Diabetes Mellitus, Type 2NCT05954819
Effect of Patient Education on Healthy Lifestyle Behaviors and Diabetes Self-management in Diabetics
A study testing Planned patient education in people with Diabetes Mellitus, Type 2 and Myocardial Infarction, run by Istanbul University - Cerrahpasa at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine the effect of planned education given to individuals with diabetes mellitus who had myocardial infarction on healthy lifestyle behaviors and diabetes self-management. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 2, Myocardial Infarction
- What is being tested?
- Planned patient education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 28 Jul 2023to 15 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older,
- No advanced hearing and vision problems,
- Able to speak and understand Turkish,
- Easy to communicate,
- Literate,
- Agreeing to participate in the research voluntarily,
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- Hospitalized due to myocardial infarction in the last month,
- Have stayed in the intensive care unit for at least 24 hours,
- No chest pain
- Patients who have been diagnosed with Type 2 Diabetes Mellitus for at least one year
Who cannot join
- Sedative or narcotic analgesic drug treatment,
- Use of antipsychotic medication
- Patients receiving Continous Positive Airway Pressure treatment,
- Patients with cognitive dysfunction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing
Istanbul, 34381
About this study
Official title: Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Department of Medical Nursing
The purpose of this study is to determine the effect of planned education given to individuals with diabetes mellitus who had myocardial infarction on healthy lifestyle behaviors and diabetes self-management.
Read the detailed description
Many coronary heart patients have diabetes. For this reason, it is thought that patients need education in order to gain healthy lifestyle behaviors and to provide self-management of diabetes, which is a major risk factor for coronary artery disease. When the literature was examined, no study could be found that focused on diabetes patients with myocardial infarction and emphasized the importance of patient education. It is thought that this study will make an important contribution in terms of patient education to be given to individuals with diabetes mellitus who have had myocardial infarction.
- Conditions
- Diabetes Mellitus, Type 2, Myocardial Infarction
- Being tested
- Planned patient education
- Keywords
- Diabetes, Patient education, Diabetes self-management, Myocardial infarction, Healthy lifestyle behaviors
- Medical subject headings
- Diabetes Mellitus, Type 2, Myocardial Infarction, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Planned patient educationOther
Patients in the experimental group will be given about 30 minutes of patient education. After the training, a Patient Education Booklet containing Myocardial Infarction and Diabetes Education will be presented to the patients. Control group patients will not be given any training other than the hospital routine.
| Study group | Role | What they receive |
|---|---|---|
| Planned patient education | Experimental | Pre-test data will be obtained by using the "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". The participants will be individual education on myocardial infarction and diabetes by researcher. One month later, the posttest data will be obtained using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". Receives: Other: Planned patient education |
| Routine patient education | No intervention | Pre-test data will be obtained by using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". No attempt will be made to participants by the researcher. Participants will undergo discharge training routinely administered by bedside nurses at the hospital. One month later, the posttest data will be obtained using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Healthy Lifestyle Behaviors
The Healthy Lifestyle Behaviors Scale, which consists of 52 items, has a total of 6 sub-dimensions: spiritual development, health responsibility, physical activity, nutrition, spiritual development, interpersonal relations and stress management.The overall score of the scale gives the healthy lifestyle behaviors score.
Measured: Change from Baseline Healthy Lifestyle Behaviors at 4 Weeks
Change of Diabetes Self-Management
The Diabetes Self-Management Scale, which consists of 19 questions in the scale that evaluate self-management in patients with type 2 diabetes. High scores on the scale indicate good self-management, and low scores indicate poor self-management.
Measured: Change from Baseline Diabetes Self-Management at 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start28 Jul 2023
- Primary completion15 Aug 2023
- Study completion15 Sep 2023
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 Istanbul University - CerrahpasaThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul University - Cerrahpasa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Arzu Erkoc, Istanbul University - Cerrahpasa
- Investigators
- Arzu Erkoc, Study director, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954819
- Sponsor's protocol ID
- IstanbulUC 2022/476
- Status last verified
- Oct 2023
- First submitted
- 6 Jul 2023
- Last updated
- 4 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: This study is planned as a master's thesis. Data can be shared after the thesis is completed.
