Protocol summary

Study aim
To assess the effect of education based on Pender’s health promotion model versus control group on health promoting behaviors in patients undergoing coronary angioplasty
Design
This is a randomized clinical trial, phase II, in which 96 eligible patients will be randomly assigned to the intervention and control groups
Settings and conduct
The eligible patients undergoing coronary angioplasty referring to the Farshchian Heart Hospital in Hamadan city during the study period will be enrolled in the trial and will be randomly assigned to the intervention and control groups through the block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 35 to 65 years, Undergoing coronary angioplasty, Literate, Exclusion criteria: Congenital heart disease, History of heart surgery, History of coronary angioplasty, Mental disorders
Intervention groups
Intervention group: Routine care after coronary angioplasty plus Pender Health Promotion-based training sessions include face-to-face training, question and answer, and video playback, 30 minutes each session three times at 5-day intervals Control group: Just routine care after coronary angioplasty plus
Main outcome variables
Primary outcome: Spiritual growth and individual self-actualizationو responsibility about health, interpersonal relationships, stress management, the amount of physical activity, adherence to a healthy diet

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N360
Registration date: 2020-07-04, 1399/04/14
Registration timing: prospective

Last update: 2020-07-04, 1399/04/14
Update count: 0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-22, 1399/05/01
Expected recruitment end date
2020-12-21, 1399/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on Pender’s health promotion model versus control group on health promoting behaviors in patients undergoing coronary angioplasty: a randomized clinical trial
Public title
Effect of education based on Pender’s health promotion model versus control group on health promoting behaviors in patients undergoing coronary angioplasty
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 35 to 65 years, Undergoing coronary angioplasty, Literate,
Exclusion criteria:
Congenital heart disease, History of heart surgery, History of coronary angioplasty, Mental disorders
Age
From 35 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
The patients will be randomly assigned to intervention and control groups using block randomization. For this purpose, we will prepare four sheets of paper, writing on two sheets the name of the intervention and on the other two sheets the name of the control. The paper sheets will be pooled, placed in a container, and randomly drawn one at a time for each patient without replacement until all four sheets are drawn. The four paper sheets will be then placed back into the container, and this action repeated until the sample size is reached.
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-04-15, 1399/01/27
Ethics committee reference number
IR.UMSHA.REC.1399.051

Health conditions studied

1

Description of health condition studied
Coronary angioplasty
ICD-10 code
Z98.61
ICD-10 code description
Coronary angioplasty status

Primary outcomes

1

Description
Spiritual growth and individual self-actualization
Timepoint
Before the intervention and 2 months later
Method of measurement
Using the standard questionnaire of health promotion behaviors

2

Description
Responsibility about health
Timepoint
Before the intervention and 2 months later
Method of measurement
Using the standard questionnaire of health promotion behaviors

3

Description
Interpersonal relationships
Timepoint
Before the intervention and 2 months later
Method of measurement
Using the standard questionnaire of health promotion behaviors

4

Description
Stress management
Timepoint
Before the intervention and 2 months later
Method of measurement
Using the standard questionnaire of health promotion behaviors

5

Description
The amount of physical activity
Timepoint
Before the intervention and 2 months later
Method of measurement
Using the standard questionnaire of health promotion behaviors

6

Description
Adherence to a healthy diet
Timepoint
Before the intervention and 2 months later
Method of measurement
Using the standard questionnaire of health promotion behaviors

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Routine care after coronary angioplasty plus Pender Health Promotion-based training sessions include face-to-face training, question and answer, and video playback, 30 minutes each session three times at 5-day intervals
Category
Treatment - Other

2

Description
Control group: Just routine care after coronary angioplasty plus
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Farshchian Heart Hospital in Hamadan city
Full name of responsible person
Zinat Yunesi
Street address
Farshchian Heart Hospital, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 1740
Email
zinat.yunesi@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Hamedan University of Medical Sciences
Full name of responsible person
Zinat Yunesi
Position
Student of Community Health Nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
zinat.yunesi@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Masoud Khodaveisi
Position
PhD in Nursing Training
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
khodaveisimasoud@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.ac.ir

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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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