Protocol summary

Summary
This study is a randomized controlled research training trial (Randomized Educational Ttrilcluster) is an educational program designed to determine the effect of reducing the amount of salt per day on hypertensive patients sarvestan city and urine sodium content will be retained. In this study, the effects of intervention (education program to reduce salt) on the dependent variable (the amount of residual urine sodium and blood pressure) will be evaluated. The intervention in this study are the type of training, education and the relationship between salt and blood pressure. The training of health workers at first it was a two-day workshop on the relation of blood pressure, salt and hypertension trained, then they will be asked to pass this training into hypertensive patients. This is sometimes due to work and willing participants can take more time on. The first meeting on the sidelines of the issue of the session is designed to give a line of thought will be asked questions. The training sessions of group discussion techniques, training, brainstorming, speech and the media, such as video projectors and interactive training videos and PowerPoint will be used. Training has been transferred to patients by health workers and eight weeks after intervention based on health belief model structures the level of blood pressure and urine will be measured residual sodium.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015051215015N11
Registration date: 2015-10-23, 1394/08/01
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2015-10-23, 1394/08/01
Registrant information
Name
Leila Ghahremani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
ghahramanl@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-12-22, 1393/10/01
Expected recruitment end date
2015-03-30, 1394/01/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the effects of educational interventions by healthy workers at reducing salt intake on blood pressure and urinary sodium remaining hypertensive patients using the health belief model
Public title
Effect of reducing the amount of salt and sodium salt residual urine
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with hypertension, over 30 years, living in the city sarvestan, regardless of the level of education, drug consumption, live in villages and are willing to participate in this study. Exclusion criteria: the unwillingness during the project, refusing to participate in more than two sessions, immigration
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 200
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Shiraz University of Medical Sciences
Street address
Zand St, Central building of Shiraz University of Medical Sciences-Shiraz-Iran
City
shiraz
Postal code
Approval date
2014-11-22, 1393/09/01
Ethics committee reference number
7371

Health conditions studied

1

Description of health condition studied
hypertension
ICD-10 code
I10-I15
ICD-10 code description
Hypertensive diseases

Primary outcomes

1

Description
The remaining sodium urine
Timepoint
8 weeks
Method of measurement
The remaining sodium urine test

2

Description
Blood pressure
Timepoint
8 weeks
Method of measurement
Mercury sphygmomanometer devices

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group a training program on salt intake and its relation to blood pressure will be held in four sessions. .
Category
Behavior

2

Description
The group held a training program for cancer patients.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Home Health of Health center city sarvestan
Full name of responsible person
kaveh ghodraty
Street address
Health Education Department, School of Health, Shiraz University of Medical Sciences
City
shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
dr poost forosh
Street address
Zand St, Central building of Shiraz University of Medical Sciences
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
kaveh ghodraty
Position
MSc student of Health Education
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, School of Public Health, Department of Health Education
City
Shiraz
Postal code
Phone
+98 37846981
Fax
Email
kaveh1316@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahremani
Position
Ph.D
Other areas of specialty/work
Street address
Shiraz University of Medical Sciences, School of Public Health, Department of Health Education-shiraz-iran
City
Shiraz
Postal code
Phone
+98 71 3725 1001
Fax
Email
ghahramanl@sums.as.irkaveh1316@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
kaveh ghodraty
Position
MSc student of Health Education
Other areas of specialty/work
Street address
Health Education department, School of Health, Shiraz University of Medical Sciences
City
Postal code
Phone
+98 71 3784 6981
Fax
Email
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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