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Patients With Acute Myocardial Infarction

Primary Purpose

Cardiovascular Diseases

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
discharge training
Sponsored by
Celal Bayar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cardiovascular Diseases focused on measuring discharge training, acute myocardial infarction, compliance to drug, compliance to diet, CARRF-KL.

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Acute myocardial infarction
  • Discharge planned
  • Minimal literacy
  • 18-75 years of age
  • No cancer or psychiatric diagnosis
  • Not previously trained
  • Being willing to participate in research

Exclusion Criteria:

  • Patients who had myocardial infarction,
  • İntubated, who had been intubated,
  • were treated in other services due to additional diseases such as GIS bleeding, pneumonia, etc. after myocardial infarction,
  • patients who had myocardial infarction and returned to their own services after treatment,
  • who wanted to be transferred to another hospital while they were receiving treatment after myocardial infarction,
  • who wanted to go to another hospital for an outpatient appointment,
  • who did not want to come to polyclinic control from another city caused data loss.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental group (EG)

    Control group

    Arm Description

    At the first interview, after the application of the scales to the intervention group patients, planned discharge training and the manual prepared by the researcher were given. The second interview was performed 4 weeks later and the same scales were reapplied.

    In the first interview, scales were applied to the control group patients but planned discharge training was not given. The second interview was carried out 4 weeks later, and after the same scales were reapplied to the control group patients, planned discharge training was given. Therefore, the right of individuals to get education was not prevented.

    Outcomes

    Primary Outcome Measures

    Beliefs about Medication Compliance Scale
    There are 12 sub-dimensions of the scale, namely benefit and disability; Items 1, 2, 7, 10, 11 measure the person's perception of benefit and items 3, 4, 5, 6, 8, 9, 12 measure the perception of obstacles. A higher score in the benefit subscale indicates that the perceived benefit is greater with behavior. The high score on the obstacles subscale shows that the subject perceives more of the obstacles when performing a behavior. The minimum total score of the scale is 12 and the maximum total score is 60.
    Beliefs about Dietary Compliance Scale
    It is a five-point Likert-type scale and consists of 12 items. There are two sub-dimensions: utility and obstacle. The first sub-dimension measures the individual's perception of benefit (items 1-5, 11, 12), and the second sub-dimension measures the perception of obstacles (items 6-10). The minimum total score of the scale is 12 and the maximum total score is 60.
    Beliefs about Self-Monitoring Scale
    Beliefs about Individual Follow-up Scale is a five-point Likert-type scale consisting of 18 items. There are two sub-dimensions: utility and obstacle. The benefits subscale (items 3, 5, 11, 15-17) showed that benefits were perceived more with higher scores; The high score in the obstacle subscale (items 1, 2, 4, 6-10, 12-14, 18) shows that the subject perceives more obstacles in conducting a behavior. The minimum total score of the scale is 18 and the maximum total score is 90.
    Cardiovascular Disease Risk Factors Knowledge Level Scale.
    The scale consists of 28 items. The first four of these items are the characteristics of cardiovascular diseases, 15 items are risk factors (5, 6, 9-12, 14, 18-20, 23-25, 27, 28 items), nine items (7, 8, 13, 15, 16, 17, 21, 22, 26) question the outcome of changes in risk behavior. The items in the scale are given as a complete sentence which can be true or false and they are asked to answer "Yes", "No" or iy I do not know ". Each correct answer is given 1 point. Twenty-two questions are scored straight and six questions (11, 12, 16, 17, 24, 26) are scored in the opposite direction. The highest total score that can be obtained from the scale is 28.

    Secondary Outcome Measures

    Full Information

    First Posted
    May 27, 2019
    Last Updated
    June 12, 2019
    Sponsor
    Celal Bayar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03985397
    Brief Title
    Patients With Acute Myocardial Infarction
    Official Title
    Evaluation of the Effect of Planned Discharge Training on Health Knowledge and Beliefs on Patients With Acute Myocardial Infarction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    September 1, 2016 (Actual)
    Primary Completion Date
    December 1, 2017 (Actual)
    Study Completion Date
    December 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Celal Bayar University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aims and objectives The aim of this study was to determine whether planned discharge training given by the nurse has an impact on beliefs about cardiovascular disease risk factors knowledge level, compliance to drug therapy, compliance to diet and self- monitoring in patients with acute myocardial infarction (AMI). Background: Increasing frequency of AMI, discharge of patients without discharge training cause recurrence of the disease and death. Design: This study was done experimentally randomized controlled. Methods: The sample of the study includes 100 patients who were hospitalized due to AMI between September 2016 and December 2017 in coronary intensive care unit and cardiology department. The patients were divided into two groups according to random sampling method: intervention (n = 50) and control (n = 50) groups. Planned discharge training was given to the intervention group. Two interviews were conducted with each group with a one month break. The data of the research were collected by using the Patient Information Form, Beliefs about Medication Compliance Scale (BMCS), Beliefs about Dietary Compliance Scale (BDCS) and Beliefs about Self-Monitoring Scale (BSMS) and Cardiovascular Disease Risk Factors Knowledge Level (CARRF-KL) Scale.
    Detailed Description
    Cardiovascular diseases are one of the leading causes of mortality in all populations nowadays. Coronary artery disease (CAD) is considered to be the first cause of all deaths in the world. In 2017, 31% of the worldwide deaths (17.7 million) were caused by cardiovascular diseases. 80% of cardiovascular diseases are related to myocardial infarction (MI). It is thought that deaths due to cardiovascular diseases will reach 23.6 million in 2030. Myocardial infarction is an irreversible heart muscle necrosis caused by prolonged ischemia. There are many factors that are effective in the formation of acute myocardial infarction (AMI). It is significant to know these factors that pose a risk to protection from this disease. Some of the risk factors can be changed and others include factors that are not possible to change. Risk factors that cannot be changed include individual features which are impossible to change; gender, age, family history, and presence of ACS in the history, biochemical or physiological features. In addition, risk factors that can be changed include obesity, low HDL-cholesterol level, high blood pressure, thrombogenic factors, hyperglycemia/diabetes mellitus, high plasma cholesterol, high plasma triglyceride level, stress, cholesterol-rich and high-calorie eating habits, smoking, consuming excess alcohol and sedentary life. In patients with myocardial infarction, the mortality rate was 10% in the first years and 5% in the following years. Nurses play a significant role in the development, maintenance and prevention of diseases. Individuals with cardiovascular diseases should be given appropriate training before being discharged from the hospital. Training plan in patient/family education should be planned according to individual's readiness to learn, learning needs, education levels and previous experiences. In the context of an effective training: in addition to basic information such as giving necessary information about the disease, cardiovascular risk factors and ways to reduce them, the importance of life change (drug use, healthy nourishment, smoking cessation, physical activity, etc.), regular policlinic control and guidance to cardiac rehabilitation program; information to meet the basic needs of the individual (return to work after MI, sexual life, housework, travel, driving, etc.) should be included. It is stated that the healing processes of the patients who are given discharge training have accelerated, and the number of recurrent applications to the hospital/policlinic has decreased and accordingly the patient care costs have decreased and the quality of care has increased.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases
    Keywords
    discharge training, acute myocardial infarction, compliance to drug, compliance to diet, CARRF-KL.

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    The patients were randomly assigned to the intervention (50 patients) and control groups (50 patients) by lot according to the protocol numbers that are even and odd numbers (even numbers; the intervention group, odd numbers; the control group).
    Masking
    Investigator
    Allocation
    Randomized
    Enrollment
    100 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental group (EG)
    Arm Type
    Experimental
    Arm Description
    At the first interview, after the application of the scales to the intervention group patients, planned discharge training and the manual prepared by the researcher were given. The second interview was performed 4 weeks later and the same scales were reapplied.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    In the first interview, scales were applied to the control group patients but planned discharge training was not given. The second interview was carried out 4 weeks later, and after the same scales were reapplied to the control group patients, planned discharge training was given. Therefore, the right of individuals to get education was not prevented.
    Intervention Type
    Other
    Intervention Name(s)
    discharge training
    Intervention Description
    Providing planned discharge training according to the level of knowledge about diet, drug and individual monitoring compliance and cardiovascular risk factors of patients with acute myocardial infarction
    Primary Outcome Measure Information:
    Title
    Beliefs about Medication Compliance Scale
    Description
    There are 12 sub-dimensions of the scale, namely benefit and disability; Items 1, 2, 7, 10, 11 measure the person's perception of benefit and items 3, 4, 5, 6, 8, 9, 12 measure the perception of obstacles. A higher score in the benefit subscale indicates that the perceived benefit is greater with behavior. The high score on the obstacles subscale shows that the subject perceives more of the obstacles when performing a behavior. The minimum total score of the scale is 12 and the maximum total score is 60.
    Time Frame
    5-10 minutes
    Title
    Beliefs about Dietary Compliance Scale
    Description
    It is a five-point Likert-type scale and consists of 12 items. There are two sub-dimensions: utility and obstacle. The first sub-dimension measures the individual's perception of benefit (items 1-5, 11, 12), and the second sub-dimension measures the perception of obstacles (items 6-10). The minimum total score of the scale is 12 and the maximum total score is 60.
    Time Frame
    5-10 minutes
    Title
    Beliefs about Self-Monitoring Scale
    Description
    Beliefs about Individual Follow-up Scale is a five-point Likert-type scale consisting of 18 items. There are two sub-dimensions: utility and obstacle. The benefits subscale (items 3, 5, 11, 15-17) showed that benefits were perceived more with higher scores; The high score in the obstacle subscale (items 1, 2, 4, 6-10, 12-14, 18) shows that the subject perceives more obstacles in conducting a behavior. The minimum total score of the scale is 18 and the maximum total score is 90.
    Time Frame
    5-10 minutes
    Title
    Cardiovascular Disease Risk Factors Knowledge Level Scale.
    Description
    The scale consists of 28 items. The first four of these items are the characteristics of cardiovascular diseases, 15 items are risk factors (5, 6, 9-12, 14, 18-20, 23-25, 27, 28 items), nine items (7, 8, 13, 15, 16, 17, 21, 22, 26) question the outcome of changes in risk behavior. The items in the scale are given as a complete sentence which can be true or false and they are asked to answer "Yes", "No" or iy I do not know ". Each correct answer is given 1 point. Twenty-two questions are scored straight and six questions (11, 12, 16, 17, 24, 26) are scored in the opposite direction. The highest total score that can be obtained from the scale is 28.
    Time Frame
    5-10 minutes

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    75 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Acute myocardial infarction Discharge planned Minimal literacy 18-75 years of age No cancer or psychiatric diagnosis Not previously trained Being willing to participate in research Exclusion Criteria: Patients who had myocardial infarction, İntubated, who had been intubated, were treated in other services due to additional diseases such as GIS bleeding, pneumonia, etc. after myocardial infarction, patients who had myocardial infarction and returned to their own services after treatment, who wanted to be transferred to another hospital while they were receiving treatment after myocardial infarction, who wanted to go to another hospital for an outpatient appointment, who did not want to come to polyclinic control from another city caused data loss.

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    I do not have a plan

    Learn more about this trial

    Patients With Acute Myocardial Infarction

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