- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07701109
Individualized Discharge Education in High-Risk Myocardial Infarction Patients (MI)
The Effect of Individualized Discharge Education on Readmission Rates in a High-Risk Population According to the LACE Index After Myocardial Infarction
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Reva G GÜNDOĞAN, Asst. Prof.
- Phone Number: +905551822097
- Email: r4a5reva@gmail.com
Study Locations
-
-
Besni
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Adıyaman, Besni, Turkey (Türkiye), 02100
- Adıyaman University
-
Contact:
- Reva GÜNDOĞAN, Asst. Prof.
- Phone Number: 05551822097
- Email: r4a5reva@gmail.com
-
Contact:
- Sevim Güler, Nurse PhD
- Phone Number: +905055894983
- Email: sdegerguler@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Being over 18 years of age,
- Not having a cognitive disorder,
- Not having a history of psychiatric disorders,
- Being open to communication,
- Not having hearing, visual or speech impairments,
- Having a LACE index score of 10 or higher,
- Being willing to participate in the research.
Exclusion Criteria:
- Refusal to participate in the study
- Having a LACE index score below 10
- Not having a cognitive impairment,
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Individualized discharge education group
Experimental arm
|
Education will cover the following topics: Disease Knowledge and Process Management: Definition of myocardial infarction, long-term management of the disease, risk of recurrence, and recognition of complication symptoms. Adherence to Medication Therapy: Regular use of medications, their effects, and methods of administration. Management of Comorbidities: Monitoring and managing existing co-occurring conditions as part of the overall care plan. Self-Care and Lifestyle Modifications: Nutrition: Adopting low-fat dietary habits that support heart health. Physical Activity: The importance of regular exercise and a safe activity plan. Risk Factor Control: Smoking cessation and avoiding smoke-filled environments, weight control, and blood pressure monitoring. Symptom Management: Recognizing potential symptoms and the necessary actions to take in such situations . Psychosocial Support: Strategies for managing disease-related stress and improving quality of life. |
|
No Intervention: Control group
Control arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
LACE index
Time Frame: Day 1
|
LACE (Length of stay, Acuity of admission, Comorbidity, Emergency department visits) Index: The LACE index was first developed by van Walraven et al. to estimate the risk of unplanned readmission or death within 30 days of hospital discharge in medical and surgical patients.
The model was derived and validated based on administrative data with a C-statistic of 0.68.
The model includes length of hospital stay (L), severity of admission (A), comorbidities of patients (C), and the number of emergency department visits within six months prior to admission (E).
Scores ranging from "0" to "19" and greater than ten are considered a high risk for 30-day readmission.
Higher scores indicate a high risk of readmission.
This tool is widely used primarily due to its simplicity and usability in daily clinical practice.
|
Day 1
|
|
Percutaneous Coronary Intervention Information Needs Scale (NCPI-10)
Time Frame: Day 1
|
Percutaneous Coronary Intervention Information Needs Scale (NCPI-10): This scale is a 10-item scale that assesses the information needs of patients undergoing percutaneous coronary intervention (PCI) .
The Turkish validity and reliability study was conducted by Tüllüce et al. in 2025.
A four-point Likert scale was used to answer all items in the scale.
The total score of each result is between 10-40.
As the importance level score of the information need increases, the importance level for the patient increases.
As the level of fulfillment of the information need score increases, the level of fulfillment of the needs increases.
The Cronbach alpha internal consistency coefficient of the scales was found to be 0.98 for the importance level of the information need and 0.98 for the degree of fulfillment.
|
Day 1
|
|
The Self-Care of Coronary Heart Disease Inventory (SC-CHDI)
Time Frame: Day 1
|
The Self-Care of Coronary Heart Disease Inventory (SC-CHDI) was developed by Dickson et al. to assess the self-care levels of individuals with coronary heart disease.
Its Turkish validity and reliability study was conducted by Bayrak and Oğuz (2020).
