Cardiovascular DiseasesNCT03985397
Patients With Acute Myocardial Infarction
A study testing discharge training in people with Cardiovascular Diseases, run by Manisa Celal Bayar University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- discharge training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2016to 30 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Evaluation of the Effect of Planned Discharge Training on Health Knowledge and Beliefs on Patients With Acute Myocardial Infarction
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.
Read the 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.
- Conditions
- Cardiovascular Diseases
- Being tested
- discharge training
- Keywords
- discharge training, acute myocardial infarction, compliance to drug, compliance to diet, CARRF-KL.
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
discharge trainingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Experimental group (EG) | Experimental | 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. Receives: Other: discharge training |
| Control group | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5-10 minutes
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.
Measured: 5-10 minutes
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.
Measured: 5-10 minutes
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.
Measured: 5-10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2019
- Study start1 Sep 2016
- Primary completion1 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manisa Celal Bayar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Serap Tuna, Manisa Celal Bayar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03985397
- Sponsor's protocol ID
- 20.478.486-332
- Status last verified
- Jun 2019
- First submitted
- 27 May 2019
- Last updated
- 13 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I do not have a plan
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Planned Discharge Training on Health Knowledge and Beliefs on Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT03985397
- Acronym / sponsor ID
- 20.478.486-332
- Conditions
- Cardiovascular Diseases
- Keywords
- discharge training, acute myocardial infarction, compliance to drug, compliance to diet, CARRF-KL.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Manisa Celal Bayar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 13 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Experimental group (EG) | Experimental | Other: discharge trainingAt 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. |
| Control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute myocardial infarction
- Discharge planned
- Minimal literacy
- 18-75 years of age
- No cancer or psychiatric diagnosis
Key exclusion criteria (7 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| discharge trainingProviding 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 | Other | Experimental group (EG) |
Primary outcome
Beliefs about Medication Compliance Scale
Time frame: 5-10 minutes
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
Time frame: 5-10 minutes
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
Time frame: 5-10 minutes
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.
Time frame: 5-10 minutes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2019.
- Individual participant dataSharing planned: No. I do not have a plan
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing discharge training in people with Cardiovascular Diseases, run by Manisa Celal Bayar University.
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 7 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: finished, as of the sponsor's last update on 13 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Beliefs about Medication Compliance Scale (time frame: 5-10 minutes). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jun 2019.