Individualized Discharge Education in High-Risk Myocardial Infarction Patients (MI)
13 juillet 2026 mis à jour par: Reva Gündoğan, Adiyaman Provincial Health Directorate
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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
82
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Reva G GÜNDOĞAN, Asst. Prof.
- Numéro de téléphone: +905551822097
- E-mail: r4a5reva@gmail.com
Lieux d'étude
-
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Besni
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Adıyaman, Besni, Turquie (Türkiye), 02100
- Adıyaman University
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Contact:
- Reva GÜNDOĞAN, Asst. Prof.
- Numéro de téléphone: 05551822097
- E-mail: r4a5reva@gmail.com
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Contact:
- Sevim Güler, Nurse PhD
- Numéro de téléphone: +905055894983
- E-mail: sdegerguler@gmail.com
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La 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,
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Individualized discharge education group
Experimental arm
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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. |
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Aucune intervention: Control group
Control arm
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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LACE index
Délai: Day 1
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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.
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Day 1
|
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Percutaneous Coronary Intervention Information Needs Scale (NCPI-10)
Délai: 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.
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Day 1
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The Self-Care of Coronary Heart Disease Inventory (SC-CHDI)
Délai: 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.
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Day 1
|
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Heart Quality of Life (HeartQoL) Scale
Délai: 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
|
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Personal Information Form
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The Self-Care of Coronary Heart Disease Inventory (SC-CHDI)
Délai: 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
|
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Heart Quality of Life (HeartQoL) Scale: The Heart Quality of Life (HeartQoL) Scale
Délai: 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
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Reva G GÜNDOĞAN, Asst. Prof., Adiyaman University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- 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.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
1 août 2026
Achèvement primaire (Estimé)
31 janvier 2027
Achèvement de l'étude (Estimé)
1 août 2027
Dates d'inscription aux études
Première soumission
1 juillet 2026
Première soumission répondant aux critères de contrôle qualité
13 juillet 2026
Première publication (Réel)
14 juillet 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
14 juillet 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
13 juillet 2026
Dernière vérification
1 juillet 2026
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026/4-21
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime IPD
Data can be shared with researchers upon request.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .