Diabetes Mellitus, Type 2NCT05544435
Motivational Interviewing on Self-Care Activities in T2DM: The Sample of Turkey
A study testing Motivational İnterviewing in people with Diabetes Mellitus, Type 2, run by Erzurum Technical University at 1 site in Turkey (Türkiye).
Trial summary
Purpose:This study aims to research the effects of motivational interviewing on self-care activities in patients with type 2 diabetes. Design and Method:This study is a quasi-experimental clinical research with pre-test post-test comparison.12 sessions were held in 3 months in the experimental group with motivational… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Motivational İnterviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 25 Sep 2019to 30 May 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 and older
- Diagnosed with T2DM at least six months ago
- To be literate
- Living in the city centre
- HbA1c value of 6.5% or higher
- Speak Turkish.
Who cannot join
- Having any psychiatric disease and mental problems
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Erzurum Technical University Faculty
Erzurum, 25050
About this study
Official title: The Efficacy of Motivational Interviewing on Self-Care Activities in The Management of Type 2 Diabetes Mellitus: The Sample of Turkey
Purpose:This study aims to research the effects of motivational interviewing on self-care activities in patients with type 2 diabetes.
Design and Method:This study is a quasi-experimental clinical research with pre-test post-test comparison.12 sessions were held in 3 months in the experimental group with motivational interviewing method.
Read more
Findings:After a 3-month follow up, while a significant improvement was observed in post-intervention self-care activities in the experimental group, a significant decrease was observed in all self-care activities except foot care in the control group.
Practice Implications:Motivational interviewing intervention can be used to develop self-care activities in type 2 diabetes patients, especially to guide diabetes nurses.
Read the detailed description
This study is a quasi-experimental clinical research with pre-test post-test comparison. Population of the study consists of patients who referred to internal medicine outpatient clinic and clinics of a state hospital and who were diagnosed with T2DM between September 2019 and May 2020. The study was initiated with 60 patients who were aged 18 and older, diagnosed with T2DM at least 6 months ago, literate, living in city centre and with a HbA1c value of 6.5% or higher. These patients were described as potential participants by the researchers and experimental (30 patients) and control (30 patients) groups were formed by using simple random numbers table. The participants were explained about the aim of the study and oral and written permissions were taken. During the study period, 6 patients in the experimental group and 3 patients in the control group left the study for various reasons and the study was ended with 51 patients. In data collection, patient information form prepared by the researchers (age, gender, marital status, educational status, disease duration, presence of another chronic disease and smoking status), metabolic variable values (HbA1c and fasting blood sugar) and Summary of diabetes self-care activities scale (SDSCA) developed by Toobert and Glaskow (1994) and revised in 2000 (D.J. Toobert et al., 2000) were used. Summary of diabetes self-care activities scale consists of subscales such as patient diet, exercise, blood sugar test, foot care and smoking. As a result of the calculation of scores, high scores indicate that patients can fulfil self-care behaviors. After the initial data were collected, the patients in the experimental group were given appointments by the researcher for MI intervention. No intervention was performed on the control group participants and they were given appointment for post-test application three months later.
2.1. Intervention In addition to the care they always received, MI sessions were conducted by the researcher for the participants in the experimental group. This intervention was conducted as 30-45 minutes of 12 sessions in total for each patient for a period of 3 months by the academic nurse. In these sessions, the agenda was created in accordance with the nature of MI intervention, efforts were made to resolve the ambivalent feelings in the patient, the patient's change phase was determined, the patient's self-confidence for change was determined, it was questioned how much the patient cared for change and the patient was helped in determining the change plan. In addition, during the sessions, the problems patients experienced about self-care activities, the causes of these problems and the barriers in maintaining self-care activities were discussed and efforts were made to create awareness in patients.
In each MI session;
- Opening and structuring; Meeting, information was given about our role and goals in the study, how much time the investigators have, the role of the counselee and about there will be detailed questions during the study and the session was opened with the question What is on your mind?'
- Creating agenda: What are the investigators going to talk about today? (What would participants like to talk about today, having your blood sugar measured, eating healthily, getting your medication or exercising/Maybe there is something else?)
- Decision balance: Conflict was created in individuals by asking them to compare their existing healthcare behaviors and ideal/desired healthcare behaviors.
- Determining significance and confidence: How important is it for participants to fulfil self-care activities? How much confidence do participants have in yourself about this?
- Change plan: After decision balance was established, its suitability for patients was evaluated, at the end of the session, an action (change) plan was created for the desired behavior change and the session was closed by determining the next interview day-hour.
In the last MI session:
- The session was opened by summarizing the previous interview.
- A general discussion was made on change.
- Individuals' self-care activities were evaluated (The Summary of Diabetes Self-Care)
- Appointment was made from the hospital for individuals to have their glycemic values measured and the values were recorded (glycemic laboratory results).
