Back to resultsEffect of Patient Education on Healthy Lifestyle Behaviors and Diabetes Self-management in Diabetics
Primary Purpose
Diabetes Mellitus, Type 2, Myocardial Infarction
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Planned patient education
Sponsored by
About this trial
This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Diabetes, Patient education, Diabetes self-management, Myocardial infarction, Healthy lifestyle behaviors
Eligibility Criteria
Inclusion Criteria: 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, 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 Exclusion Criteria: Sedative or narcotic analgesic drug treatment, Use of antipsychotic medication Patients receiving Continous Positive Airway Pressure treatment, Patients with cognitive dysfunction
Sites / Locations
- Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Planned patient education
Routine patient education
Arm Description
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".
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".
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT05954819
First Posted
July 6, 2023
Last Updated
October 2, 2023
Sponsor
Istanbul University - Cerrahpasa (IUC)
1. Study Identification
Unique Protocol Identification Number
NCT05954819
Brief Title
Effect of Patient Education on Healthy Lifestyle Behaviors and Diabetes Self-management in Diabetics
Official Title
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Department of Medical Nursing
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
July 28, 2023 (Actual)
Primary Completion Date
August 15, 2023 (Actual)
Study Completion Date
September 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University - Cerrahpasa (IUC)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Myocardial Infarction
Keywords
Diabetes, Patient education, Diabetes self-management, Myocardial infarction, Healthy lifestyle behaviors
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Planned patient education
Arm Type
Experimental
Arm Description
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".
Arm Title
Routine patient education
Arm Type
No Intervention
Arm Description
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".
Intervention Type
Other
Intervention Name(s)
Planned patient education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of Healthy Lifestyle Behaviors
Description
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.
Time Frame
Change from Baseline Healthy Lifestyle Behaviors at 4 Weeks
Title
Change of Diabetes Self-Management
Description
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.
Time Frame
Change from Baseline Diabetes Self-Management at 4 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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,
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
Exclusion Criteria:
Sedative or narcotic analgesic drug treatment,
Use of antipsychotic medication
Patients receiving Continous Positive Airway Pressure treatment,
Patients with cognitive dysfunction
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arzu Erkoc
Organizational Affiliation
Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing
Official's Role
Study Director
Facility Information:
Facility Name
Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing
City
Istanbul
ZIP/Postal Code
34381
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
This study is planned as a master's thesis. Data can be shared after the thesis is completed.
IPD Sharing Time Frame
The data will become available after two years.
IPD Sharing Access Criteria
Criteria is to refer to this study.
Learn more about this trial
Effect of Patient Education on Healthy Lifestyle Behaviors and Diabetes Self-management in Diabetics
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