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The effect of education on Mean blood pressure and drug adherence in patients with hypertensive crisis

Protocol summary

Study aim
The effect of education on mean blood pressure and drug adherence is determined in patients with hypertensive crisis.
Design
This is an interventional study of the type of educational trial that will be conducted on 148 patients with blood pressure crisis who refer to the emergency department of Shahid Modares Teaching Hospital and Social Security Hospital and clinics in Saveh city.
Settings and conduct
Based on random block allocation, patients are placed in one of the intervention (training) or control (routine) groups. Patients are trained in 2 sessions for 20-25 minutes in each session. . At the end of the second, third and fourth weeks at regular intervals, the patient's blood pressure will be taken and recorded again by the administrator and patients' questions will be answered. Patients in the control group will be routinely trained.
Participants/Inclusion and exclusion criteria
Patients are between 18-60 years old.Be able to take care of yourself and take medication Lack of cognitive and psychological problems According to the patient, the patient should not have secondary hypertension. Be literate and speak Persian.Do not have a heart attack, stroke, transient ischemic attack, kidney disorders, heart failure, or be pregnant.
Intervention groups
Patients will be trained in 2 sessions in the first week after the crisis and each session lasts 20-25 minutes. The content of the training related to the definition of normal blood pressure, definition of hypertension, definition of hypertensive crisis, disease causes, risk factors, symptoms, self-care behaviors in hypertension, including diet, proper exercise, medication. At the end, an educational booklet is provided to the patient and his companion.
Main outcome variables
Average blood pressure; drug adherence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220316054313N1
Registration date: 2022-08-31, 1401/06/09
Registration timing: registered_while_recruiting

Last update: 2022-08-31, 1401/06/09
Update count: 0
Registration date
2022-08-31, 1401/06/09
Registrant information
Name
nasrin amerehgoli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 4246 9304
Email address
n.amerehgoli@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2022-11-22, 1401/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of education on Mean blood pressure and drug adherence in patients with hypertensive crisis
Public title
The effect of education on Mean blood pressure and drug adherence in patients with hypertensive crisis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be between 18-60 years old Be able to take care of yourself and take medication Lack of cognitive and psychological problems According to the patient, the patient should not have secondary hypertension. Be literate and speak Persian. Do not have a heart attack, stroke, transient ischemic attack, kidney disorders, heart failure, or be pregnant. Systolic or diastolic blood pressure should be 120/180 or more No financial problems to prepare and use medicine based on the patient's statement. Do not take NSAIDs, glucocorticoids, antidepressants, caffeine, nicotine and licorice Lack of resistance to treatment in a person with high blood pressure
Exclusion criteria:
Patients who die after training Patients who develop cardiopulmonary arrest after training or need intervention methods (angiography or angioplasty), or surgery (heart, brain ...). Existence of resistance to treatment Administration of any of the NSAIDs, glucocorticoids, antidepressants, caffeine, nicotine and licorice during the study
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 148
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly allocated into intervention and control groups. Blocking is used in order to balance the number of samples allocated to each of the studied groups. The size of all the blocks is equal and in this experiment we will have two groups of 4 blocks (including 2 people in the intervention group and 2 people in the control group). R statistical software is used to prepare the randomization list. Before the start of the study, the randomization list was prepared by the professor of statistics and given to the main researcher. Group A and B were written in the envelopes, respectively, and the researcher opened the envelopes during sampling and as soon as each patient entered. will assign the patient.
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 Arak University of Medical Sciences
Street address
Khatam Al-Anbia University Complex., Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3914334911
Approval date
2022-05-22, 1401/03/01
Ethics committee reference number
IR.ARAKMU.REC.1401.066

Health conditions studied

1

Description of health condition studied
Hypertensive crisis
ICD-10 code
I15.8
ICD-10 code description
Other secondary hypertension

Primary outcomes

1

Description
Blood pressure
Timepoint
End of the second, third and fourth week
Method of measurement
Mm Hg using a sphygmomanometer

2

Description
Drug adherence
Timepoint
One month after the intervention
Method of measurement
Girerd Drug Adherence Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For patients in the intervention group, in the first week after the hypertensive crisis, 2 training sessions for 20-25 minutes will be performed in groups of up to 8 people.The patient's mobile number is taken for follow-up. During the study, the patient is called once a week (4 phone calls during the study).In this call, while re-emphasizing the importance of controlling blood pressure and reminding important issues, patients' questions are answered.At the end of the second, third and fourth weeks, patients' blood pressure will be measured and recorded using a mercury sphygmomanometer.
Category
Lifestyle

2

Description
Control group: These patients, like other patients (in the intervention group), will receive the necessary treatments based on the prescription of the treating physician and will receive training that is done routinely by them. At this stage, these patients do not receive the training given by the facilitator to the patients in the intervention group. The blood pressure of these patients is taken and recorded at the end of the second, third and fourth weeks. Will be registered.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Medical centers under the auspices of Saveh School of Medical Sciences
Full name of responsible person
Nasrin Amerehgoli
Street address
Modares Hospital., Modares Blvd., Motahhari St., Saveh Town
City
Saveh
Province
Markazi
Postal code
3915617157
Phone
+98 86 4222 2042
Fax
+98 86 4222 3321
Email
Namerehgoli72@gmail.com

2

Recruitment center
Name of recruitment center
Saveh Social Security Hospital
Full name of responsible person
Nasrin Amerehgoli
Street address
Chamran Hospital., Old Tehran Ave., Saveh Town
City
Saveh
Province
Markazi
Postal code
3817793163
Phone
+98 86 4242 2441
Fax
+98 86 4242 2361
Email
Namerehgoli72@gmail.com
Web page address
https://chamran.tamin.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr. Alireza Kamali
Street address
Payambar Azam University Complex., Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Email
Namerehgoli72@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Nasrin Amerehgoli
Position
Master student of critical care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Payambar Azam University Complex., Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Email
Namerehgoli72@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Kourosh Rezaei
Position
Master of nursing
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Payambar Azam University Complex., Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Email
k.rezaei@arakmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nasrin Amerehgoli
Position
Operating room expert
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Payambar Azam University Complex., Basij Sq., Sardasht Town
City
Arak
Province
Markazi
Postal code
3914334911
Phone
+98 86 3417 3505
Fax
+98 86 4222 3321
Email
Namerehgoli72@gmail.com
Web page address
https://www.arakmu.ac.ir/fa

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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