- Closing.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Motivational İnterviewing
- Keywords
- Motivational İnterviewing, Nursing, Self-caring activities, Turkey
- 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.
Motivational İnterviewingBehavioural
Motivational Interviewing (MI), which is one of these methods, is an individual-based counselling approach that can easily be used by nurses who have been trained to help the management of disease in chronic diseases (Berhe et al., 2020; Kızılırmak \& Demir, 2018; Maslakpak et al., 2020). The core principles of MI includes expressing empathy by providing acceptance and understanding, realizing inconsistencies, avoiding discussions and supporting self-efficacy (Matinolli et al., 2012). The main purpose of MI is to identify the ambivalent emotions that occur in the patient in health-related activities, to strengthen and encourage insights of patients by supporting healthy lifestyle changes and self-confidence (R.Miller \& Rollnick, 2013). Because of its flexibility and ability to be applied in different behavioural aspects, MI can be administered individually and in groups by trained individuals (Maslakpak et al., 2020).
| Study group | Role | What they receive |
|---|---|---|
| Motivational Interviewing | Experimental | Intervention In addition to the care they always received, MI sessions were conducted by the researcher for the participants in the experimental group. This intervention was conducted as 30-45 minutes of 12 sessions in total for each patient for a period of 3 months by the academic nurse. In these sessions, the agenda was created in accordance with the nature of MI intervention, efforts were made to resolve the ambivalent feelings in the patient, the patient's change phase was determined, the patient's self-confidence for change was determined, it was questioned how much the patient cared for change and the patient was helped in determining the change plan. In addition, during the sessions, the problems patients experienced about self-care activities, the causes of these problems and the barriers in maintaining self-care activities were discussed and efforts were made to create awareness in patients. Receives: Behavioral: Motivational İnterviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Summary of diabetes self-care activities scale (SDSCA)
Summary of diabetes self-care activities scale consists of patient diet, exercise, blood sugar test, foot care and smoking.
Measured: 3 months after the start of the study
Secondary outcomes (1)
Metabolic variable values
HbA1c and fasting blood sugar
Measured: 3 months after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2022
- Study start25 Sep 2019
- Primary completion30 May 2020
- Study completion30 May 2020
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.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erzurum Technical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elanur Uludağ, Dr., Principal investigator, Erzurum Technical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05544435
- Sponsor's protocol ID
- ETÜ--ULUDAĞ---001
- Status last verified
- Sep 2022
- First submitted
- 1 Sep 2022
- Last updated
- 16 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Motivational Interviewing on Self-Care Activities in The Management of Type 2 Diabetes Mellitus: The Sample of Turkey
- ClinicalTrials.gov ID
- NCT05544435
- Acronym / sponsor ID
- ETÜ--ULUDAĞ---001
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Motivational İnterviewing, Nursing, Self-caring activities, Turkey
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Erzurum Technical UniversityUniversity, hospital or other
- Study start
- 25 Sep 2019 (actual)
- Primary completion
- 30 May 2020 (actual)
- Study completion
- 30 May 2020 (actual)
- First posted
- 16 Sep 2022 (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.
Purpose:This study aims to research the effects of motivational interviewing on self-care activities in patients with type 2 diabetes.
Design and Method:This study is a quasi-experimental clinical research with pre-test post-test comparison.12 sessions were held in 3 months in the experimental group with motivational interviewing method.
Findings:After a 3-month follow up, while a significant improvement was observed in post-intervention self-care activities in the experimental group, a significant decrease was observed in all self-care activities except foot care in the control group.
Practice Implications:Motivational interviewing intervention can be used to develop self-care activities in type 2 diabetes patients, especially to guide diabetes nurses.
Detailed description
This study is a quasi-experimental clinical research with pre-test post-test comparison. Population of the study consists of patients who referred to internal medicine outpatient clinic and clinics of a state hospital and who were diagnosed with T2DM between September 2019 and May 2020. The study was initiated with 60 patients who were aged 18 and older, diagnosed with T2DM at least 6 months ago, literate, living in city centre and with a HbA1c value of 6.5% or higher. These patients were described as potential participants by the researchers and experimental (30 patients) and control (30 patients) groups were formed by using simple random numbers table. The participants were explained about the aim of the study and oral and written permissions were taken. During the study period, 6 patients in the experimental group and 3 patients in the control group left the study for various reasons and the study was ended with 51 patients. In data collection, patient information form prepared by the researchers (age, gender, marital status, educational status, disease duration, presence of another chronic disease and smoking status), metabolic variable values (HbA1c and fasting blood sugar) and Summary of diabetes self-care activities scale (SDSCA) developed by Toobert and Glaskow (1994) and revised in 2000 (D.J. Toobert et al., 2000) were used. Summary of diabetes self-care activities scale consists of subscales such as patient diet, exercise, blood sugar test, foot care and smoking. As a result of the calculation of scores, high scores indicate that patients can fulfil self-care behaviors. After the initial data were collected, the patients in the experimental group were given appointments by the researcher for MI intervention. No intervention was performed on the control group participants and they were given appointment for post-test application three months later.
