Evaluating efficacy of pharmacist based self-monitoring of blood pressure in patients with hypertension in comparison with conventional method by physician.
Design
Randomized, not blinded, parallel group, controlled clinical trial between September 2016 and June 2017
Settings and conduct
The present study was carried out at cardiovascular clinic of Shahid-Madani hospital. The sample size was 150 people who visited within 6 months.
Participants/Inclusion and exclusion criteria
Patients with hypertension and over 18 years of age who signed the consent form were enrolled in the study.
Patients with secondary hypertension, pregnant women, nursing mothers, and patients who cannot measure his/her blood pressure were excluded from the study.
Intervention groups
In intervention group, patients were measured their blood pressure by using digital blood pressure machine which were calibrated by the pressure gauge of the clinic. All patients were trained by a clinical pharmacist to measure their blood pressure and adjust their medications based on the protocol.The method used was that if the blood pressure of patients without any background problem was higher than 90/140 mmHg or in patients with background problems such as diabetes and ischemic heart disease was higher than 80/130 mmHg, they increase the dosage of their drugs.If they had beta-blockers in their treatment regimen, they increase its dose to control the pacing of the heart to a range of 70-60 ppm.In the case of a chest pain, they were allowed to use sublingual TNG up to 3 doses in 5 minutes intervals to improve the symptoms.If their systolic blood pressure was higher than 180 mm Hg, they should use sublingual captopril.
In control group, conventional method by cardiologist was used to manage patients' blood pressure
Main outcome variables
Comparing blood pressure of patients between intervention and control groups.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111206008307N29
Registration date:2018-08-08, 1397/05/17
Registration timing:retrospective
Last update:2018-08-08, 1397/05/17
Update count:0
Registration date
2018-08-08, 1397/05/17
Registrant information
Name
Taher Entezari-Maleki
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
tentezarimaleki@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-21, 1395/06/31
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
2016-09-21, 1395/06/31
Actual recruitment end date
2017-06-14, 1396/03/24
Trial completion date
empty
Scientific title
Pharmacist led self-monitoring of blood pressure verus conventional management in patients with hypertension
Public title
Pharmacist led self-monitoring of blood pressure verus conventional management
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
outpatients with primary hypertension
patients with 18 years old and over
consented patients
Exclusion criteria:
secondary hypertension
pregnancy
nursing mothers
liver failure
kidney failure
heart failure
anti-hypertensive drugs contraindications
patients who cannot measure his/her blood pressure
blind people
lack of required qualifications for satisfaction
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
150
Actual sample size reached:
126
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization was done using computer systematic randomization by an independent person.
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
Ethic Committee of Tabriz Univercity of Medical Science
Street address
Reasearch and Technology Deputy, Tabriz University of Medical Science, Golgasht Street, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2016-08-11, 1395/05/21
Ethics committee reference number
TBZMED.REC.1394.1135
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
blood pressure
Timepoint
before intervention and 4,8 , 12 weeks after intervention
Method of measurement
sphygmomonometer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients were measured their blood pressure by using digital blood pressure machine which were calibrated by the pressure gauge of the clinic. All patients were trained by a clinical pharmacist to measure their blood pressure and adjust their medications based on the protocol.The method used was that if the blood pressure of patients without any background problem was higher than 90/140 mmHg or in patients with background problems such as diabetes and ischemic heart disease was higher than 80/130 mmHg, they increase the dosage of their drugs.If they had beta-blockers in their treatment regimen, they increase its dose to control the pacing of the heart to a range of 70-60 ppm.In the case of a chest pain, they were allowed to use sublingual TNG up to 3 doses in 5 minutes intervals to improve the symptoms.If their systolic blood pressure was higher than 180 mm Hg, they should use sublingual captopril.
Category
Treatment - Other
2
Description
Control group: Conventional method was used to control blood pressure by a cardiologist.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinics of Shahid Madani Hospital
Full name of responsible person
Taher Entezari-Maleki
Street address
Clininc of Shahid Madani Hospital,Golgasht Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3334 4798
Email
tentezari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolghacem Joiban
Street address
Tabriz Universit of Medical Sciences, Golgasht Street, Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7310
Fax
+98 41 3334 4280
Email
ajouyban@hotmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-maleki
Position
Assistant professor/ Clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz medical university,Golgasht street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3337 2250
Fax
+98 41 3334 4798
Email
tentezari@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher Entezari-Maleki
Position
Assistant professor/ Clinical pharmacist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz medical university ,Golgasht street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51666414766
Phone
+98 41 3337 2250
Fax
+98 41 3334 4798
Email
tentezari@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Taher entezar maleki
Position
Associated Professor of clinical pharmacy
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
Pharmacy faculty of tabriz medical university ,Golgasht street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
51666414766
Phone
+98 41 3337 2250
Fax
+98 41 3334 4798
Email
tentezari@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
No - There is not 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