Protocol summary

Study aim
Determining the effect of self-care behaviors training on blood pressure control through home visits in middle aged people with primary hypertension
Design
'v,The study groups included middle-aged people with hypertension who had health records at the health centers of southern Tehran. The research sample consisted of 110 subjects who were selected by simple random sampling. And then they were randomly assigned to two groups of control and intervention.
Settings and conduct
The research environment was the center of comprehensive health services in southern Tehran, providing comprehensive educational, care and medical services to covered individuals.
Participants/Inclusion and exclusion criteria
1- Having reading and writing skills and being able to communicate effectively 2- Age range 30-59 years 3. The definitive diagnosis of the disease and the results of confirmed diagnostic tests 4- Lack of psychological problems with self-declaration of people and approval 1- There is a motor defect that does not have self-care ability. 2. The disease becomes acute and severe. 3. Immigration from the region 4. Do not wish to continue cooperation
Intervention groups
A total of 110 middle-aged patients with hypertension living in southern Tehran were eligible for inclusion in this study.
Main outcome variables
Systolic and diastolic Hypertension, Administration of prescription drugs, Low salt diet, Physical activity, Weight management, Smoking

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190623043985N1
Registration date: 2019-06-30, 1398/04/09
Registration timing: retrospective

Last update: 2019-06-30, 1398/04/09
Update count: 0
Registration date
2019-06-30, 1398/04/09
Registrant information
Name
sara hazratigonbad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6623 0018
Email address
sarahazrati12123@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2018-11-21, 1397/08/30
Actual recruitment start date
2018-09-22, 1397/06/31
Actual recruitment end date
2018-11-21, 1397/08/30
Trial completion date
2018-11-21, 1397/08/30
Scientific title
The effect of Self-care education through home-visits on blood pressure control and self-care behaviors among middle aged people with primary hypertension
Public title
The effect of Self-care education through home-visits on blood pressure control and self-care behaviors among middle aged people with primary hypertension
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
.Having reading and writing skills and being able to communicate effectively Age range of 30-59 years . Definitive diagnosis of disease and results of confirmed diagnostic tests . No psychological problems with self-declaration of individuals and approval of the health center
Exclusion criteria:
1- There is a motor defect that does not have self-care ability. 2. The disease becomes acute and severe .3. Immigration from the region 4. Do not wish to continue cooperation.
Age
From 30 years old to 59 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 110
Actual sample size reached: 110
Randomization (investigator's opinion)
Randomized
Randomization description
About 156 people were eligible to participate in the study. First, all of these people were contacted. Some people were not accountable, and some did not go to the health center, and some did not want to cooperate. Eventually, the number of people referred to about 138 people. Then, using a simple random sampling method, each person received an identifier and selected 18 draws in a draw. Selected identifiers were excluded from the study and the remaining identifiers were selected as research samples. Approximately 110 individuals were selected. Subsequently, for random assignment of samples to two groups of intervention and control, each study sample was assigned an identifier and according to the table Random numbers were divided into two groups of test and control. In this method, first, according to the sample size (110 people), two columns were included in the random numbers table, then a number as the starting point was randomly selected and proceeded based on it, and the numbers were less than the sample size selected as the intervention group And the remaining numbers were selected as the control 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 tehran University of Medical Sciences
Street address
no7,parnian ave, rajai blvd, shahrak valiasr
City
tehran
Province
Tehran
Postal code
13766-16553
Approval date
2018-07-21, 1397/04/30
Ethics committee reference number
ir.tums.fnm.rec.1397.064

Health conditions studied

1

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

Primary outcomes

1

Description
Regular blood pressure control,the measure this blood pressure variable, the subjects were measured before the intervention and one month after the intervention. Also, to check the regular blood pressure control, the frequency of blood pressure measurements during the week was measured by a questionnaire before intervention and one month after intervention.
Timepoint
ONE months after the end of the intervention
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: hypertension disease.In the intervention group, for 3-5 sessions during two months of intervention, self-care behaviors included low salt diet, drug compliance, regular physical activity, non-smoking, weight management and regular blood pressure measurements provided during the home visit program Is . They also receive routine care for health centers.
Category
Lifestyle

2

Description
Control group: The usual care is provided by health centers.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Health Center ofKhakbaz
Full name of responsible person
Dr.Abniki
Street address
No159,Mobl Mahdi Ave.shandiz Ave,Eastern Yaftabad
City
Tehran
Province
Tehran
Postal code
1361813311
Phone
+98 21 6623 9074
Email
Sarahazrati12123@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Shahzad Pashaeipoor
Street address
Tehran nuring university, East Nosrat Ave, Tohid
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6693 7120
Email
Sarahazrati12123@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sara Hazrati Gonbad
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No7,Parnian Ave,Rajai Blvd.Shahrak Valiasr
City
Tehran
Province
Tehran
Postal code
13766-16553
Phone
+98 21 6623 0018
Email
Sarahazrati12123@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Hazrati Gonbad
Position
Masters Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No7,Parnian Ave, Rajaei Blvd, Shahrak Valiasr
City
Tehran
Province
Tehran
Postal code
13766-16553
Phone
+98 21 6623 0018
Email
Sarahazrati12123@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Hazrati Gonbad
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No7, Parnian Ave, Rajaei,Blvd, Shahrak Valiasr
City
Tehran
Province
Tehran
Postal code
13766-16553
Phone
+98 21 6623 0018
Email
Sarahazrati12123@gmail.com

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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