2.1. Intervention In addition to the care they always received, MI sessions were conducted by the researcher for the participants in the experimental group. This intervention was conducted as 30-45 minutes of 12 sessions in total for each patient for a period of 3 months by the academic nurse. In these sessions, the agenda was created in accordance with the nature of MI intervention, efforts were made to resolve the ambivalent feelings in the patient, the patient's change phase was determined, the patient's self-confidence for change was determined, it was questioned how much the patient cared for change and the patient was helped in determining the change plan. In addition, during the sessions, the problems patients experienced about self-care activities, the causes of these problems and the barriers in maintaining self-care activities were discussed and efforts were made to create awareness in patients.
In each MI session;
- Opening and structuring; Meeting, information was given about our role and goals in the study, how much time the investigators have, the role of the counselee and about there will be detailed questions during the study and the session was opened with the question What is on your mind?'
- Creating agenda: What are the investigators going to talk about today? (What would participants like to talk about today, having your blood sugar measured, eating healthily, getting your medication or exercising/Maybe there is something else?)
- Decision balance: Conflict was created in individuals by asking them to compare their existing healthcare behaviors and ideal/desired healthcare behaviors.
- Determining significance and confidence: How important is it for participants to fulfil self-care activities? How much confidence do participants have in yourself about this?
- Change plan: After decision balance was established, its suitability for patients was evaluated, at the end of the session, an action (change) plan was created for the desired behavior change and the session was closed by determining the next interview day-hour.
In the last MI session:
- The session was opened by summarizing the previous interview.
- A general discussion was made on change.
- Individuals' self-care activities were evaluated (The Summary of Diabetes Self-Care)
- Appointment was made from the hospital for individuals to have their glycemic values measured and the values were recorded (glycemic laboratory results).
- Closing.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Motivational Interviewing | Experimental | Behavioral: Motivational İnterviewingIntervention In addition to the care they always received, MI sessions were conducted by the researcher for the participants in the experimental group. This intervention was conducted as 30-45 minutes of 12 sessions in total for each patient for a period of 3 months by the academic nurse. In these sessions, the agenda was created in accordance with the nature of MI intervention, efforts were made to resolve the ambivalent feelings in the patient, the patient's change phase was determined, the patient's self-confidence for change was determined, it was questioned how much the patient cared for change and the patient was helped in determining the change plan. In addition, during the sessions, the problems patients experienced about self-care activities, the causes of these problems and the barriers in maintaining self-care activities were discussed and efforts were made to create awareness in patients. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 18 and older
- Diagnosed with T2DM at least six months ago
- To be literate
- Living in the city centre
- HbA1c value of 6.5% or higher
Key exclusion criteria (1 listed)
- Having any psychiatric disease and mental problems
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 |
|---|---|---|
| Motivational İnterviewingMotivational Interviewing (MI), which is one of these methods, is an individual-based counselling approach that can easily be used by nurses who have been trained to help the management of disease in chronic diseases (Berhe et al., 2020; Kızılırmak \& Demir, 2018; Maslakpak et al., 2020). The core principles of MI includes expressing empathy by providing acceptance and understanding, realizing inconsistencies, avoiding discussions and supporting self-efficacy (Matinolli et al., 2012). The main purpose of MI is to identify the ambivalent emotions that occur in the patient in health-related activities, to strengthen and encourage insights of patients by supporting healthy lifestyle changes and self-confidence (R.Miller \& Rollnick, 2013). Because of its flexibility and ability to be applied in different behavioural aspects, MI can be administered individually and in groups by trained individuals (Maslakpak et al., 2020). | Behavioural | Motivational Interviewing |
Primary outcome
Summary of diabetes self-care activities scale (SDSCA)
Time frame: 3 months after the start of the study
Summary of diabetes self-care activities scale consists of patient diet, exercise, blood sugar test, foot care and smoking.
1 secondary outcome
Metabolic variable values
Time frame: 3 months after the start of the study
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 16 Sep 2022.
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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.
Elanur Uludağ, Dr. principal investigator
Erzurum Technical 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 Motivational İnterviewing in people with Diabetes Mellitus, Type 2, run by Erzurum Technical 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 6 inclusion and 1 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 16 Sep 2022. 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?
Summary of diabetes self-care activities scale (SDSCA) (time frame: 3 months after the start of 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 16 Sep 2022.