NCT07701109

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
12mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 1, 2026

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 14, 2026

Completed
18 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Expected
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2027

6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2027

Last Updated

July 14, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

July 1, 2026

Last Update Submit

July 13, 2026

Conditions

Keywords

Myocardial InfarctionLACE IndexIndividualized Discharge EducationHospital Readmission

Outcome Measures

Primary Outcomes (5)

  • 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.

    Day 1

  • 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.

    Day 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.

    Day 1

  • 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.

    Day 1

  • 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.

    Day 1

Secondary Outcomes (2)

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

    Day 1, first month and third month

  • Heart Quality of Life (HeartQoL) Scale: The Heart Quality of Life (HeartQoL) Scale

    Day 1, first month and third month

Study Arms (2)

Individualized discharge education group

EXPERIMENTAL

Experimental arm

Behavioral: Individualized discharge education

Control group

NO INTERVENTION

Control arm

Interventions

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.

Individualized discharge education group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Adıyaman University

Adıyaman, Besni, 02100, Turkey (Türkiye)

Location

Related Publications (10)

  • 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.

    PMID: 22822180BACKGROUND
  • 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.

    PMID: 27686630BACKGROUND
  • 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.

    PMID: 32369875BACKGROUND
  • 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.

    PMID: 33489636BACKGROUND
  • 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.

    PMID: 37084014BACKGROUND
  • 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.

    PMID: 27595679BACKGROUND
  • 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

    BACKGROUND
  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Reva G GÜNDOĞAN, Asst. Prof.

    Adiyaman University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reva G GÜNDOĞAN, Asst. Prof.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

July 1, 2026

First Posted

July 14, 2026

Study Start (Estimated)

August 1, 2026

Primary Completion (Estimated)

January 31, 2027

Study Completion (Estimated)

August 1, 2027

Last Updated

July 14, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Data can be shared with researchers upon request.

Locations