Myocardial infarction is the cause of numerous heart diseases, which can bring patients back to treatment centers even long after the hospital discharge. Due to reduced severity of disease signs and symptoms and the passage of time, patients’ adherence to self-care behaviors is diminished in most cases, which will result in worsening symptoms and signs and even increased risk of re-hospitalization. Methodology: This study was a randomized clinical trial conducted on 120 patients with myocardial infarction who were randomly divided into two 60-member intervention and control groups. Inclusion Criteria: definitive diagnosis of myocardial infarction by a cardiologist for the first time; hospitalization in cardiac wards or intensive care units; stability of the patient's hemodynamic status; not receiving nutritional consultation by another person. Exclusion criteria: suffering from untreated heart failure; uncontrolled arrhythmias; severe and persistent chest pain or discontinuation of cooperation; suffering from an underlying; if interacted to the consultation plan, it will exit from study; death during the study. Instruments: The MEDFICTS questionnaire was filled out before and two months after the invention. The intervention group was invited to participate in 3 nutritional counseling sessions. Two months after counseling sessions, weekly telephone follow-ups will be done. The control group will receive only routine care.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201502035987N17
Registration date:2015-07-01, 1394/04/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-07-01, 1394/04/10
Registrant information
Name
Shahrzad Ghiyasvandian
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6692 7171
Email address
shghiyas@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2015-04-19, 1394/01/30
Expected recruitment end date
2015-07-21, 1394/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of nutritional consulting program on nutritional behavior and relationship with re-hospitalization among patients with Myocardial Infarction
Public title
Effects of nutritional consulting program on nutritional behavior and relationship with rehospitalization among patients with Myocardial Infarction
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion / Exclusion: Inclusion Criteria: definitive diagnosis of myocardial infarction by a cardiologist for the first time; hospitalization in cardiac wards or intensive care units; stability of the patient's hemodynamic status; not receiving nutritional consultation by another person. Exclusion criteria: suffering from untreated heart failure; uncontrolled arrhythmias; severe and persistent chest pain or discontinuation of cooperation; suffering from an underlying; if interacted to the consultation plan, it will exit from study; death during the study.
Age
From 36 years old to 80 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Based on simple randomly, according to odd and even numbers, individuals were selected to the control and intervention group
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Tehran, Amir Abad, Keshavarz Blvd.
City
Tehran
Postal code
1419733171
Approval date
2015-02-10, 1393/11/21
Ethics committee reference number
9111196003122574
Health conditions studied
1
Description of health condition studied
Myocardial Infraction
ICD-10 code
I219
ICD-10 code description
Diseases of the circulatory system
Primary outcomes
1
Description
Nutritional behavior
Timepoint
Two months
Method of measurement
Questionnaire
Secondary outcomes
1
Description
Re-hospitalization
Timepoint
two months
Method of measurement
Self-reported
Intervention groups
1
Description
Intervention group: This study is a randomized clinical trial investigating 120 patients with myocardial infarction. Using the research tools, the researcher measured subjects’ nutritional behavior and hospital readmission before and two months after nutritional counselling. In this study, the nutritional counseling program included three 90-minute sessions during one week. Moreover, if necessary, patients’ questions will be answered after individual counseling sessions in person and through telephone follow-ups.
Category
Prevention
2
Description
Control group: These patients will receive routine care including giving an explanation of the prescription and make a recommendation to see the doctor at the appointed time for the next visit. Data will be collected using the self-report method and a questionnaire.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeyni Hospital
Full name of responsible person
Roghaye Eghbali
Street address
Tehran, Tohid Square.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Masood Younesian
Street address
The central building of Tehran University of Medical Sciences, Qods Street, Keshavarz Street, Tehran, Iran
City
Tehran
Grant name
000
Grant code / Reference number
000
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Sciences
Full name of responsible person
Roghaye Eghbali
Position
Student of Nursing in Master of Science
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Street, Tohid square, Tehran, Iran
City
Tehran
Postal code
3158657796
Phone
+98 58 3635 0447
Fax
+98 000
Email
Eghbali69Roghaye@yahoo.com
Web page address
000
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery,Tehran University of Medical Scienses
Full name of responsible person
Shahrzad Ghiyasvandian
Position
PHD
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Tehran University of Medical Sciences, Nosrat Street, Tohid square, Tehran, Iran
City
Tehran
Postal code
9468148331
Phone
+98 21 6642 0739
Fax
+98 66904252
Email
Shghiyas@tums.ac.ir
Web page address
000
Person responsible for updating data
Contact
Name of organization / entity
School of Nursing and Midwifery, Tehran University of Medical Science
Full name of responsible person
Roghaye Eghbali
Position
Master Sciences Student of Nursing
Other areas of specialty/work
Street address
School of Nursing and Midwifery of Tehran University of Medical Sciences, Nosrat Street, Tohid square, Tehran, Iran
City
Tehran
Postal code
1419733171
Phone
+98 58 3635 0447
Fax
+98 000
Email
Eghbali69Roghaye@yahoo.com
Web page address
00000
Sharing plan
Deidentified Individual Participant Data Set (IPD)