Effect of Patient Education on Healthy Lifestyle Behaviors and Diabetes Self-management in Diabetics

Sponsor

Istanbul University - Cerrahpasa (IUC) (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05954819

Collaborator

(none)

102

Enrollment

Location

Arms

3.6

Anticipated Duration (Months)

28.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus, Type 2 Myocardial Infarction	Other: Planned patient education	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

102 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

Official Title:

Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing, Department of Medical Nursing

Anticipated Study Start Date :

Jul 28, 2023

Anticipated Primary Completion Date :

Aug 15, 2023

Anticipated Study Completion Date :

Nov 15, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Planned patient education 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".	Other: Planned patient education 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.
No Intervention: Routine patient education 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".

Arm

Intervention/Treatment

Experimental: Planned patient education

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".

Other: Planned patient education

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.

No Intervention: Routine patient education

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".

Outcome Measures

Primary Outcome Measures

Change of Healthy Lifestyle Behaviors [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul University-Cerrahpasa Florence Nightingale Faculty of Nursing	Istanbul		Turkey	34381

Sponsors and Collaborators

Istanbul University - Cerrahpasa (IUC)

Investigators

Study Director: Arzu Erkoc, Istanbul University-Cerrahpasa, Florence Nightingale Faculty of Nursing

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Arzu Erkoc, Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing, Department of Medical Nursing, Istanbul University - Cerrahpasa (IUC)

ClinicalTrials.gov Identifier:

NCT05954819

Other Study ID Numbers:

IstanbulUC 2022/476

First Posted:

Jul 20, 2023

Last Update Posted:

Jul 28, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Arzu Erkoc, Istanbul University - Cerrahpasa, Florence Nightingale Faculty of Nursing, Department of Medical Nursing, Istanbul University - Cerrahpasa (IUC)

Diabetes

Patient education

Diabetes self-management

Myocardial infarction

Healthy lifestyle behaviors

Additional relevant MeSH terms:

Myocardial Infarction

Diabetes Mellitus

Diabetes Mellitus, Type 2

Infarction

Study Results

No Results Posted as of Jul 28, 2023