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Myocardial InfarctionMINCT07701109

Individualized Discharge Education in High-Risk Myocardial Infarction Patients

A study testing Individualized discharge education in people with Myocardial Infarction, run by Adiyaman Provincial Health Directorate at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The purpose of this clinical study is to evaluate whether individualized discharge education is effective in treating patients identified as high-risk based on the LACE index after a myocardial infarction. Additionally, information will be gathered regarding the safety and outcomes of this education. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Myocardial Infarction
What is being tested?
Individualized discharge education
Could I receive a placebo?
No, everyone receives an active treatment
How many people
82 participants
Where
1 siteTurkey (Türkiye)
Study dates
1 Aug 2026to 1 Aug 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • 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.

Who cannot join

  • Refusal to participate in the study
  • Having a LACE index score below 10
  • Not having a cognitive impairment,

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Reva G GÜNDOĞAN, Asst. Prof. contact

+905551822097

r4a5reva@gmail.com

Turkey (Türkiye)1 site

  • Adıyaman University

    Adıyaman, Besni, 02100

    Reva GÜNDOĞAN, Asst. Prof., 05551822097, r4a5reva@gmail.com

    Sevim Güler, Nurse PhD, +905055894983, sdegerguler@gmail.com

Other trials in Turkey (Türkiye)

About this study

Official title: The Effect of Individualized Discharge Education on Readmission Rates in a High-Risk Population According to the LACE Index After Myocardial Infarction

The purpose of this clinical study is to evaluate whether individualized discharge education is effective in treating patients identified as high-risk based on the LACE index after a myocardial infarction. Additionally, information will be gathered regarding the safety and outcomes of this education. The key questions the study aims to answer are: Does individualized discharge education reduce hospital readmission rates for patients identified as high-risk after a myocardial infarction? Does this education improve patients' treatment adherence, self-care levels, and quality of life? Researchers will compare the effectiveness of individualized discharge education against routine care. Participants will:Receive individualized discharge education prior to discharge if they meet the high-risk criteria, and receive a comprehensive educational brochure. Be followed up via telephone three days a week while at home to monitor their care practices and hospital visits. Participate in follow-up assessments at the 1st month (Follow-up 1) and 3rd month (Follow-up 3) to complete the Coronary Heart Disease Self-Care Inventory and the HeartQoL scale.

Read the detailed description

This study is a controlled research project examining the impact of individualized discharge education on clinical outcomes in patients identified as "high-risk" following a myocardial infarction (MI) using the LACE index. The study aims to determine the role of patient education and follow-up during the post-cardiovascular event care process in reducing hospital readmission rates. The fundamental interventions and processes to be carried out within the scope of the research are as follows:Risk Classification: Prior to discharge, patients treated in the cardiology clinic will be assessed using the LACE index, which includes length of hospital stay, acuity of admission, comorbidities, and emergency department visits within the previous 6 months. Patients with a LACE score of 10 or higher will be classified as "high-risk" and included in the study. Educational Intervention: The intervention group will receive a structured discharge education program tailored to the patients' clinical characteristics, educational levels, and risk profiles. During the education process, a comprehensive brochure containing all relevant information will be provided. The control group will continue to receive the hospital's standard routine care. Monitoring and Follow-up: Patients will be followed for 3 months during the post-discharge period. Patients in the intervention group will be contacted by telephone 3 days a week while at home to monitor their self-care practices and hospital visits. Assessment Points: Research data will be collected before discharge (Follow-up 0), at the 1st month post-discharge (Follow-up 1), and at the 3rd month (Follow-up 3). During this process, patients' readmission statuses will be recorded, and clinical changes will be compared using the Percutaneous Coronary Intervention Information Needs Scale (NCPI-10), the Self-Care of Coronary Heart Disease Inventory (SC-CHDI), and the HeartQoL scale. Data Analysis: The collected data will be subjected to statistical analysis using SPSS 29 software to evidence-based demonstrate the effectiveness of individualized nursing education in improving patient outcomes.

Being tested
Individualized discharge education
Keywords
Myocardial Infarction, LACE Index, Individualized Discharge Education, Hospital Readmission
Medical subject headings
Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Individualized discharge educationBehavioural

    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.

Study groups in NCT07701109
Study groupRoleWhat they receive
Individualized discharge education groupExperimentalExperimental arm
Receives: Behavioral: Individualized discharge education
Control groupNo interventionControl arm

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LACE index

    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.

    Measured: Day 1

  2. Percutaneous Coronary Intervention Information Needs Scale (NCPI-10)

    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.

    Measured: Day 1

  3. The Self-Care of Coronary Heart Disease Inventory (SC-CHDI)

    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.

    Measured: Day 1

  4. Heart Quality of Life (HeartQoL) Scale

    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.

    Measured: Day 1

  5. Personal Information Form

    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.

    Measured: Day 1

Secondary outcomes (2)

  1. The Self-Care of Coronary Heart Disease Inventory (SC-CHDI)

    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.

    Measured: Day 1, first month and third month

  2. Heart Quality of Life (HeartQoL) Scale: The Heart Quality of Life (HeartQoL) Scale

    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 .

    Measured: Day 1, first month and third month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start1 Aug 2026 (estimated)
  3. Primary completion31 Jan 2027 (estimated)
  4. Study completion1 Aug 2027 (estimated)

Resources

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
Double blind
Who is masked
Participant, Care provider
Enrolment
82 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07701109
Sponsor's protocol ID
2026/4-21
Acronym
MI
Status last verified
Jul 2026
First submitted
1 Jul 2026
Last updated
14 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Data can be shared with researchers upon request.

Publications

  • 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.

    PubMed 22822180

  • 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.

    PubMed 27686630

  • 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.

    PubMed 32369875

  • 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.

    PubMed 33489636

  • 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.

    PubMed 37084014

  • 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.

    PubMed 27595679

  • 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.

    PubMed 35455661

  • 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.

    PubMed 28601691

  • 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.

    PubMed 31660528

Questions about this trial

What is this clinical trial studying?

A study testing Individualized discharge education in people with Myocardial Infarction, run by Adiyaman Provincial Health Directorate 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 7 inclusion and 3 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: opening soon, as of the sponsor's last update on 14 Jul 2026. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Reva G GÜNDOĞAN, Asst. Prof. (+905551822097, r4a5reva@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LACE index (time frame: Day 1). The study lists 5 primary outcomes in all. 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 NCT07701109, which also lists 10 linked publications.

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 14 Jul 2026.

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