Protocol summary

Study aim
Design
Settings and conduct
Participants/Inclusion and exclusion criteria
Intervention groups
Main outcome variables

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160528028133N1
Registration date: 2017-12-12, 1396/09/21
Registration timing: retrospective

Last update: 2017-12-12, 1396/09/21
Update count: 0
Registration date
2017-12-12, 1396/09/21
Registrant information
Name
Reza Mohammadi
Name of organization / entity
Shahrekord Medical University
Country
Iran (Islamic Republic of)
Phone
+98 38133424140
Email address
st-mohammadi.r@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Of the project costs for the project will be approved by the University
Expected recruitment start date
2016-12-21, 1395/10/01
Expected recruitment end date
2017-01-20, 1395/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of empowerment program based on the health belief model on activity daily living, self efficacy and perceived satisfaction of peoples with acute coronary syndrome
Public title
The impact of the empowerment program on heart disease
Purpose
Health service research
Inclusion/Exclusion criteria
Age
From 90 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Shahrekord Medical University
Street address
Chaharmahal Bakhtiari state, Shahrekord, Rarmateh
City
Shahrekord
Postal code
8815713471
Approval date
2017-01-24, 1395/11/05
Ethics committee reference number
IR.SKUMS.1395.144

Health conditions studied

1

Description of health condition studied
Acute coronary syndrome
ICD-10 code
I24.9
ICD-10 code description
acute ischemic heart disease unspecified

Primary outcomes

1

Description
Empowerment program
Timepoint
Immediately a month and three months after the intervention
Method of measurement
questionnaire

Secondary outcomes

1

Description
Activities of Daily Living
Timepoint
Immediately a month and three months after the intervention
Method of measurement
Barthel index

2

Description
Self-efficacy
Timepoint
Immediately a month and three months after the intervention
Method of measurement
Self-efficacy questionnaire for heart patients

3

Description
Perceived satisfaction
Timepoint
Immediately a month and three months after the intervention
Method of measurement
Perceived satisfaction questionnaire

Intervention groups

1

Description
Empowerment sessions based on Health Belief Model constructs will be conducted in 7 sessions in the intervention group. Strategies for understanding heart disease, assessing risk, severity and consequences of illness, assessing the benefits and barriers o
Category
Rehabilitation

2

Description
There will be no intervention in the control group. And the current care in the hospital will be considered.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hajar Hospital in Shahrekord
Full name of responsible person
reza mohammadi
Street address
Chaharmahal Bakhtiari؛ Shahrekord Hajar Hospital
City
shahrekord

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Reza Mohammadi
Street address
Iran
City
Shahrekord
Grant name
ندارد
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahrekord 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
Shahrekord University of Medical Sciences
Full name of responsible person
Reza Mohammadi
Position
Masters student
Other areas of specialty/work
Street address
Iran
City
Shahrekord
Postal code
8815713471
Phone
+98 38 1334 2414
Fax
+98 38 1334 9506
Email
mohammadireza47@gmail.com
Web page address
www.skums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Reza Mohammadi
Position
Masters student
Other areas of specialty/work
Street address
iran
City
Shahrekord
Postal code
8815713471
Phone
+98 38 1334 2414
Fax
+98 38 1334 9506
Email
mohammadireza47@gmail.com
Web page address
www.skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences
Full name of responsible person
Reza Mohammadi
Position
Masters student
Other areas of specialty/work
Street address
Chaharmahal Bakhtiari state؛ Shahrekord؛ Rarmateh
City
Shahrekord
Postal code
8815713471
Phone
+98 383813342414
Fax
+98 38 1334 9506
Email
mohammadireza47@gmail.com
Web page address
www.skums.ac.ir

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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