Protocol summary

Summary
This is a clinical trial to evaluate the effect of family-centered education through multimedia software on patients clinical outcomes after myocardial infarction. 60 patients who have been acute myocardial infarction for the first time, will be selected with convenience sampling and will be randomly divided into 2 groups of 30 people. In the intervention group education to the patient and active family member through computer in three domains(nutrition, medication, exercise) will be done. In control group, the same educational content only to the patient(without family) will be taught. Three month after the intervention blood pressure, pulse pressure, blood lipids and ECG changes in two groups will be compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015031117873N3
Registration date: 2015-05-12, 1394/02/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-12, 1394/02/22
Registrant information
Name
Parvanrh Asgari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3808
Email address
p.asgari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy of Arak University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-11-22, 1394/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered education through multimedia software on patients clinical outcomes after myocardial infarction
Public title
The effect of family education on myocardial infarction patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The incidence of myocardial infarction that approved by a doctor; The incidence of acute myocardial infarction for the first time; Lack of speech problems, blindness and deafness of the patient and active family member; Exclusion criteria: Psychological crisis during the study; The lack of providing additional information due to physical deterioration.
Age
From 29 years old to 69 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Arak University of Medical Sciences, Sardasht,
City
Arak
Postal code
Approval date
2014-05-05, 1393/02/15
Ethics committee reference number
93-162-7

Health conditions studied

1

Description of health condition studied
Myocardial infarction
ICD-10 code
I21.0, I21
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Blood pressure
Timepoint
Before and three month after the intervention
Method of measurement
Millimeters of mercury with a mercury manomete

2

Description
Pulse pressure
Timepoint
Before and three month after the intervention
Method of measurement
Millimeters of mercury with a mercury manomete

3

Description
Blood lipids
Timepoint
Before and three month after the intervention
Method of measurement
Blood test

4

Description
Body Mass Index
Timepoint
Before and three month after the intervention
Method of measurement
Kilogram with electronic scales

5

Description
ECG changes
Timepoint
Before and three month after the intervention
Method of measurement
ECG machine

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group education to the patient and family member on three domains(nutrition,medication,exercise) in three sessions of 30-45 minute will be done.
Category
Lifestyle

2

Description
In control group education to thr patient(without family) on three domains(nutrition,medication,exercise) in three sessions of 30-45 minute will be done.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir kabir hospital
Full name of responsible person
Parvaneh asgari
Street address
Sardasht, Faculty of Nursing and Midwifery, Arak University of Medical Sciences
City
Arak

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr.rafei
Street address
Arak; Rahahan Sq;Alamolhoda St;Arak University of Medical Sciences
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Parvaneh Asgari
Position
Instructor
Other areas of specialty/work
Street address
Arak; Rahahan Sq;Alamolhoda St;Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 3417 3505
Fax
Email
p_marjan@ymail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parvaneh Asgari
Position
Msc of critical care nursing
Other areas of specialty/work
Street address
Arak; Rahahan Sq; Alamolhoda St; Arak University of Medical Sciences
City
Arak
Postal code
Phone
+98 86 3417 3505
Fax
Email
p_marjan@ymail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Parvaneh Asgari
Position
Instructor
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address

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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