Protocol summary

Summary
Objective: This research aimed to evaluate effect of preventing coronary artery disease multimedia software on adjusting risk factors in patients with coronary artery disease. Design: This two phases (before and 3 months after the intervention), quasi-experimental study will conduct on 32 patients with coronary artery disease. Patients were selected randomly, among all patients with coronary artery disease referring to Chamran hospital, based on inclusion criteria. Main outcome measures (primary and secondary outcome variables): primary outcome of this study is related coronary artery disease risk factors. Participants including major eligibility criteria: Inclusion criteria were: Acute Coronary Syndrome(acute myocardial infarction with elevated ST segment, myocardial infarction without ST elevation and unstable angina); having computer at home; willingness for participating in the study; being oriented of their disease; knowing Persian language; not having mental retardation, disabilities, blindness, Deafness and active psychological disease; not having thyroid and digestive disease; not having complications of acute coronary syndrome like acute pulmonary edema and congestive heart disease. Exclusion criteria were unwillingness for participating in the study and filling questionnaires incompletely. Setting and conduct (Intervention): researcher will conduct the intervention in two stages of designing the software and providing that for patients who have eligible criteria for the study. After three months, all tests performed before the intervention will be repeated in accordance with the standards.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017072220833N3
Registration date: 2017-11-19, 1396/08/28
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-11-19, 1396/08/28
Registrant information
Name
Samira Abbasi
Name of organization / entity
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3228 7822
Email address
s.abbasi@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Isfahan University of Medical Sciences
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of preventing coronary artery disease multimedia software on adjusting risk factors in patients with coronary artery disease
Public title
Effect of preventing coronary artery disease multimedia software on adjusting risk factors in patients with heart disease
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Acute Coronary Syndrome(acute myocardial infarction with elevated ST segment, myocardial infarction without ST elevation and unstable angina); having computer at home; willingness for participating in the study; being oriented of their disease; knowing Persian language; not having mental retardation, disabilities, blindness, Deafness and active psychological disease; not having thyroid and digestive disease; not having complications of acute coronary syndrome like acute pulmonary edema and congestive heart disease. Exclusion criteria: unwillingness for participating in the study and filling questionnaires incompletely.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Hezarjarib Avenue, Isfahan University Of Medical Sicences, Isfahan
City
Isfahan
Postal code
Approval date
2016-11-21, 1395/09/01
Ethics committee reference number
194265

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Diseases of arteries, arterioles and capillaries

Primary outcomes

1

Description
Blood pressure
Timepoint
before the intervention and three month after the intervention
Method of measurement
Mercury barometric

2

Description
Blood Triglyceride
Timepoint
before the intervention and three month after the intervention
Method of measurement
Spectrophotmetery

3

Description
Low-density lipoprotein(LDL)
Timepoint
before the intervention and three month after the intervention
Method of measurement
Spectrophotmetery

4

Description
High-density lipoprotein(HDL)
Timepoint
before the intervention and three month after the intervention
Method of measurement
Spectrophotmetery

5

Description
Cholesterol
Timepoint
before the intervention and three month after the intervention
Method of measurement
Spectrophotmetery

6

Description
Fasting blood sugar
Timepoint
before the intervention and three month after the intervention
Method of measurement
Spectrophotmetery

Secondary outcomes

empty

Intervention groups

1

Description
32 patients will be selected randomly based on inclusion criteria then demographic questionnaire will be filled and multimedia software of coronary artery disease will be given to the patients in the test group. patients will visit the physician, in order to evaluate their general health based on checklist, one day before and three month after the intervention.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Chamran hospital
Full name of responsible person
Dr Masoumeh Sadeghi
Street address
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mahin Moeini
Street address
Hezarjarib Avenue, Isfahan University of Medical Sciences
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Isfahan 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
Isfahan University Of Medical Sciences
Full name of responsible person
Mahin Moeini
Position
Assistatant professor, Nursing and Midwifery Care Research Center
Other areas of specialty/work
Street address
Hezarjarib Ave, Isfahan University Of Medical Sciences, Isfahan
City
Isfahan
Postal code
Phone
+98 31 3792 7621
Fax
Email
moeini@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Samira Abbasi
Position
Msc of psychiatric Nursing
Other areas of specialty/work
Street address
Hezarjarib Ave, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 3792 7607
Fax
Email
samiraabbasi6853@gmail.com
Web page address

Person responsible for updating data

Contact

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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