Protocol summary

Summary
This research is a clinical trial with two groups to assess the effect of intervention with cardiac rehabilitation (as independent variable) on the self esteem and self efficacy (as dependent variable). The study population was all the elderly patients with the diagnosis of cardiac coronary arteries disease hospitalized in the cardiac intensive care unit , and the elderly who were refered to the rehabilitation center after being discharged from the cardiac intensive care unit. Inclusion criteria: age above 60 , this is for the first time that the cardiac arteries disease is being confirmed by a cardiologist. Exclusion criteria: having orthopedic or mobility problems such as rheumatic diseases , having non pharmaceutical intervention to treat the disease. The number of sample in this research is considered to be 30 patients in each group and also 10 percent is considered as the falling number. Impact of cardiac rehabilitation program Intervention will be assessed after 24 sessions (8 weeks). This program in case of being effective can be considered as a non pharmaceutical solution to improve the self esteem and self efficacy of the elderly who suffer with coronary arteries disease in the nursing care implementation program.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016120731290N1
Registration date: 2017-09-04, 1396/06/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-09-04, 1396/06/13
Registrant information
Name
Halimeh Khodadadian
Name of organization / entity
Shahid sadoughi Yazd University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 1751
Email address
halimeh-khodadadian@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Deputy Of Shahid Sadoughi University Of medical Sciences, Yazd, Iran
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-01-19, 1395/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of cardiac rehabilitation on self-esteem and self-efficacy in elder coronary patient
Public title
The effects of cardiac rehabilitation on self-esteem and self-efficacy in elder coronary patient
Purpose
Supportive
Inclusion/Exclusion criteria
Entry criteria into the study : age above 60; having the ability to understand and speak in Persian; this is for the first time that the cardiac arteries disease is being confirmed by a cardiologist. Exit criteria from the study : having mental illness; having orthopedic or mobility problems such as rheumatic diseases; having a history of confusion and forgetfulness ; having non pharmaceutical intervention to treat the disease; using drugs related to mental disorders.
Age
From 60 years old to 100 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Not 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
Research Ethics Committee shahid sadoughi Yazd University of Medical Sciences
Street address
Sadoughi shahid sadoughi Yazd University of Medical Sciences School of Nursing
City
yazd
Postal code
Approval date
2016-10-10, 1395/07/19
Ethics committee reference number
IR.SSU.REC.1395.121

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease
ICD-10 code
I20, I21,
ICD-10 code description
Disorders of arteries, arterioles and capillaries in diseases classified elsewhere

Primary outcomes

1

Description
Self-esteem
Timepoint
Before intervention-Two months after the intervention.
Method of measurement
Rosenberg Self-Esteem Scale

2

Description
Self-efficacy
Timepoint
Before intervention-two months after the intervention
Method of measurement
Self-efficacy questionnaire heart Sullivan

Secondary outcomes

empty

Intervention groups

1

Description
Rehabilitation programe of cardiovascular patients are carried out in 3 stages. The first stage starts before discharging patients from hospitals and patients are advised on sexual and physical allowable levels, proper diet, proper use of medicine and how to quit cigarrette.In the second stage which is related to the period of time after being discharged from hospitals, patients take exercise with minimum 12 sessions under physician surveillance. This stage can be implemented at home based on the patients willingness.likely questions will be answered in the third stage by holding training sessions and patients are examined and controled regrading factors which cause danger including high blood pressure, triglisirid and fast blood sugar.
Category
Rehabilitation

2

Description
Patients in the control group before discharging patients from hospitals and patients are advised on sexual and physical allowable levels, proper diet, proper use of medicine and how to quit
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Cardiac Rehabilitation Clinic Iran
Full name of responsible person
halimeh khodadadian - Masters student
Street address
Avenue bagh eram، Avenue tabibesfahani، Avenue ghaemmagham frahani
City
esfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Sadoughi Yazd University of Medical Sciences
Full name of responsible person
Habib Necokar
Street address
Alam Sq،Safaieh، Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoughi Yazd 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
Yazd,shahid sadoughi University of Medical Sciences
Full name of responsible person
Zohreh Kalani
Position
Master of scince nursing education, member of scientific board, Yazd Shahid sadoughi college of nurs
Other areas of specialty/work
Street address
Yazd ,timsar Fallahi Avenue ,Buali Avenu, college of nursing
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
Kalani_z@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Sadoughi Yazd University of Medical Sciences
Full name of responsible person
Zohreh Kalani
Position
Master of sceince in nursing education
Other areas of specialty/work
Street address
Yazd,safaeie,timsar Falahi Avenu,Buali Avenu,college of nursing and midwifery
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
kalani_z@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Yazd,safaeie,timsar Falahi Avenu,Buali Avenu,college of nursing and midwifery
Full name of responsible person
Halimeh Khodadadian
Position
Master student of elderly nursing
Other areas of specialty/work
Street address
Safaeei,timsar Fallahi Avenu, Boali Avenu
City
Yazd
Postal code
Phone
+98 35 3824 1751
Fax
Email
halimeh-khodadadian@ssu.mui.ac.ir khodadadian852@gmail.com
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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