The scale consists of 22 items and three sub-dimensions: maintaining self-care (10 items), managing self-care (6 items), and self-care confidence (6 items).
Items are generally scored on a Likert scale from 1=never, 2=sometimes, 3=frequently, and 4=always, with some items in the self-care management sub-dimension being rated between 0 and 4. A total score is not obtained from the scale; each sub-dimension is evaluated separately, and higher scores indicate a better level of self-care.
In the Turkish adaptation study, the Cronbach's alpha coefficients of the scale were found to be 0.63 for maintaining self-care, 0.76 for managing self-care, and 0.95 for self-care confidence.
|
Day 1
|
|
Heart Quality of Life (HeartQoL) Scale
Time Frame: Day 1
|
Heart Quality of Life (HeartQoL) Scale: The Heart Quality of Life (HeartQoL) Scale was developed to measure quality of life in individuals with ischemic heart disease .
A Turkish validity and reliability study was conducted by Duğan & Bektaş in 2020.
The original scale included patients with angina pectoris, myocardial infarction, and ischemic heart failure within ischemic heart disease.
The scale consists of 14 items, divided into two sub-dimensions: physical (10 items; 1, 2, 3, 4, 5, 6, 7, 8, 13, 14) and emotional characteristics (4 items; 9, 10, 11, 12).
Each item in the HeartQoL Scale is scored between 0 and 3; 3 represents "no discomfort" and 0 represents "very discomfort".
In the evaluation of the scale, high scores indicate the absence of dysfunction.
The Cronbach's alpha reliability coefficient was found to be 0.88 overall, and between 0.74 and 0.87 in its sub-dimensions.
|
Day 1
|
|
Personal Information Form
Time Frame: Day 1
|
Personal Information Form: Prepared by researchers through a literature review, this form will include 22 questions covering socioeconomic and disease information, as well as systolic blood pressure, diastolic blood pressure, fasting blood glucose, total cholesterol, triglycerides, HDL, LDL, and BMI values.
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The Self-Care of Coronary Heart Disease Inventory (SC-CHDI)
Time Frame: Day 1, first month and third month
|
The Self-Care of Coronary Heart Disease Inventory (SC-CHDI) was developed by Dickson et al. to assess the self-care levels of individuals with coronary heart disease.
Its Turkish validity and reliability study was conducted by Bayrak and Oğuz (2020) .
The scale consists of 22 items and three sub-dimensions: maintaining self-care (10 items), managing self-care (6 items), and self-care confidence (6 items).
Items are generally scored on a Likert scale from 1=never, 2=sometimes, 3=frequently, and 4=always, with some items in the self-care management sub-dimension being rated between 0 and 4. A total score is not obtained from the scale; each sub-dimension is evaluated separately, and higher scores indicate a better level of self-care.
In the Turkish adaptation study, the Cronbach's alpha coefficients of the scale were found to be 0.63 for maintaining self-care, 0.76 for managing self-care, and 0.95 for self-care confidence.
|
Day 1, first month and third month
|
|
Heart Quality of Life (HeartQoL) Scale: The Heart Quality of Life (HeartQoL) Scale
Time Frame: Day 1, first month and third month
|
Heart Quality of Life (HeartQoL) Scale: The Heart Quality of Life (HeartQoL) Scale was developed to measure quality of life in individuals with ischemic heart disease .
A Turkish validity and reliability study was conducted by Duğan & Bektaş in 2020.
The original scale included patients with angina pectoris, myocardial infarction, and ischemic heart failure within ischemic heart disease.
The scale consists of 14 items, divided into two sub-dimensions: physical (10 items; 1, 2, 3, 4, 5, 6, 7, 8, 13, 14) and emotional characteristics (4 items; 9, 10, 11, 12).
Each item in the HeartQoL Scale is scored between 0 and 3; 3 represents "no discomfort" and 0 represents "very discomfort".
In the evaluation of the scale, high scores indicate the absence of dysfunction.
