Overall objective: To determine the effect of a behavioral cognitive intervention on self-care behaviors and blood pressure control in patients with primary hypertension
Partial Objectives:
1- Determining and comparing the average score of awareness, self-efficacy, outcome expectations, evaluation of outcome expectations and self-regulation of high blood pressure self-care behaviors in the control and intervention group before and one month after the educational intervention
2- Determining and comparing the average scores of recommended self-care behaviors and its areas (adherence to treatment, nutritional behaviors and blood pressure control) before and one month after the educational intervention between the two groups.
3- Determining and comparing the mean systolic and diastolic blood pressure measured before and one month after the educational intervention between the two groups.
Design
A clinical trial with a control group (factorial), one-way blind, randomized (Lottery), on 100 patients.
Settings and conduct
The clinical trial study will be conducted with a randomized controlled group on patients over 30 years of age with primary hypertension in Darcheh 1 Health Center in Isfahan with cognitive-behavioral intervention on the test group. The study will be conducted without informing the two groups of assignment to the test or control group and as a blind side
Participants/Inclusion and exclusion criteria
1- A person with primary hypertension
2- Age over 30 years old
3- Tendency to participate in research and complete the consent form
Intervention groups
The Cognitive Behavioral Educational Intervention Program based on Cognitive Behavioral Theory and Self-Regulation will be held during 6 training sessions for 1 month for test group participants.
Main outcome variables
Improving self-care behaviors and controlling blood pressure in patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200621047870N1
Registration date:2020-07-04, 1399/04/14
Registration timing:retrospective
Last update:2020-07-04, 1399/04/14
Update count:0
Registration date
2020-07-04, 1399/04/14
Registrant information
Name
Elham Ebrahimi dorcheh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3375 5127
Email address
elhamebrahimi1344@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-19, 1398/06/28
Expected recruitment end date
2019-10-12, 1398/07/20
Actual recruitment start date
2019-10-17, 1398/07/25
Actual recruitment end date
2019-12-22, 1398/10/01
Trial completion date
2019-12-22, 1398/10/01
Scientific title
The effect of cognitive behavioral intervention on selfcare behaviors and blood pressure control in patients with primary high blood pressure
Public title
Investigating the effect of educational intervention on self-care behaviors and blood pressure control
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A person with primary hypertension
Age over 30 years old
Exclusion criteria:
Not wanting to participate in the study and not completing the consent form
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Actual sample size reached:
84
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sampling is a lottery. (Writing the names of the patients on the card and placing them in a box and combining and mixing the cards in the box and then randomly selecting them from inside the box.)
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants in the study included patients with primary hypertension who will randomly assign to the experimental and control groups by lottery. During the course of research and communication with patients (obtaining consent, completing questionnaires and collecting data before and after the intervention, performing the intervention) no information will be given to the patient about his or her assignment to the test and control group.
Also, any connection between the test and control group will be prevented. It is worth mentioning that in order to observe the scientific and moral standards after the intervention, self-care training classes will be held for the control group.
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
Isfahan, Hezar Jarib St., Isfahan University of Medical Sciences
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Approval date
2019-09-16, 1398/06/25
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.360
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
Blood pressure level
Timepoint
Before the educational intervention and one month after the educational intervention
Method of measurement
Mercury sphygmomanometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In this study, in addition to receiving conventional care for patients with hypertension, the intervention group will participate in cognitive-behavioral training classes based on behavioral cognitive theory and self-regulation related to blood pressure self-care behaviors. The training program will include 6 sessions, each lasting 2 hours during a month by the researcher.The educational content was determined and adjusted based on the reliable source of the Ministry of Health.The objectives of each session include: the first session : goals setting and planning for action in promoting self-care behaviors، second session :awareness of the disease، fifth session : self-regulation and the promotion of self-care behaviors, and the sixth session will focus on self-assessment and response to self-behavior.The trainings will be held in groups using a combination of teaching methods of lecturing, question and answer, brainstorming, group discussion and role-playing. During training classes, media such as pamphlets, books, posters, videos and educational photos are used to increase learning.Also, the checklist designed by the researcher related to recording self-care behaviors will be completed by the intervention group.
Category
Other
2
Description
Control group: The control group will not receive any training intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dorcheh Comprehensive Health Center 1
Full name of responsible person
Elham ebrahimi dorcheh
Street address
Isfahan, Dorcheh, Basij Street
City
Esfahan
Province
Isfehan
Postal code
84316-36631
Phone
+98 31 3376 8797
Email
elhamebrahimi1344@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr. Shaghayegh Haghjoo Javanmard
Street address
Isfahan, Shiraz Gate, Hezar Jarib St., Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 0048
Fax
+98 31 3668 2006
Email
jazb@mui.ac.ir
Web page address
http://www.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
Elham ebrahimi dorcheh
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
elhamebrahimi1344@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham Ebrahimi dorcheh
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Fax
Email
elhamebrahimi1344@Gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Elham ebrahimi dorcheh
Position
MSC student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Isfahan University of Medical Sciences, Hezar Jarib St.
City
Esfahan
Province
Isfehan
Postal code
81746-73461
Phone
+98 31 3668 0048
Email
elhamebrahimi1344@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
All potential data can be shared after people have not been identified
When the data will become available and for how long
Start access after printing results
To whom data/document is available
All people working in the academic, scientific and industrial sectors are able to receive data
Under which criteria data/document could be used
1- Using information to conduct scientific and research studies
2- Not changing the information and observing the moral standards
From where data/document is obtainable
1- Researchers and authors of research projects
2- Vice Chancellor for Research of the University (Isfahan University of Medical Sciences)
* Communication routes for executives and authors of research projects:
1- Ms. Elham Ebrahimi Dorcheh:
Address: No. 26, Safa Alley, Imam St., Dorcheh, Isfahan
Contact Number: 09133764592
Email Address: elhamebrahimi1344@gmail.com
2- Dr. Ahmad Ali Eslami
Address: Isfahan, Hezar Jarib St., Isfahan University of Medical Sciences, School of Health, Department of Health Education
Contact Number: 09124214268
Email Address: eslamiaa@gmail.com
What processes are involved for a request to access data/document
After contacting the project executors and reviewing the applicant's scientific and ethical competence, the information will be provided to her as soon as possible.