Protocol summary

Summary
This study is an interventional experimental one which aimed to determine the impact of an educational intervention based on Health Promotion Model, to improve self-care, health promotion behaviors and quality of life of patients after coronary artery bypass surgery. In this study, 220 patients were divided randomly into two groups, A and B.The intervention group will be trained according to the results of self-care and health promoting behavior questionnaire. The program will be 6 weeks and every week a meeting.The intervention group (n=110) will be split into three groups. Training sessions will be held on 60 to 90 minutes a session per week. For training in the intervention group manual, pamphlet, practical exercises and group discussions will be used. For each session, an item will be selected and trained. Patients will be followed for 3, 6 and 12 months after the intervention. Study outcomes are self-care behaviors, quality of life and rehospitalization rates for patients following heart surgery.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201501248742N6
Registration date: 2015-05-17, 1394/02/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-05-17, 1394/02/27
Registrant information
Name
Fereshteh Majlessi
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8898 9134
Email address
majlesif@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
International Campus of Tehran University of Medical Sciences
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on health promotion model, on improvement of self-care, health promoting behaviors and quality of life in patients after coronary artery bypass surgery
Public title
Self-care of patients after cardiac surgery
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: willingness to participate in the study; passing one month after the last surgery; Heart surgery for the first time. Exclusion Criteria: Patients with mental and physical disabilities; Emergency situation; The use of psychotropic medications
Age
From 40 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 220
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
Tehran University of Medical Sciences
Street address
Keshavarz Blvd., Qods Ave., Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2015-02-10, 1393/11/21
Ethics committee reference number
9123489001-138444

Health conditions studied

1

Description of health condition studied
Cardiac surgery patients
ICD-10 code
Z50.0
ICD-10 code description
Cardiac rehabilitation

Primary outcomes

1

Description
Self-care
Timepoint
Before Intervention, Three months after the intervention, six month after the intervention, Twelve month after the intervention
Method of measurement
Questionnaire

2

Description
Health promoting behaviors
Timepoint
Before Intervention, Three months after the intervention, six month after the intervention, Twelve month after the intervention
Method of measurement
Questionnaire

3

Description
Quality of life
Timepoint
Before The Intervention3, 6, 12 Months After Intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Reduce Readmissions
Timepoint
Before Intervention, Three months after the intervention, six month after the intervention, Twelve month after the intervention
Method of measurement
Questionnaire

Intervention groups

1

Description
The intervention group will be trained according to the results of self-care and health promoting behavior questionnaire. Educational intervention will take placefor6 weeks and a training session will be 60 to 90 minutes per week. For training in the intervention group manual, pamphlet, practical exercises and group discussions will be used. We will develop a special topic for each session.
Category
Lifestyle

2

Description
control group will not receive any intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mazandran Heart Center Hospital
Full name of responsible person
Rahman Ghafari
Street address
Mazandran Heart Center Hospital, Artesh Boulevard, Sari, Mazandran
City
Sari

2

Recruitment center
Name of recruitment center
Tuba Clinic
Full name of responsible person
Zahra Mosavian
Street address
Tuba Clinic, Khazar Boulevard, Sari, Mazandran
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
International Campus of Tehran University of Medical Sciences
Full name of responsible person
Mohammadreza Hadian
Street address
Valiasr Ave., Mozaffar North Street, No 124, Third Floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
International Campus of Tehran 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
School of Public Health Tehran University of Medical Sciences
Full name of responsible person
Dr. Fereshteh Majlessi
Position
Academic member
Other areas of specialty/work
Street address
Department of Health education and promotion, west fourth floor, School of public health, Tehran University of Medical Sciences
City
Tehran
Postal code
141554664
Phone
+98 21 8898 9134
Fax
Email
Dr_F_Majlessi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
School of Public Health Tehran University of Medical Sciences
Full name of responsible person
Dr Fereshteh Majlessi
Position
MD
Other areas of specialty/work
Street address
Department of Health education and promotion, west fourth floor, School of public health, Tehran University of Medical Sciences
City
Tehran
Postal code
141554664
Phone
+98 21 8898 9134
Fax
Email
Dr_F_Majlessi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Fereshteh Majlessi
Position
MD
Other areas of specialty/work
Street address
Department of Health education and promotion, west fourth floor, School of public health, Tehran University of Medical Sciences
City
Tehran
Postal code
141554664
Phone
+98 21 8898 9134
Fax
Email
dr_f_majlessi@yahoo.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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