The Cronbach's alpha reliability coefficient was found to be 0.88 overall, and between 0.74 and 0.87 in its sub-dimensions .
|
Day 1, first month and third month
|
Collaborators and Investigators
Investigators
- Principal Investigator: Reva G GÜNDOĞAN, Asst. Prof., Adiyaman University
Publications and helpful links
General Publications
- Zhang P, Hu YD, Xing FM, Li CZ, Lan WF, Zhang XL. Effects of a nurse-led transitional care program on clinical outcomes, health-related knowledge, physical and mental health status among Chinese patients with coronary artery disease: A randomized controlled trial. Int J Nurs Stud. 2017 Sep;74:34-43. doi: 10.1016/j.ijnurstu.2017.04.004. Epub 2017 Apr 14.
- Vaughan Dickson V, Lee CS, Yehle KS, Mola A, Faulkner KM, Riegel B. Psychometric Testing of the Self-Care of Coronary Heart Disease Inventory (SC-CHDI). Res Nurs Health. 2017 Feb;40(1):15-22. doi: 10.1002/nur.21755. Epub 2016 Sep 30.
- Lizcano-Alvarez A, Carretero-Julian L, Talavera-Saez A, Cristobal-Zarate B, Cid-Exposito MG, Alameda-Cuesta A; REccAP Group (Red de Enfermeria de Cuidados Cardiovasculares en Atencion Primaria). Intensive nurse-led follow-up in primary care to improve self-management and compliance behaviour after myocardial infarction. Nurs Open. 2023 Aug;10(8):5211-5224. doi: 10.1002/nop2.1758. Epub 2023 Apr 21.
- Oldridge N, Hofer S, McGee H, Conroy R, Doyle F, Saner H; (for the HeartQoL Project Investigators). The HeartQoL: part II. Validation of a new core health-related quality of life questionnaire for patients with ischemic heart disease. Eur J Prev Cardiol. 2014 Jan;21(1):98-106. doi: 10.1177/2047487312450545. Epub 2012 Jul 20.
- Bayrak B, Oguz S. Validity and reliability of the Turkish version of the Self-Care of Coronary Heart Disease Inventory. Int J Nurs Pract. 2021 Feb;27(1):e12847. doi: 10.1111/ijn.12847. Epub 2020 May 5.
- Tsoulou V, Vasilopoulos G, Kapadohos T, Panoutsopoulos G, Kalogianni A, Toulia G, Koutelekos I, Gerogianni G, Polikandrioti M. Information Needs in Percutaneous Coronary Artery Intervention: Validation and Reliability Analysis of NPCI-10 Item Scale. Cureus. 2021 Jan 15;13(1):e12718. doi: 10.7759/cureus.12718.
- Yazdan-Ashoori P, Lee SF, Ibrahim Q, Van Spall HG. Utility of the LACE index at the bedside in predicting 30-day readmission or death in patients hospitalized with heart failure. Am Heart J. 2016 Sep;179:51-8. doi: 10.1016/j.ahj.2016.06.007. Epub 2016 Jun 18.
- Duğan, Ö., & Bektaş, H. (2020). Koroner arter hastalarında Kalp Yaşam Kalitesi Ölçeği'nin Türkçeye uyarlama çalışması. Turkish Journal of Cardiovascular Nursing, 11(25), 71-81. https://doi.org/10.5543/khd.2020.38278
- Rajaguru V, Han W, Kim TH, Shin J, Lee SG. LACE Index to Predict the High Risk of 30-Day Readmission: A Systematic Review and Meta-Analysis. J Pers Med. 2022 Mar 30;12(4):545. doi: 10.3390/jpm12040545.
- Robinson R, Bhattarai M, Hudali T, Vogler C. Predictors of 30-day hospital readmission: The direct comparison of number of discharge medications to the HOSPITAL score and LACE index. Future Healthc J. 2019 Oct;6(3):209-214. doi: 10.7861/fhj.2018-0039.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2026/4-21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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