Protocol summary

Study aim
Determining the effect of self-efficacy-based education on self-care and self-efficacy in patients with hypertension Referring to community health centers
Design
This clinical trial study was carried out with the participation of hypertensive patients referred to selected health centers (2 health centers) in Mashhad in 1396. The sampling method will be such that at first five health centers of the urban community of Mashhad will be selected randomly from two centers in accordance with the health center of the province, and then, from the prevention of the dissemination of information, from each urban community health center Three centers will be randomly selected for intervention and control groups. Sixty people with hypertension in these centers are enrolled and randomly divided into intervention and control groups.
Settings and conduct
Of the five health centers of the urban community of Mashhad, two centers will be randomly selected (lotteries) in coordination with the health center of the province.and then, because of the prevention of the dissemination of information, from each health center of the urban community, three centers will be randomly selected for intervention and control groups.In the experimental group, a self-efficacy training program based on the structures of social cognitive theory of Bandura (successful experience; promising experience; verbal encouragement and physical and emotional states) for a period of (4 weeks) a weekly meeting and each meeting will be held for 45 minutes. In the control group, the routine care and education of the center will be provided. In both groups before intervention and after the fourth week immediately after completing the training session and one month later, self-efficacy was assessed using a general self-efficacy questionnaire and self-care will be measured by self-care adjustment questionnaire for patients with hypertension.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Aged 70-40 years old; Diagnosing Hypertension is at least one year old; Hypertension is confirmed by a cardiologist; Active case of high blood pressure disease in the health center; Have not severe disorder cognition. Exclusion criteria: During the past 6 months, have not participated in the same educational program as the study program;Unwilling to participate in the study.
Intervention groups
Intervention group: 30 patients with hypertension who participate in The educational intervention was designed based on the self-efficacy theory and was performed in four educational sessions lasting 45 minutes by group discussion; brainstorming; questions and answers. Control group:30 hypertensive patients who is not receive any special training by researchers.
Main outcome variables
Self- efficacy; Self-care

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171117037513N1
Registration date: 2018-03-01, 1396/12/10
Registration timing: retrospective

Last update: 2018-03-01, 1396/12/10
Update count: 0
Registration date
2018-03-01, 1396/12/10
Registrant information
Name
Fatemeh Farazian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3852 8512
Email address
farazianf931@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-12-31, 1396/10/10
Expected recruitment end date
2018-01-20, 1396/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Educational Intervention based on the Bandura's self-efficacy pattern on self-care and self-efficacy of patients with hypertension.
Public title
Education based on the theory of self efficacy on self efficacy and self-care in Hypertension patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Aged 70-40 years old Hypertension is confirmed by a cardiologist An active file of high blood pressure disease in the health center Have a family live in Mashhad
Exclusion criteria:
During the past 6 months, he has not participated in the same training program as the training program. Unwilling to participate in the study.
Age
From 40 years old to 70 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
Table of random numbers will be used For randomization
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 Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2017-12-23, 1396/10/02
Ethics committee reference number
IR.MUMS.REC.1396.320

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension

Primary outcomes

1

Description
Self- efficacy
Timepoint
Before, immediately and four weeks after intervention
Method of measurement
Sherer General Self-efficacy scale

2

Description
Self-care
Timepoint
Before, immediately and four weeks after intervention
Method of measurement
Modified questionnaireSelf-care for patients with high blood pressure

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: In intervention group, 30 patients with high blood pressure who participate in 4 45-minute training sessions. The self-efficacy training program is based on the structures of the social cognitive theory of Bandura (successful experience; promising experience; verbal encouragement and emotional and physical states). In the training sessions: group discussion; sentiment and questioning are used.
Category
Lifestyle

2

Description
Control group: The control group only will receive routine care
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Mashhad No 1 Health Center
Full name of responsible person
Dr Naser Amini
Street address
No 1. Health center, Next to shahrbani Town, Vakilabad Blvd,Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
۹۱۷۷۸۹۹۱۹۱
Phone
+98 51 3501 8011
Fax
Email
m1hcenter@mums.ac.ir
Web page address

2

Recruitment center
Name of recruitment center
Mashhad No3 Health Center
Full name of responsible person
Dr. Brat Ali Arabnejad
Street address
Health Center No 3, Khayyam Blvd, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9185837715
Phone
+98 51 3763 4007
Fax
+98 51 3763 0039
Email
m3hcenter@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Vice chancellor for research, Ghoraishy Building, University St
City
Mashhad
Province
Razavi Khorasan
Postal code
۳۴۵ - ۹۱۳۷۵
Phone
+98 51 3841 1538
Fax
Email
vcresearc@mums.ac.ir
Web page address
http://v-research.mums.ac.ir/index.php
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Fateme Farazian
Position
Master of Science Student in Public Health
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3607 8926
Email
Farazianf931@mums.ac.ir
Web page address
http://nurse.mums.ac.ir/index.php

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Emami Moghadam
Position
Master of Science in Nursing
Latest degree
Master
Other areas of specialty/work
Medical Education
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
+98 51 3852 8512
Phone
+98 51 3607 8926
Email
Emamiz@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Fatemeh Farazian
Position
Master of Science Student in Public Health
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Mashhad Faculty of Nursing and Midwifery, Ebn-e Sina St, Doktora Crossroads
City
Mashhad
Province
Razavi Khorasan
Postal code
+98 51 3852 8512
Phone
+98 51 3607 8926
Email
Farazianf931@mums.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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