Protocol summary

Study aim
Determining the Effect of Intervention Based on the Levental’s Self-regulation model on illness perception and Lifestyle of Patients with Hypertension
Design
The study was a clinical trial with control group, with parallel groups, 90 patients with hypertension randomly divided into two groups of control and test.
Settings and conduct
90 patients with primary hypertension type 1 and 2 are assigned randomly into two groups of 45 intervention and control groups.The educational intervention is carried out at the Shahid Dastgheib Health Center in Yasuj, Iran. the data collection tool was a questionnaire for perceived disease and lifestyle that was completed before and 3 months after intervention by the patients
Participants/Inclusion and exclusion criteria
Inclusion criteria: Early diagnosis of high blood pressure Early diagnosis of hypertension with expert opinion, aged 18 to 65 years, at least six months of hypertension diagnosis, having a willingness to participate in the study, gaining a lifestyle score of 105 or less, no psychological intervention, or counseling about Hypertension, hypertension, hypertension, stage 1 or 2 Exit criteria: Cancellation of the continuation of the study whenever the patient wishes, the occurrence of new illness or critical complications of high blood pressure such as heart and brain attack and dialysis
Intervention groups
Intervention group undergoes 5 sessions of training in a group based on the sub-scales of identity, cause, duration, outcome, control and treatment, coherence of the disease, emotional manifestations of illness and lifestyle education in person.The control group is not subject to any intervention.
Main outcome variables
illness Perception ؛ lifestyle

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20141222020401N6
Registration date: 2019-05-08, 1398/02/18
Registration timing: registered_while_recruiting

Last update: 2019-05-08, 1398/02/18
Update count: 0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Nazafarin Hosseini
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 5144
Email address
hosseini.nazafarin@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-08, 1398/01/19
Expected recruitment end date
2019-06-08, 1398/03/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education based on Levental’s self regulation model on illness perception and lifestyle in patients with hypertension .
Public title
The effect of education based on Levental’s self regulation model in patients with hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Early diagnosis of high blood pressure Early diagnosis of hypertension with expert opinion aged 18 to 65 years at least six months of hypertension diagnosis having a willingness to participate in the study gaining a lifestyle score of 105 or less no psychological intervention, or counseling about Hypertension hypertension, stage 1 or 2
Exclusion criteria:
Being afflicted with critical complications of high blood pressure such as heart and brain and doing dialysis
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: 90
Randomization (investigator's opinion)
Randomized
Randomization description
A random block method is used. with the aim of equalizing the number of people in the intervention and control group, factor 2 is used by factoring law And 24 blocks of 4 persons that differ in their ordering so that in each block two samples of the control and intervention group and in the form of a draw, one of the blocks is selected. Sampling is continued until 45 patients in each group
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 yasuj University of Medical Sciences
Street address
Assistance of Research and Technology of the University , Yasouj University of Medical Sciences , Shahid Motahari Blvd., Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Approval date
2019-03-01, 1397/12/10
Ethics committee reference number
IR.YUMS.REC.1397.147

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
illness perception
Timepoint
Before and 3 months after the intervention
Method of measurement
IPQ-R questionnaire(illness perception questionnaire revised)

2

Description
lifestyle
Timepoint
Before and 3 months after the intervention
Method of measurement
LSQ Life Style Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 45 people undergo a 5-sessions 60-minutes training course on the perception of illness and lifestyle
Category
Prevention

2

Description
Control group: 45 patients in group control do not receive educational
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Dastgheib Yasuj Health Center
Full name of responsible person
Nazafarin Hosseini
Street address
nursing school , Dr. Shahid Jalil street, Yasouj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
hosseinichenar@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Vice-chancellor of Research, Dr. Hossein Mari Oryad
Street address
Vice chancellor of Research and Technology, Yasuj University of Medical Sciences, Shahid Motahari Blvd., Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591741417
Phone
+98 74 3334 6078
Email
oryadhsn@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yasouj 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
Yasouj University of Medical Sciences
Full name of responsible person
Dr. Nazafarin Hosseini
Position
Ph.D. Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Zaynab nursing school . Dr. shajid jalil Street, Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 33235140
Email
hosseinichenar@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Dr.Nazafarin Hosseini
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Hazrat Zaynab Nursing School. Dr. shajid jalil Street, Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
hosseinichenar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Yasouj University of Medical Sciences
Full name of responsible person
Fatemeh Saranjam
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Hazrat Zaynab Nursing School . Dr. shahid jalil Street, Yasuj , Iran
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591994799
Phone
+98 74 3323 5140
Email
fatemeh.saranjam@yums.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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