Diabetes Mellitus, Type 2NCT05680207
Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings
A study testing Diabetes self- management education (DSME) program in people with Diabetes Mellitus, Type 2 and Empowerment, run by Kutahya Health Sciences University at 1 site in Turkey (Türkiye).
Trial summary
In this study, the effect of nurse-led empowerment training given to patients with Type 2 Diabetes on clinical findings and empowerment behaviors will be investigated. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Empowerment, Patient Empowerment
- What is being tested?
- Diabetes self- management education (DSME) program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 216 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Mar 2019to 30 Aug 2019
- 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
- Patients with Type 2 Diabetes Mellitus diagnosed more than 1 year ago
Who cannot join
- Mental retardation
- Dementia
- Deafness
- Blindness
- Psychiatric illness
- Steroid use
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings: A Randomized Controlled Trial
In this study, the effect of nurse-led empowerment training given to patients with Type 2 Diabetes on clinical findings and empowerment behaviors will be investigated.
Read the detailed description
The research is a randomized controlled design research that includes a pre-test/post-test design. The primary outcome expected in the research; change in empowerment behaviors as a result of the training given; secondary outcomes are changes in clinical findings.
The research universe; All Type 2 diabetes patients who applied to the endocrinology polyclinic of a private hospital in Eskisehir city center between March-July 2019 consisted of. In the study, the sample was randomly selected, and it was aimed to reach all patients with Type 2 diabetes who were 18 years of age and older, with a diagnosis period of one year or more.
In the study, patients were randomly assigned to the intervention group, which included 6 weeks of training, or to the control group, which was on a 6-week waiting list. It used a question-based format to address the educational, behavioral, and psychosocial needs of patients within the scope of a 12-hour empowerment program that lasted for 6 weeks, 2 hours a week.
Education (DSMS (Developing Empowerment-Based Diabetes Self-Management Support)) is planned as stated literature.
Purpose of education: Empowerment as a philosophy of care emphasizes a collaborative approach to facilitating behavior change for patients themselves. Empowerment approach; Goal setting is a five-step process that provides patients with the knowledge and clarity they need to develop and achieve their diabetes and lifestyle goals. The first two steps are to identify the problem and identify patients' beliefs, thoughts, and feelings that may support or hinder their efforts. The third step is to determine the long-term goals expected from patients. In this step, patients are then expected to make a behavioral change that will help them achieve their long-term goals. The last step is for patients to evaluate their efforts and determine what they have learned in the process. Empowerment training was determined within the framework of this process.
- Conditions
- Diabetes Mellitus, Type 2, Empowerment, Patient Empowerment
- Being tested
- Diabetes self- management education (DSME) program
- Medical subject headings
- Diabetes Mellitus, Type 2, Empowerment, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diabetes self- management education (DSME) programBehavioural
We offered a two-hour course each week, comprising of two sessions of lectures (40 minutes each), two breaks (10 min each) and interactive session (20 min). In the interactive session, patients could communicate with each other in groups or raise any questions to the investigators.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Type 2 Diabetes Mellitus patients who received a empowerment training program for 6 weeks, 2 hours a week Receives: Behavioral: Diabetes self- management education (DSME) program |
| Control group | No intervention | Type 2 Diabetes Mellitus patients who did not receive a empowerment training program |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement in The Diabetes Empowerment Scale scores
The Diabetes Empowerment Scale (DES-28) questionnaires consist of 28 items with 3 subscales, with each item rated along a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The range of score was divided in three subgroups as low (28-65 scores), middle (66-103) and high (104-140).
All items have been scored so that a higher value indicates stronger empowerment.
Measured: 3 months
Secondary outcomes (4)
improvement in HbA1c levels
decrease in HbA1c (mmol/mol)
Measured: 6 months
improvement in fasting glucose
decrease in fasting glucose (mmol/L)
Measured: 6 months
improvement in low density lipoprotein
decrease in low density lipoprotein (mmol/L)
Measured: 6 months
improvement in triglyceride
decrease in triglyceride (mmol/L)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2023
- Study start1 Mar 2019
- Primary completion30 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by Kutahya Health Sciences 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 216 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kutahya Health Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muzelfe BIYIK, Kutahya Health Sciences University
- Investigators
- müzelfe bıyık, Ms, Study chair, Eskişehir Osmangazi University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05680207
- Sponsor's protocol ID
- DM Training
- Status last verified
- Jan 2023
- First submitted
- 20 Dec 2022
- Last updated
- 11 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Messina R, Rucci P, Sturt J, Mancini T, Fantini MP. Assessing self-efficacy in type 2 diabetes management: validation of the Italian version of the Diabetes Management Self-Efficacy Scale (IT-DMSES). Health Qual Life Outcomes. 2018 Apr 23;16(1):71. doi: 10.1186/s12955-018-0901-3.
