NCT03985397

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Sep 2016

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2017

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2017

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

May 27, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 13, 2019

Completed
Last Updated

June 13, 2019

Status Verified

June 1, 2019

Enrollment Period

1.2 years

First QC Date

May 27, 2019

Last Update Submit

June 12, 2019

Conditions

Keywords

discharge trainingacute myocardial infarctioncompliance to drugcompliance to dietCARRF-KL.

Outcome Measures

Primary Outcomes (4)

  • 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.

    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.

    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.

    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.

    5-10 minutes

Study Arms (2)

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.

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.

Interventions

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

Experimental group (EG)

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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).
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
internal medicine nursing lecturer doctor

Study Record Dates

First Submitted

May 27, 2019

First Posted

June 13, 2019

Study Start

September 1, 2016

Primary Completion

December 1, 2017

Study Completion

December 30, 2017

Last Updated

June 13, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

I do not have a plan