NCT04769219

Brief Summary

The aim of this study is to examine the effect of secondary prevention education given to individuals after acute myocardial infarction on physiological parameters, anxiety and quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 21, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 24, 2021

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

January 2, 2024

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

February 21, 2021

Last Update Submit

December 29, 2023

Conditions

Keywords

myocardial infarctionanxietyeducationQuality of Life

Outcome Measures

Primary Outcomes (2)

  • means of subjective anxiety scores

    Spielberg State- Trait Anxiety Scale. The total score between 0-19 obtained from the state anxiety scale shows that there is no anxiety, the total score between 20-39 indicates mild, the average score between 40-59 indicates moderate, and the total score between 60-79 indicates severe anxiety, and over 60 points are needed for professional help. The scores obtained from the trait anxiety scale vary between 20 and 80. A high score means a high and a low level means anxiety

    six months

  • means of subjective quality of life scores

    It consists of 35 items and the quality of life is based on physical activity (12 items), insecurity (9 items), emotional response (4 items), addiction (3 items), diet (3 items), concerns about medication (2 items), Each sub-dimension of MIDAS, which measures seven domains as (2 items), is scored between 0-100. High scores indicate poor health.

    six months

Secondary Outcomes (1)

  • means of subjective pain score

    six months

Other Outcomes (5)

  • means of blood pressure (mmHg)

    six months

  • means of total cholesterol (mg/dl)

    six months

  • means of HDL cholesterol (mg/dl)

    six months

  • +2 more other outcomes

Study Arms (2)

secondary prevention training

EXPERIMENTAL

Secondary prevention training will be given to 43 randomly selected patients between the fourth and sixth hours after AMI (in accordance with the patient's request). Secondary protection training will be carried out in two parts. First of all, the anatomical structure and functions of the heart, the definition of AMI, its causes, symptoms and risk factors will be explained, and then the issues to be considered after AMI will be explained. The content of the training will also be given to the participants in a written booklet.

Other: Secondary prevention training

nursing care

NO INTERVENTION

43 randomly selected patients will form the control group and this group will be provided with routine care and follow-up in the clinic. No intervention will be made.

Interventions

Secondary prevention training will be given after acute myocardial infarction

secondary prevention training

Eligibility Criteria

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

You may qualify if:

  • First time AMI and inpatient treatment in the coronary intensive care unit,
  • Not having received training after AMI \*
  • Being 18 years or older,
  • Speak Turkish,
  • No problem in verbal communication,
  • Absence of hearing loss,
  • Not being diagnosed with a psychiatric illness,
  • Being conscious,
  • Being volunteer to participate in the study,
  • Routine check of cholesterol, HDL, LDL, triglyceride results at the beginning of the study and at 6 months.

You may not qualify if:

  • Not having had AMI for the first time
  • Having received training after AMI
  • Not willing to participate in the study,
  • Cannot speak Turkish,
  • Problems in verbal communication,
  • Having hearing loss,
  • Having a diagnosis of psychiatric illness,
  • Unconsciousness.
  • Cholesterol, HDL, LDL, triglyceride results were not routinely checked at the start and 6 months of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Abant İzzet Baysal University

Merkez, Bolu, 14100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myocardial InfarctionAnxiety Disorders

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisMental Disorders

Study Officials

  • saadet can çiçek, Dr

    Abant Izzet Baysal University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
the participant did not know which group he was in.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: There are 2 groups as intervention and control
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2021

First Posted

February 24, 2021

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

August 31, 2021

Last Updated

January 2, 2024

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations