Protocol summary

Summary
Overall Objectives: Determining the effect of self-help groups on self-care behaviors of women aged 30-60 years old. This study is done in two stages. Cross-sectional study to assess the reliability and validity of the questionnaire - An educational interventional study on 100 hypertensive patients (in each group of 50 people). This study is carried out through the following steps: - Selection of samples - Blood pressure measurement and index Body mass of the subjects - pre-test by distributing the questionnaire and studying the motivation, self-efficacy and self-care behavior of hypertensive patients before intervention. Self-care curriculum package based on pre-defined needs assessment - Provide self care curriculum to two intervention and control groups - Formation of self-help groups based on the instructions for forming self-help groups in groups of 10 and steering groups in Organizing self-care sessions once a week - Organizing training sessions for group leaders - Involving researchers in self-help group sessions as facilitators for four sessions and then indirectly through leaders - Performing a post-test and redistributing a three month questionnaire. Next, the criteria for entering the study are: - proven blood pressure disease - having records in the health database Exclusion criteria: side effects of blood pressure ; pregnancy blood pressure

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017062634769N1
Registration date: 2017-08-20, 1396/05/29
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-08-20, 1396/05/29
Registrant information
Name
Fateme Safari
Name of organization / entity
Arak University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34377031
Email address
f.safari@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2017-06-22, 1396/04/01
Expected recruitment end date
2017-07-16, 1396/04/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Self-help Groups on Self-care Behaviors of Women Aged 30-35
Public title
High Blood Pressure Self-care
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:( Proven blood pressure disease; Having a case at the health center) Exclusion criteria: (side effects of blood pressure ; pregnancy blood pressure)
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Governmental

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Arak University of Medical Sciences, Basij Square, Sardasht، Arak
City
Arak
Postal code
Approval date
2017-03-06, 1395/12/16
Ethics committee reference number
IR.ARAKMU.1395.447

Health conditions studied

1

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

Primary outcomes

1

Description
Self-care is blood pressure
Timepoint
3 Month
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Increase self-care
Timepoint
3 month
Method of measurement
Questionnaire

Intervention groups

1

Description
Control group: only booklet
Category
Behavior

2

Description
Intervention group:Booklet and self-help group
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shazand Health Center
Full name of responsible person
Fateme Safari
Street address
Health Center, Shahied Motahari Hospita Street, Shazand
City
Shazand

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research,Arak University of Medical Sciences
Full name of responsible person
Fateme Safari
Street address
Arak University of Medical Sciences, Basij Square, Sardasht، Arak
City
Arak
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research,Arak 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
Arak University of Medical Sciences
Full name of responsible person
Dr. Mohammad Rafiee
Position
Student
Other areas of specialty/work
Street address
Arak University of Medical Sciences, Basij Square, Sardasht، Arak
City
Arak
Postal code
Phone
+98 86 3437 7031
Fax
Email
tahavatasnim@gmail.com ; F.Safari@arakmu.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Nasrin Roozbehani
Position
PHD/ Associate Professor
Other areas of specialty/work
Street address
Mostafa Khomeini-Koi Golestan, School of Public Health
City
Arak
Postal code
Phone
+98 86 3437 7031
Fax
Email
roozbahani7281@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Fateme Safari
Position
Masters Student
Other areas of specialty/work
Street address
Unit 10, Block A, Razvand Complex, Imam Khomeini Street, Arak
City
Arak
Postal code
Phone
+98 86 3437 7031
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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