Protocol summary

Study aim
determine of effect of health preservation principles (hefzossehhe) education on quality of life and number of visits of the insured of Iranian health insurance organization
Design
clinical trial with control group, with a parallel group, randomized
Settings and conduct
persons who are insured by Iranian Health Insurance Organization in the State Staff Fund and in accordance with health insurance software have been in upper pillars of Number of visits to outpatient department during the past year will be selected randomly. Individuals are randomly divided into two groups of case and control. the case group will undergo health preservation principles education based on the Health Belief Model.
Participants/Inclusion and exclusion criteria
1- persons who are insured by Iranian Health Insurance Organization in the State Staff Fund 2- 15 to 50 years old age 3- being in 50 to 70 percentile of number of visit during 6 month past 4- Satisfaction of participating in the study
Intervention groups
The intervention group received health preservation principles education based on the Health Belief Model. Educations have been face to face (4 hours), educational pamphlets and training through cyberspace for 6 months. The control group did not receive any education.
Main outcome variables
health preservation principles (hefzossehhe) education, quality of life, number of visits

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20171125037625N1
Registration date: 2019-06-03, 1398/03/13
Registration timing: retrospective

Last update: 2019-06-03, 1398/03/13
Update count: 0
Registration date
2019-06-03, 1398/03/13
Registrant information
Name
Mostafa Abedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 3300 5028
Email address
m.abedi@shahed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-04-21, 1396/02/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-04-21, 1396/02/01
Actual recruitment end date
2017-10-23, 1396/08/01
Trial completion date
2017-10-23, 1396/08/01
Scientific title
Effect of health preservation principles (hefzossehhe) education based on Iranian Medicine on quality of life and number of visits of the insured of Iranian health insurance organization
Public title
Effect of health preservation principles (hefzossehhe) education based on Iranian Medicine on quality of life and number of visits of the insured of Iranian health insurance organization
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
persons who are insured by Iranian Health Insurance Organization in the State Staff Fund 15 to 50 years old being to 50-70 percentile number of visits in six months before the study, according to the statistics of the health insurance organization Satisfaction with participation in the study
Exclusion criteria:
Individuals from the control group who have been effective hygiene education in the course of the study in any way
Age
From 15 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Simple
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahed University of Medical Sciences
Street address
Shahed Univercity, Persian Gulf Freeway
City
Tehran
Province
Tehran
Postal code
33191​18651
Approval date
2018-01-08, 1396/10/18
Ethics committee reference number
IR.Shahed.REC.1396.83

Health conditions studied

1

Description of health condition studied
being in upper pillars of Number of visits to outpatient department
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
number of visits
Timepoint
The first six months of the 1396
Method of measurement
health insurance organization software

2

Description
quality of life
Timepoint
The first six months of the 1396
Method of measurement
sf12 questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: persons who are insured by Iranian Health Insurance Organization in the State Staff Fund and in accordance with health insurance software have been in upper pillars of Number of visits to outpatient department and receive health preservation principles education
Category
Lifestyle

2

Description
Control group: persons who are insured by Iranian Health Insurance Organization in the State Staff Fund and in accordance with health insurance software have been in upper pillars of Number of visits to outpatient department and do not receive health preservation principles education
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center of Traditional Medicine, Shahed University
Full name of responsible person
Farhad Jafari
Street address
No 17, Third Dashtestan Alley, Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1947948614
Phone
+98 21 2288 2596
Email
info@shahed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Dr.Davati
Street address
shahed univercity, Persian Gulf Freeway
City
Tehren
Province
Tehran
Postal code
33191​18651
Phone
+98 21 5522 8800
Email
info@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahed University
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
Shahed University
Full name of responsible person
Mostafa Abedi
Position
MD-PHD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahed Univercity, Persian Gulf Freeway
City
Tehran
Province
Tehran
Postal code
33191​18651
Phone
+98 21 3300 5028
Email
m.abedi@shahed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mostafa Abedi
Position
MD-PHD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahed Univercity, Persian Gulf Freeway
City
Tehran
Province
Tehran
Postal code
33191​18651
Phone
+98 21 3300 5028
Email
m.abedi@shahed.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahed University
Full name of responsible person
Mostafa Abedi
Position
MD-PHD Student
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
Shahed Univercity, Persian Gulf Freeway
City
Tehran
Province
Tehran
Postal code
33191​18651
Phone
+98 21 3300 5028
Email
m.abedi@shahed.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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