Protocol summary

Summary
Introduction: High blood pressure, a major problem in all human societies. The most important cause of heart failure, kidney and brain strokes. Behavioral modification model, to help the healing process of chronic patients. The aim of this study, Effect of Education Based on BAZNEF Model on Blood Pressure and lifestyle in Patient with Hypertension. Methods: This case-control clinical trial on 100 patients with high blood pressure (50 intervention and 50 control) referred to health centers of Kashan in 1394 done. The data collection tool, lifestyle questionnaire (LSQ) that its validity by factor analysis and reliability Alpha 0/87 approved. The basic information, lifestyle and blood pressure were collected from the groups of intervention (education based on Basnef model) for the intervention and control groups, routine follow-up is done. The blood pressure (weeks 1, 3 and 5) and again after 1 month intervention, lifestyle and blood pressure is controlled.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201409094655N7
Registration date: 2016-01-25, 1394/11/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-01-25, 1394/11/05
Registrant information
Name
Mohsen Taghadosi
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
taghadosi_m@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kashan University of Medical Sciences
Expected recruitment start date
2015-12-22, 1394/10/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on Baznef model on blood pressure and lifestyle in patient with hypertension.
Public title
Effect of education based on Baznef model on blood pressure and lifestyle in patient with hypertension.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: The desire to participate in the study; primary hypertension (high blood pressure that has no known cause); age of 65-18 years; they have at least 6 months of diagnosis; Ability to understand and speak; The lack of physical and mental debilitating diseases known; be able to understand and speak the Persian language; Patients who score their lifestyle, according to Life Style Questionnaire (LSQ) is less than 170. Exclusion criteria: unwillingness to continue the study; participate in the study or other training courses during study; The absence of training sessions (one session and more); joint disease or condition during the study's lead to hospitalization; Change in dosage or type of medication therapy during the study.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Individuals in the intervention and control groups, randomly allocated blocks (blocks 4-procurement and selection will be based on them)

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kashan University of Medical Sciences
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
kashan
Postal code
Approval date
2015-12-22, 1394/10/01
Ethics committee reference number
IR.KAUMS.REC.1394.134

Health conditions studied

1

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

Primary outcomes

1

Description
life style
Timepoint
Baseline and 1 month after intervention
Method of measurement
lifestyle questionnaire

2

Description
blood pressure
Timepoint
Baseline, weeks 1, 3, 5 and 1 month after the intervention
Method of measurement
In compliance with all standards of JNC 7 using a mercury manometer adults model F.BOSCH (GERMANY), which was calibrated with mercury healthy.

Secondary outcomes

empty

Intervention groups

1

Description
"Intervention Group: Training is done in accordance with BASNEF model as a group. The program is based on the structures BASNEF model within 5 sessions 45-60 minute (2 sessions per week) for 6-4 for each group of 6-4 people with discussion and questions and answers in health centers will be done. In the first and second sessions, on signs, symptoms and lifestyle modification (nutrition, smoking cessation and smoking, stress reduction, weight loss, physical activity, etc.), the importance of regular drug use and side effects will be discussed And the third and fourth sessions of group training on the proper method of blood pressure and control blood pressure need to be allocated. To repeat, educational pamphlet designed to deliver a literate family members to read at home for the patient. According BASNEF model a meeting (Fifth session) attended by influential people on life (including spouse, child or important person in life) and the research team and other personnel for their effects on blood pressure and harmful behaviors will be held . Blood pressure in the intervention group, compliance with all criteria of 7 JNC, before, during (weeks 1, 3 and 5 baseline) and 1 month after intervention by the nurses certified for single-blind (The patient does not know the manner and type of education by the nurse is measured."
Category
Behavior

2

Description
" control group: common training in health centers to receive routine before. In addition, Their blood pressure, compliance with all criteria of 7 JNC, before, during (weeks 1, 3 and 5 baseline) and 1 month after 1 month after completion of the training group, by the nurses certified for single-blind (The patient does not know the manner and type of education by the nurse) is measured."
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Research Center for of Kashan Medical University
Full name of responsible person
Taghadsi Mohsen
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan Medical University
Full name of responsible person
Hamidi Gholamali
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan Medical University
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
Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD -Director of Journal Feyz Department
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
Taghadosi_m@kaums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Full name of responsible person
Taghadosi Mohsen
Position
PhD - Director of Journal Feyz Department
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
Taghadosi_m@kaums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Faculty of Nursing & Midwifery,Kashan University of Medical Sciences
Full name of responsible person
Deldadeh Arani Maliheh
Position
MSc Student of Nursing
Other areas of specialty/work
Street address
Arctic Blvd Ravandi - Kashan University of Medical Sciences
City
Kashan
Postal code
87159/81151
Phone
+98 31 5554 0021
Fax
Email
malihehdeldadeh@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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