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Department of Medical Nursing
- ClinicalTrials.gov ID
- NCT05954819
- Acronym / sponsor ID
- IstanbulUC 2022/476
- Conditions
- Diabetes Mellitus, Type 2, Myocardial Infarction
- Keywords
- Diabetes, Patient education, Diabetes self-management, Myocardial infarction, Healthy lifestyle behaviors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Istanbul University - CerrahpasaUniversity, hospital or other
- Study start
- 28 Jul 2023 (actual)
- Primary completion
- 15 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 20 Jul 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.
The purpose of this study is to determine the effect of planned education given to individuals with diabetes mellitus who had myocardial infarction on healthy lifestyle behaviors and diabetes self-management.
Detailed description
Many coronary heart patients have diabetes. For this reason, it is thought that patients need education in order to gain healthy lifestyle behaviors and to provide self-management of diabetes, which is a major risk factor for coronary artery disease. When the literature was examined, no study could be found that focused on diabetes patients with myocardial infarction and emphasized the importance of patient education. It is thought that this study will make an important contribution in terms of patient education to be given to individuals with diabetes mellitus who have had myocardial infarction.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Planned patient education | Experimental | Other: Planned patient educationPre-test data will be obtained by using the "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". The participants will be individual education on myocardial infarction and diabetes by researcher. One month later, the posttest data will be obtained using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". |
| Routine patient education | No intervention | –Pre-test data will be obtained by using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". No attempt will be made to participants by the researcher. Participants will undergo discharge training routinely administered by bedside nurses at the hospital. One month later, the posttest data will be obtained using "Healthy Lifestyle Behaviors Scale" and "Diabetes Self-Management Scale". |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 18 years or older,
- No advanced hearing and vision problems,
- Able to speak and understand Turkish,
- Easy to communicate,
- Literate,
Key exclusion criteria (4 listed)
- Sedative or narcotic analgesic drug treatment,
- Use of antipsychotic medication
- Patients receiving Continous Positive Airway Pressure treatment,
- Patients with cognitive dysfunction
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 |
|---|---|---|
| Planned patient educationPatients in the experimental group will be given about 30 minutes of patient education. After the training, a Patient Education Booklet containing Myocardial Infarction and Diabetes Education will be presented to the patients. Control group patients will not be given any training other than the hospital routine. | Other | Planned patient education |
Primary outcome
Change of Healthy Lifestyle Behaviors
Time frame: Change from Baseline Healthy Lifestyle Behaviors at 4 Weeks
The Healthy Lifestyle Behaviors Scale, which consists of 52 items, has a total of 6 sub-dimensions: spiritual development, health responsibility, physical activity, nutrition, spiritual development, interpersonal relations and stress management.The overall score of the scale gives the healthy lifestyle behaviors score.
Change of Diabetes Self-Management
Time frame: Change from Baseline Diabetes Self-Management at 4 Weeks
The Diabetes Self-Management Scale, which consists of 19 questions in the scale that evaluate self-management in patients with type 2 diabetes. High scores on the scale indicate good self-management, and low scores indicate poor self-management.
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 4 Oct 2023.
- Individual participant dataSharing planned: Yes. This study is planned as a master's thesis. Data can be shared after the thesis is completed.
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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.
Arzu Erkoc study director
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Planned patient education in people with Diabetes Mellitus, Type 2 and Myocardial Infarction, run by Istanbul University - Cerrahpasa 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 10 inclusion and 4 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 4 Oct 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?
Change of Healthy Lifestyle Behaviors (time frame: Change from Baseline Healthy Lifestyle Behaviors at 4 Weeks). The study lists 2 primary outcomes in all. 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 4 Oct 2023.