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Impacts of pharmacist's medication care in type 2 diabetic to prevent cardiovascular disease

Protocol summary

Study aim
The effects of pharmacist care versus usual care in Iranians with type 2 diabetes for the prevention of cardiovascular diseases
Design
To randomize the study, each patient is assigned a code(1 or 2) using Rand number. Conventionally, a patient who received a code of one will receive the pharmacist's care for a period of three months. It should be noted that the patients will not know what code they have received and only the researcher will be aware of this issue.
Settings and conduct
The clinical trial has two intervention and control groups, community-based and practical, with a factorial group, unblinded, randomized, on 60 patients.
Participants/Inclusion and exclusion criteria
Inclusion criteria:patients with new-onset type 2 diabetes with an age range of 18-70 years. Exclusion criteria: pregnant and lactating patients.
Intervention groups
intervention group: 30 type 2 diabetes patients who entered the study were initially checked for blood sugar, blood fat, blood pressure and the risk of cardiovascular disease, and received the care of a pharmacist for three months, and at the end of three months, again in terms of blood sugar, blood fat, blood pressure and cardiovascular risk were examined. Control group:30 type 2 diabetes patients who were included in the study were initially checked for blood sugar, blood fat, blood pressure and risk of cardiovascular disease, and they had routine care for three months and did not receive pharmaceutical care. At the end of three months, blood sugar, blood fat, and blood pressure and cardiovascular risk were investigated.
Main outcome variables
Reduction in fasting blood sugar and HbA1c, cholesterol and triglycerides, blood pressure and prediction of cardiovascular risk (FRC).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150706023084N20
Registration date: 2024-06-05, 1403/03/16
Registration timing: retrospective

Last update: 2024-06-05, 1403/03/16
Update count: 0
Registration date
2024-06-05, 1403/03/16
Registrant information
Name
MARYAM SHIEHMORTEZA
Name of organization / entity
AZAD UNIVERSITY PHARMACEUTICAL SCIENCES
Country
Iran (Islamic Republic of)
Phone
+98 212640056
Email address
shiehmorteza@iaups.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-09-23, 1401/07/01
Expected recruitment end date
2023-03-21, 1402/01/01
Actual recruitment start date
2023-01-21, 1401/11/01
Actual recruitment end date
2023-10-22, 1402/07/30
Trial completion date
2023-12-26, 1402/10/05
Scientific title
Impacts of pharmacist's medication care in type 2 diabetic to prevent cardiovascular disease
Public title
Impacts of pharmacist's medication care in diabetic
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes with age limit of 18-70 years
Exclusion criteria:
Pregnant and lactating patients
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the study, each patient is assigned a code(1 or 2) using Rand number. Conventionally, a patient who received a code of one will receive the pharmacist's care for a period of three months. It should be noted that the patients will not know what code they have received and only the researcher will be aware of this issue.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Department of Pharmaceutical Sciences,Tehran Islamic Azad University of Medical
Street address
Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch
City
Tehran
Province
Tehran
Postal code
193956466
Approval date
2022-07-26, 1401/05/04
Ethics committee reference number
IR.IAU.PS.REC.1402.068

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E11.6
ICD-10 code description
Type 2 diabetes mellitus with other specified complications

Primary outcomes

1

Description
Fasting blood sugar
Timepoint
the beginning of the study and 3 months later
Method of measurement
Laboratory blood sample

2

Description
Cardiovascular disease risk (Framingham Risk Score)
Timepoint
The beginning of the study and 3 months later
Method of measurement
Software (Framingham Risk Score)

3

Description
Hemoglobin A1c
Timepoint
The beginning of the study and 3 months later
Method of measurement
Laboratory blood sample

4

Description
Cholesterol
Timepoint
The beginning of the study and 3 months later
Method of measurement
Laboratory blood sample

5

Description
Triglycerides
Timepoint
The beginning of the study and 3 months later
Method of measurement
Laboratory blood sample

6

Description
Blood pressure
Timepoint
The beginning of the study and 3 months later
Method of measurement
Mercury sphygmomanometer

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:30 type 2 diabetes patients who were included in the study were initially checked for blood sugar, blood fat, blood pressure and the risk of cardiovascular disease, and received the care of a pharmacist for three months, and at the end of three months, again in terms of blood sugar, blood fat, blood pressure and the risk of heart complications Vasculature were examined.
Category
Treatment - Other

2

Description
Control group:30 type 2 diabetes patients who were included in the study were initially checked for blood sugar, blood fat, blood pressure and risk of cardiovascular disease, and they had routine care for three months and did not receive pharmaceutical care. At the end of three months, blood sugar, blood fat, and blood pressure and the risk of cardiovascular complications were investigated.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Bo Ali Hospital
Full name of responsible person
Hossein motamedi motlagh
Street address
Damavand street, not reaching Imam Hossein square, Bu Ali hospital
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
booali.hospital96@gmail.com

2

Recruitment center
Name of recruitment center
Farhikhtegan Hospital
Full name of responsible person
Hossein motamedi motlagh
Street address
The end of Shahid Sattari highway in the north, University Square, towards Hesarak.
City
Tehran
Province
Tehran
Postal code
1477899679
Phone
+98 21 4486 7262
Email
Farhikhteganhospital@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud parsania
Street address
Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mshi1973@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Maryam shiehmorteza
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Dr Shariati Ave., Gholhak, Yakhchal Ave., Islamic Azad University of Pharmaceutical Sciences Branch
City
Tehran
Province
Tehran
Postal code
1949635881
Phone
+98 21 2660 2642
Email
mshi1973@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No.99,Yakhchal Street., Dr shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2264 0056
Email
nazarizeynab32@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Shiehmorteza
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
No.99,Yakhchal Street., Dr shariati Ave.
City
Tehran
Province
Tehran
Postal code
1916893813
Phone
+98 21 2264 0056
Email
shiehmorteza@iaups.ac.ir

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
No - There is not 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
Data is collected as a checklist.
When the data will become available and for how long
After the intervention
To whom data/document is available
Qualified persons
Under which criteria data/document could be used
Use for scientific advancement in the field under study
From where data/document is obtainable
Clinical office of Islamic Azad University Medical science of Tehran -Faculty of Pharmacy
What processes are involved for a request to access data/document
Request in writing by going through legal procedures
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