many countries for improving patients' self-management and providing the necessary behavioral change.
In this study, the effect of coaching intervention applied to individuals with diabetes on diabetes self-management, HbA1c and diabetes distress will be investigated.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Diabetes coaching
- Keywords
- Diabetes, Coaching, Self Management, Diabetes Distress
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes coachingBehavioural
Diabetes coaching intervention will be provided to the participants in the intervention group by the researcher, who is a specialist nurse who has received 140 hours of Level 2 Professional Coaching Training and 20 hours of diabetes coaching training. Since each individual's needs and values will be different, diabetes coaching interventions will be tailored specifically to the individual by the researcher within the general coaching framework, but by taking into account the individual's views, awareness, needs and current situation regarding self-management regarding diabetes. This flexibility, which supports the individual-specific approach within the coaching paradigm, is among the key elements in the success of coaching interventions (43). The individual will determine the coaching agenda according to his/her own needs.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Diabetes coaching will be provided to experimental group participants. In this study, one chemistry interview and eight diabetes coaching meetings are planned to be held.
Interviews will be conducted in accordance with the standards of the GROW technique, which is based on a scientific framework. Interviews will be held every 10 days, via a video-free phone call, and will last between 45-60 minutes. Receives: Behavioral: Diabetes coaching |
| Control Group | No intervention | Diabetes treatment and care of the participants in this group will continue routinely, and no additional intervention will be performed. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Type 2 Diabetes Self-Management Scale
This scale was developed by Koç and Özkan to evaluate self-management in type 2 diabetics and is a 5-point Likert type ("Always=5", "Often=4", "Sometimes=3") , "Rarely=2", "Never=1"). The sub-dimensions of the scale, which consists of a total of 19 questions; "Healthy Lifestyle Behaviors" (11 items), "Use of Health Services" (4 items) and "Blood Sugar Management" (4 items). The highest score that can be obtained from the scale is 95 and the lowest score is 19. As the score obtained from the scale increases, diabetes self-management increases. The Cronbach alpha value of the scale was calculated as 0.856 (37)
Measured: 3 months
Secondary outcomes (3)
Diabetes Distress Scale
The Diabetes Distress Scale is a 17-item, 6-point Likert type scale developed by Polonsky et al. in 2005 to evaluate diabetes-specific distress. The scale consists of four subscales: emotional burden, doctor-related distress, treatment-related distress, and interpersonal distress. Each question in the scale is scored between 1 point and 6 points, and the scale evaluates the distress experienced by the individual in the last month (40). The validity and reliability study of the scale was conducted by Çakıllı et al. in 2015, and the α value was found to be 0.88 for the entire scale and 0.90 for each of the subscales. The average total score of the scale is calculated by dividing the total score of the answers given to the scale by 17. A score of 3 points or higher suggests the presence of distress. Score calculation for the sub-dimensions is obtained by dividing the total score of the answers given to the questions by the number of questions in that section (40,41)
Measured: 3 months
HbA1c Monitoring Form
This is the form created to monitor the HbA1c values of individuals with diabetes before and after the application and to follow the changes (Annex 3). HbA1c is a routine test evaluated every three months in the follow-up of individuals with diabetes. Individuals will be included in the study if they have HbA1c tests within the last 10 days when they come to the Family Health Care, otherwise they will be included in the study when they have the test done on a date suitable for routine control.
Measured: 3 months
Introductory Features Form
The form was prepared by the researcher by conducting a literature review and consists of a total of 23 questions (32,34,37-39). In this form, in the first section; Questions about age, gender, education level, marital status, perceived income level, who the individual lives with, smoking and alcohol use, and the presence of chronic diseases. In the second part, there are questions about diabetes; duration of diabetes diagnosis, type of diabetes treatment, status of receiving diabetes education, HbA1c value measured in the last 10 days, presence and types of complications due to diabetes, regular use of diabetes medications, how diabetes care is carried out, status of receiving diabetes education (from whom, training subject , when it was taken, etc.) are included
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2024
- Study start27 Mar 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Abant Izzet Baysal 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental and control group.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abant Izzet Baysal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saadet Can Çiçek, Abant Izzet Baysal University
- Investigators
- Saadet CAN ÇİÇEK, Assoc Prof., Principal investigator, Abant Izzet Baysal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06265181
- Sponsor's protocol ID
- AIBU-SBF-SK-04
- Status last verified
- Feb 2024
- First submitted
- 4 Feb 2024
- Last updated
- 20 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 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Diabetes Coaching on Diabetes Self-Management, Glycoslated Hemoglobin and Diabetes Distress Level in Indıviduals With Type 2 Diabetes: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06265181
- Acronym / sponsor ID
- AIBU-SBF-SK-04
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Diabetes, Coaching, Self Management, Diabetes Distress
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 64 participants (estimated)
- Lead sponsor
- Abant Izzet Baysal UniversityUniversity, hospital or other
- Study start
- 27 Mar 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 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.
