The effect of self-care education on the control of hypertension in patients with hypertension
Design
Clinical trials with control group, with parallel and randomized groups
Settings and conduct
Patients with hypertension who referred to Isfahan health center who have hypertension records in the selected health care center were selected by random sampling method. 80 patients were selected. Then, the units were divided into two groups of 40 intervention and control groups, and the intervention group received a basic medical education at Isfahan Health Center No.1.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study.
Age 30 to 60 years
Know about your blood pressure for at least 2 years.
Have a case at the health center.
Non-Inclusion criteria:
Having severe mental illness requiring drug use.
Having a debilitating physical disorder.
Intervention groups
After determining the control group and the intervention, self-efficacy education was conducted in 5 sessions of 90 minutes. Trainings were given to the experimental group by a trained health care provider supervised by the researcher. Educational interventions were used for group training, group discussion, and facial education. Training sessions focused on a set of self-efficacy strategies including success in performance, substitution experiences, verbal encouragement, physiological / emotional excitement. The control group did not have any training, but after the completion of the study, a briefing session was considered for the control group. Blood pressure was calibrated before and three months after training with mercuric pressure gauge and proper and standard principles for both groups were performed. Sherr and Cohen questionnaires were completed before and after the intervention by the patients.
Main outcome variables
Self-efficacy; high blood pressure control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171230038142N7
Registration date:2019-03-06, 1397/12/15
Registration timing:retrospective
Last update:2019-03-06, 1397/12/15
Update count:0
Registration date
2019-03-06, 1397/12/15
Registrant information
Name
Khosro Tavakol
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 9134
Email address
tavakol@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-07, 1397/07/15
Expected recruitment end date
2018-12-21, 1397/09/30
Actual recruitment start date
2018-10-07, 1397/07/15
Actual recruitment end date
2018-12-30, 1397/10/09
Trial completion date
2019-03-02, 1397/12/11
Scientific title
The effect of self-care education on the control of hypertension in patients with hypertension
Public title
Investigating the effect of self-directed learning on blood pressure control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Satisfaction to participate in the study
Age 30 to 60 years
Know about your blood pressure for at least 2 years.
Have a case at the health center.
Exclusion criteria:
Having severe mental illness requiring drug use.
Having a debilitating physical disorder.
Age
From 30 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method was multi-stage. So, in the first stage, a network was selected randomly from the health networks of the cities of Isfahan province by drawing lots. In the second step, a checklist was selected from the total number of health centers in the city. Again, completely randomized and 50% of the centers were selected using the lottery method. In the last stage, according to the sample size and case records, 80 patients in the center of the file were extracted and randomly divided into two groups of control and intervention. Individuals' selection and random allocation of subjects were divided into intervention and control groups using SPSS software.
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 Isfahan University of Medical Sciences
Street address
Hezar Jarib Ave., Isfahan University of Medical Sciences.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2018-10-03, 1397/07/11
Ethics committee reference number
IR.MUI.MED.REC.1397.056
Health conditions studied
1
Description of health condition studied
High blood pressure
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
self-efficacy
Timepoint
Before and three months after the last day of the intervention sessions
Method of measurement
The Sherer general self-efficacy questionnaire, which has 17 terms, is based on the 5-degree Likert scale (I completely disagree = 1, I totally agree = 5). The highest score of the questionnaire is 85 and the lowest score is 17.
2
Description
Perceived Stress
Timepoint
Before and three months after the last day of the intervention sessions
Method of measurement
Cohen's Perceived Stress Questionnaire, which has 14 questions in the 5-degree Likert scale (none = 5 to very much = 1), questions 4, 5, 6, 7, 8, 9, 10, 13 are scored in reverse order. .
3
Description
blood pressure
Timepoint
Before and three months after the last day of the intervention sessions
Method of measurement
The mercuric pressure gauge is calibrated and adhered to the correct principles and standard blood pressure measurement.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group had self-efficacy training in 5 sessions of 90 minutes. The training was given to the intervention group by a trained health care provider supervised by the researcher. Educational interventions were used for group training, group discussion, and facial education. Training sessions focused on a set of self-efficacy strategies including success in performance, substitution experiences, verbal encouragement, physiological / emotional excitement. Blood pressure was calibrated before the training and three months after training, and the mercury pressure gauge was calibrated and strict and standard principles were followed. Sherr and Cohen questionnaires were completed before and after the intervention by the patients.
Category
Treatment - Other
2
Description
Control group: No specific training. Just because of ethics and fairness, the researcher held a training session for the control group upon completion of the study. Blood pressure was calibrated before the training and three months after training, and the mercury pressure gauge was calibrated and strict and standard principles were followed. Sherr and Cohen questionnaires were completed with the intervention group before and after the intervention by the patients.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Isfahan Province Health Centers.
Full name of responsible person
Reza Roozbehani
Street address
Hezar Jarib Ave. Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
rerouzbah@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Ziba Farajzadegan
Street address
Vice-Chancellor for Research of School of Medicine,. Isfahan University of Medical Sciences,. Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 8597
Email
dean@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Reza Roozbehani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences. Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 6888 0048
Email
rerouzbah@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Roozbehani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences. Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
rerouzbah@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Reza Roozbehani
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Isfahan University of Medical Sciences. Hezar Jarib Ave.
City
Isfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31366880048
Email
rerouzbah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole information is unpublished after being unrecognizable and publishing the results.
When the data will become available and for how long
Information is available two years after the publication of the article.
To whom data/document is available
Assistants and specialists in social medicine, psychology and psychiatry
Under which criteria data/document could be used
To compare the information and the results with another similar study in another city or city of Isfahan.
From where data/document is obtainable
Deputy of Research and Student Deputy of Isfahan University of Medical Sciences
What processes are involved for a request to access data/document
Send an e-mail to rerouzbah@gmail.com and get permission from the Research Vice-Dean and Student Deputy of Isfahan University of Medical Sciences.