PubMed 29685153
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Empowerment Training on Type 2 Diabetes Patients on Empowerment Levels and Clinical Findings: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05680207
- Acronym / sponsor ID
- DM Training
- Conditions
- Diabetes Mellitus, Type 2, Empowerment, Patient Empowerment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 216 participants (actual)
- Lead sponsor
- Kutahya Health Sciences UniversityUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 11 Jan 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.
In this study, the effect of nurse-led empowerment training given to patients with Type 2 Diabetes on clinical findings and empowerment behaviors will be investigated.
Detailed description
The research is a randomized controlled design research that includes a pre-test/post-test design. The primary outcome expected in the research; change in empowerment behaviors as a result of the training given; secondary outcomes are changes in clinical findings.
The research universe; All Type 2 diabetes patients who applied to the endocrinology polyclinic of a private hospital in Eskisehir city center between March-July 2019 consisted of. In the study, the sample was randomly selected, and it was aimed to reach all patients with Type 2 diabetes who were 18 years of age and older, with a diagnosis period of one year or more.
In the study, patients were randomly assigned to the intervention group, which included 6 weeks of training, or to the control group, which was on a 6-week waiting list. It used a question-based format to address the educational, behavioral, and psychosocial needs of patients within the scope of a 12-hour empowerment program that lasted for 6 weeks, 2 hours a week.
Education (DSMS (Developing Empowerment-Based Diabetes Self-Management Support)) is planned as stated literature.
Purpose of education: Empowerment as a philosophy of care emphasizes a collaborative approach to facilitating behavior change for patients themselves. Empowerment approach; Goal setting is a five-step process that provides patients with the knowledge and clarity they need to develop and achieve their diabetes and lifestyle goals. The first two steps are to identify the problem and identify patients' beliefs, thoughts, and feelings that may support or hinder their efforts. The third step is to determine the long-term goals expected from patients. In this step, patients are then expected to make a behavioral change that will help them achieve their long-term goals. The last step is for patients to evaluate their efforts and determine what they have learned in the process. Empowerment training was determined within the framework of this process.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Behavioral: Diabetes self- management education (DSME) programType 2 Diabetes Mellitus patients who received a empowerment training program for 6 weeks, 2 hours a week |
| Control group | No intervention | –Type 2 Diabetes Mellitus patients who did not receive a empowerment training program |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with Type 2 Diabetes Mellitus diagnosed more than 1 year ago
Key exclusion criteria (6 listed)
- Mental retardation
- Dementia
- Deafness
- Blindness
- Psychiatric illness
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 self- management education (DSME) programWe offered a two-hour course each week, comprising of two sessions of lectures (40 minutes each), two breaks (10 min each) and interactive session (20 min). In the interactive session, patients could communicate with each other in groups or raise any questions to the investigators. | Behavioural | Intervention group |
Primary outcome
improvement in The Diabetes Empowerment Scale scores
Time frame: 3 months
The Diabetes Empowerment Scale (DES-28) questionnaires consist of 28 items with 3 subscales, with each item rated along a 5-point Likert scale (1 = strongly disagree, 2 = disagree, 3 = neutral, 4 = agree, 5 = strongly agree). The range of score was divided in three subgroups as low (28-65 scores), middle (66-103) and high (104-140). All items have been scored so that a higher value indicates stronger empowerment.
4 secondary outcomes
improvement in HbA1c levels
Time frame: 6 months
improvement in fasting glucose
Time frame: 6 months
improvement in low density lipoprotein
Time frame: 6 months
improvement in triglyceride
Time frame: 6 months
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 Jan 2023.
- Results publication: PubMed 29685153Messina R, Rucci P, Sturt J, Mancini T, Fantini MP. Assessing self-efficacy in type 2 diabetes management: validation of the Italian version of the Diabetes Management Self-Efficacy Scale (IT-DMSES). Health Qual Life Outcomes. 2018 Apr 23;16(1):71. doi: 10.1186/s12955-018-0901-3.
- 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.
müzelfe bıyık, Ms study chair
Eskişehir Osmangazi 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 Diabetes self- management education (DSME) program in people with Diabetes Mellitus, Type 2 and Empowerment, run by Kutahya Health Sciences 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 1 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: finished, as of the sponsor's last update on 11 Jan 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?
improvement in The Diabetes Empowerment Scale scores (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05680207, which also lists 1 linked publication.
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 Jan 2023.