Protocol summary

Study aim
Determining the impact of multimedia education on quality of life and self-efficacy in patients with MI.
Design
Clinical trials with community based and pragmatic control group, with parallel groups, randomized
Settings and conduct
This intervention will be carried out in the CCU of the Ayatollah Kashani Hospital and the ICU. After obtaining the relevant permissions of the researcher during the week, go to section referring to the entry criteria, they will look at their units Selects the available sampling. After explaining the goals and methods of work, patients and patients will be informed of the consent of the name of the patient. Then, the questionnaire on quality of life and self-efficacy is completed by the peer reviewer. In the intervention group, a 10-person training session with a multimedia program called a 2 to 3 hour one-day workshop for the patient. Member family activist is held. At the end of the workshop, the training file will be given to patients and patients. In the intervention group, in addition to the workshop, telephone interviews are also conducted for 1 month by the doctor. There is no intervention in the control group and they receive all nursing routine care. Quality of life and self-efficacy of patients after a specified time (one month) will be measured and recorded using the Sherer General Self-efficacy Questionnaire and Quality of Life in Minnesota, respectively.
Participants/Inclusion and exclusion criteria
Detection of cardiovascular disease admission in CCU section possibility of telecommunication.
Intervention groups
In the intervention group, a training session is held with groups of 10 people per day for 2 to 3 hours for the patient or active member of the family. There is no intervention in the control group and they receive all nursing routine care.
Main outcome variables
Quality of life; self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181122041720N2
Registration date: 2019-06-22, 1398/04/01
Registration timing: prospective

Last update: 2019-06-22, 1398/04/01
Update count: 0
Registration date
2019-06-22, 1398/04/01
Registrant information
Name
Shirin Madadkar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3338 2382
Email address
shirinmadadkar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-11, 1398/04/20
Expected recruitment end date
2019-09-11, 1398/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of multimedia education on the family- centered approach of telephoning (tele nursing) on quality of life and self-efficacy of patients with myocardial infarction
Public title
The effect of multimedia education in the patients with myocardial infarction
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of myocardial infarction Admitted to the ccu section Ability to make phone calls Computer access point
Exclusion criteria:
Disclaimer Death of the patient Extended hospitalization time
Age
From 45 years old to 88 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
Samples will be entered into the study with a simple sampling method based on the criteria for entering the study and will be based on the random numbers table in the groups (intervention and control).
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
National Ethics Committee for Biomedical Research
Street address
Rahmatieh, Islamic Azad University, Shahrekord Branch
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.IAU.SHK.REC.1398.001

Health conditions studied

1

Description of health condition studied
Myocardial infarction
ICD-10 code
122.0
ICD-10 code description
Myocardial infarction

Primary outcomes

1

Description
Quality of Life
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Minnesota Questionnaire

2

Description
Self-efficacy
Timepoint
Before the intervention and one month after the intervention
Method of measurement
Scherer self-efficacy questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In an intervention group, a training session with groups of 10 persons was conducted through multimedia software called a 2 to 3 hour one-day workshop for the patient and active member of the family in the date and time coordinated in the training class available in the department. Gets At the end of the workshop, patient and family questions will be answered in relation to the educational content provided. An educational file is also provided to patients and patients to be reviewed in the home. In the intervention group, in addition to the intervention workshop, the intervention is also conducted for 1 month (once a week) by the peer reviewer. Quality of life and self-efficacy of patients after a specified time (one month) were measured and recorded in each group using the Sherer General Self-efficacy Questionnaire and Minnesota's Quality of Life, respectively
Category
Rehabilitation

2

Description
Control group: There is no intervention in the control group and all nursing routine care is received. Quality of life and self-efficacy of patients after a specified time (one month) were measured and recorded using the Sherer General Self-efficacy Questionnaire and Minnesota's Quality of Life, respectively.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Kashani Hospital and Hagar Shahrekord Hospital
Full name of responsible person
Shirin Madadkar
Street address
Nursing Street, Ayatollah Kashani Hospital and Hagar Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
Kashani@skums.ac.it

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Hossein Sazegar
Street address
Rahmatieh, Islamic Azad University of Shahrekord
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
info@skums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Research Deputy of Islamic Azad University, Shahrekord Branch
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rahmatieh, Islamic Azad University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
shirinmadadkar@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rahmatieh, Islamic Azad University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
shirinmadadkar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Shirin Madadkar
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rahmatieh, Islamic Azad University
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8813733395
Phone
+98 38 3336 1000
Email
shirinmadadkar@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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