Protocol summary

Summary
The present quasi-experimental study intended to determine the impact of self-care education on controlling blood pressure among staff members of Hamedan University of Medical Sciences diagnosed with hypertension and pre-hypertension. A multi-stage sampling technique will be employed. The sample population members enter the study voluntarily and are screened and divided into experimental and control groups. The study population comprises all staff working at Hamedan University of Medical Sciences who are diagnosed with hypertension or pre- hypertension. Eighty patients who meet the inclusion criteria will be recruited from the study population. The inclusion criteria are as follows: people with hypertension or pre- hypertension working at Hamedan University of Medical Sciences; written informed consent for participation; aged 25-55 years, and not taking any medicines to control blood pressure. The exclusion criteria are failure to obtain participant’s consent and absence from educational sessions. Group educational interventions will be conducted by lecturing, having question-and-answer sessions, and providing pamphlets for continuing education. The two-hour educational classes will be held on two days in two consecutive weeks from 8 to 10 or from 10 to 12 a.m. This study will evaluate the impact of education on controlling blood pressure among people with hypertension or pre-hypertension.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016070428788N1
Registration date: 2016-08-31, 1395/06/10
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-08-31, 1395/06/10
Registrant information
Name
fatemeh hosseinabad
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3328 1193
Email address
f.hoseynabadi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2016-09-22, 1395/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education on control hypertension and pre- hypertension
Public title
The effect of self- care education on blood pressure control
Purpose
Other
Inclusion/Exclusion criteria
The present quasi-experimental study intended to determine the impact of self-care education on controlling blood pressure among staff members of Hamedan University of Medical Sciences diagnosed with hypertension and per-hypertension. A multi-stage sampling technique will be employed. The sample population members enter the study voluntarily and are screened and divided into experimental and control groups. The study population comprises all staff working at Hamedan University of Medical Sciences who are diagnosed with hypertension or per-hypertension. Eighty patients who meet the inclusion criteria will be recruited from the study population. The inclusion criteria are as follows: people with hypertension or per-hypertension working at Hamedan University of Medical Sciences; written informed consent for participation; aged 25-55 years, and not taking any medicines to control blood pressure. The exclusion criteria are failure to obtain participant’s consent and absence from educational sessions. Group educational interventions will be conducted by lecturing, having question-and-answer sessions, and providing pamphlets for continuing education. The two-hour educational classes will be held on two days in two consecutive weeks from 8 to 10 or from 10 to 12 a.m. This study will evaluate the impact of education on controlling blood pressure among people with hypertension or per-hypertension.
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamedan University of Medical Sciences
Street address
Iran, Hamedan, Square Martyr Fahmideh, opposite the Mardom park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Approval date
2016-07-03, 1395/04/13
Ethics committee reference number
IR.UMSHA.REC.1395.188

Health conditions studied

1

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

Primary outcomes

1

Description
Blood pressure
Timepoint
Before the intervention, two months after intervention
Method of measurement
mm Hg , using a mercury sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
The present quasi-experimental study starts with obtaining required permissions from the School of Nursing and Midwifery in Hamedan University of Medical Sciences. The researcher will attend Hamedan University of Medical Sciences, explain the research objectives, and call for participation to measure and record blood pressure of all staff members. The recommendations of American Heart Association blood pressure measurements are considered as follows: not consuming caffeinated drinks and not smoking 30 minutes before taking blood pressure; being seated comfortably five minutes before measurement; having both arms supported at heart level and having both legs on the floor; silence during blood pressure measurement; deflating cuff at appropriate speed, and having the barometer at eye level of the observer. Cuff pressure will be filled with air until the pressure reaches 30 millimeter Hg above the level that radial pulse disappears. The mean arterial blood pressure will be assessed using analogue blood pressure (Easy Life, TXJ 30A, ????) and a stethoscope (Anestophon Riester, Germany) whose reliability and validity have already been confirmed. People with prehypertension and hypertension will be screened and those under medications or medical care will be excluded. A multi-stage sampling technique will be employed. The sample society members enter the study voluntarily and 80 samples will be selected after screening. The samples are then divided into experimental and control groups using simple random sampling technique. The research team tries to select samples who match in terms of level of education, age, and medical history. Informed written consents will be obtained from all participants. The data will be collected using a demographic questionnaire and an information data sheet. The experimental group will be informed of the schedule and location of self-care educational classes. The educational intervention will be held in groups through lecturing, having question and answer sessions, and distributing pamphlets for continuing education. People in the experimental group who have basic information about hypertension and control methods will be separated from others to attend different educational classes. The classes will be held for two consecutive weeks on one day in two hours (8-10 or 10-12 a.m.) for both groups (with and without basic information). The first session discusses signs, symptoms, and lifestyle changes and the second session involves discussions on topics such as the importance of regular use of medication, the necessity for regular blood pressure control, standard blood pressure measurement, and side effects of medications. The blood pressure of samples will be recorded two months following the intervention under the same conditions of the screening day.
Category
N/A

2

Description
The staff working at Hamedan University of Medical Sciences will be screened to identity people with hypertension and pre-hypertension. People in the experimental and control groups will be randomly assigned. The control group receives no intervention. The blood-pressure of the intervention and control groups will be measured following two months of the intervention and the results of the two groups will be compared.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Hosseinabad
Street address
Iran, Hamedan ,Square martyr Fahmideh, Opposite the Mardom park
City
Hamedan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mr doctor Shamsaie
Street address
Iran, Hamedan, Square Martyr Fahmideh, opposite the Mardom park ,Hamedan University of Medical Sciences
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Fatemeh Hosseinabad
Position
MSc student
Other areas of specialty/work
Street address
Iran, Hamedan, Square Martyr Fahmideh, opposite the Mardom park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 3838 0320
Fax
Email
f.hoseynabadi@edu.umsha.ac.ir; fhosseinabad2000@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Mohsen Salavati
Position
Clinical faculty
Other areas of specialty/work
Street address
Iran, Hamedan, Square Martyr Fahmideh، opposite the Mardom park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 3838 0320
Fax
Email
salavatimohsen42@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
HamedanUniversity of Medical Sciences
Full name of responsible person
Fatemeh Hosseinabad
Position
MSc student
Other areas of specialty/work
Street address
Iran, Hamedan, Square Martyr Fahmideh, opposite the Mardom park, Hamedan University of Medical Sciences
City
Hamedan
Postal code
Phone
+98 81 3838 0320
Fax
Email
f.hoseynabadi@edu.umsha.ac.ir; fhosseinabad2000@gmail.com
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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