This research is a randomized controlled, experimental study planned to evaluate the effect of diabetes coaching on diabetes self-management, glycosylated hemoglobin and diabetes distress levels in individuals with type 2 diabetes.
The research is planned to start on 01.01.2024. Participants will be divided into experimental and control groups using the block randomization method. Participants in the experimental group will first receive 8 sessions of diabetes coaching every 10 days after the chemistry interview. No intervention will be made to the control group. The preliminary implementation of the research will be carried out with 4 individuals with diabetes who voluntarily accept participation and meet the inclusion criteria. Data will be collected by face-to-face interview method. Data will be analyzed with IBM SPSS V23 program.
Detailed description
Diabetes is a chronic and metabolic disease that develops when the body cannot secrete enough insulin or the cells cannot use insulin as they should, causing damage to many tissues and organs. It is estimated that there are 537 million adults aged 20-79 in the world with diabetes and this number will reach 783 million in 2045.
Diabetes distress, which is one of the most common mental concerns in individuals with diabetes, makes it difficult to achieve glycemic control, paves the way for the development of diabetes complications and reduces the quality of life. Diabetes distress also causes an increase in the risk of mortality and morbidity. One of the best ways to prevent or reduce diabetes distress is to provide self-management skills and support.
In recent years, health coaching has attracted attention in many countries for improving patients' self-management and providing the necessary behavioral change.
In this study, the effect of coaching intervention applied to individuals with diabetes on diabetes self-management, HbA1c and diabetes distress will be investigated.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Experimental and control group.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Diabetes coachingDiabetes coaching will be provided to experimental group participants. In this study, one chemistry interview and eight diabetes coaching meetings are planned to be held. Interviews will be conducted in accordance with the standards of the GROW technique, which is based on a scientific framework. Interviews will be held every 10 days, via a video-free phone call, and will last between 45-60 minutes. |
| Control Group | No intervention | –Diabetes treatment and care of the participants in this group will continue routinely, and no additional intervention will be performed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Volunteering to participate in the study,
- Having been diagnosed with Type 2 diabetes for at least 1 year,
- Being between the ages of 18-65,
- No communication problems,
- Being literate,
Key exclusion criteria (6 listed)
- Being diagnosed with type 1 diabetes,
- Type 2 diabetes diagnosis period is less than one year,
- Being under 18 years of age, over 65 years of age,
- Being pregnant,
- Having a diagnosis of psychiatric disease,
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 |
|---|---|---|
| Diabetes coachingDiabetes coaching intervention will be provided to the participants in the intervention group by the researcher, who is a specialist nurse who has received 140 hours of Level 2 Professional Coaching Training and 20 hours of diabetes coaching training. Since each individual's needs and values will be different, diabetes coaching interventions will be tailored specifically to the individual by the researcher within the general coaching framework, but by taking into account the individual's views, awareness, needs and current situation regarding self-management regarding diabetes. This flexibility, which supports the individual-specific approach within the coaching paradigm, is among the key elements in the success of coaching interventions (43). The individual will determine the coaching agenda according to his/her own needs. | Behavioural | Intervention Group |
Primary outcome
Type 2 Diabetes Self-Management Scale
Time frame: 3 months
This scale was developed by Koç and Özkan to evaluate self-management in type 2 diabetics and is a 5-point Likert type ("Always=5", "Often=4", "Sometimes=3") , "Rarely=2", "Never=1"). The sub-dimensions of the scale, which consists of a total of 19 questions; "Healthy Lifestyle Behaviors" (11 items), "Use of Health Services" (4 items) and "Blood Sugar Management" (4 items). The highest score that can be obtained from the scale is 95 and the lowest score is 19. As the score obtained from the scale increases, diabetes self-management increases. The Cronbach alpha value of the scale was calculated as 0.856 (37)
3 secondary outcomes
Diabetes Distress Scale
Time frame: 3 months
HbA1c Monitoring Form
Time frame: 3 months
Introductory Features Form
Time frame: 3 months
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 20 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.
Saadet CAN ÇİÇEK, Assoc Prof. principal investigator
Abant Izzet Baysal University
Questions about this trial
What is this clinical trial studying?
A study testing Diabetes coaching in people with Diabetes Mellitus, Type 2, run by Abant Izzet Baysal 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 9 inclusion and 6 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 20 Feb 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 Sinem KURTOĞLU, Phd Student (90 374 253 45 20, sinem.nehirrr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Type 2 Diabetes Self-Management Scale (time frame: 3 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 20 Feb 2024.