Protocol summary

Study aim
Determining the effect of training based on pictograph on the HgA1c of diabetic patients
Design
The type of study design is parallel, with a control group, one-sided blind, randomized, phase 2 on 132 patients, the researcher selected 132 patients from among all patients with diabetes referred by simple random sampling technique. Patients were divided into two groups of 66 people based on a random table of numbers
Settings and conduct
the researcher's visit to the designated office and a diabetes clinic in Yazd, for all patients, recorded demographic information and medication adherence, health literacy based on the questionnaire, and HgA1c check at baseline and three months later. The intervention group is given drug training and the control group does not. Three months later, the quarterly blood sugar check and medication adherence questionnaire will be filled again. One-sided blinding, where only the patients do not know that the pharmacist's explanation is a type of intervention
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients over 18 years old with type 1 and type 2 diabetes Exclusion criteria: HgA1c below 7.5, oral monotherapy agent for diabetes, impaired cognitive level
Intervention groups
To the intervention group, by using verbal explanations and showing pictographs, he gave the necessary drug training to the patient (including the correct way to take it, the intervals between taking it, how to reduce side effects). The control group does not receive verbal or pictographic explanations and is satisfied with the brief explanations of the treating physician about the drugs
Main outcome variables
The primary outcome of this study was to examine changes in blood sugar for three months compared to baseline

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240220061059N3
Registration date: 2024-08-24, 1403/06/03
Registration timing: registered_while_recruiting

Last update: 2024-08-24, 1403/06/03
Update count: 0
Registration date
2024-08-24, 1403/06/03
Registrant information
Name
Golnaz Afzal
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 35 3826 7246
Email address
g.afzal@ssu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2025-07-23, 1404/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Pictograph-Based Education on medication adherence and HbA1 c Levels in Diabetic Patients: A randomize one blinded control trial
Public title
The effect of medication education on diabetic patients for controlling blood glucose
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old with type 1 and type 2 diabetes
Exclusion criteria:
Hgb1c under 7.5 Oral monotherapy diabetes Impaired cognitive status
Age
From 18 years old to 90 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 132
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are entered into two groups of 66 people, drug or intervention based on permutation block method. 22 blocks of 6 are considered. Generation of random codes will be generated using random allocation using permutation block method with the help of Random allocation software version 1. The first eligible person to enter the study is given number one, and so on until the last eligible person is given number 132. Using the table generated by the random allocation software according to the number, the intervention people (A or B) will receive each of the letters A and B installed on containers of the same shape and assigned to one of the interventions. . In order to hide the random allocation, this list will be given to another person outside the study, and before allocating the type of treatment, they will be asked according to the number of the eligible person, and in this way, people will enter the study.
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 Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Shohaday Gomnam pardis Ave, Alem square, faculty of pharmacy,shahid sadoughi university of medical science Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8915173160
Approval date
2024-05-07, 1403/02/18
Ethics committee reference number
IR.SSU.MEDICINE.REC.1403.021

Health conditions studied

1

Description of health condition studied
Diabetic patients
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Change in HgA1C
Timepoint
Baseline and 3 months later
Method of measurement
Blood sample

Secondary outcomes

1

Description
Medication adherence
Timepoint
Baseline and 3 months later
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: Intervention group: Pharmaceutical Education on Medication by oral explanations and pictographs
Category
Behavior

2

Description
Control group: not receive Pharmaceutical Education on Medication
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Private office of endocrines
Full name of responsible person
Dr Akram Ghadiri anari
Street address
Unit 10, 41 Alley, Hafez Ave, Kashani Street, Yazd, Iran
City
Yazd
Province
Yazd
Postal code
8916767754
Phone
+98 35 3827 6246
Email
ghadiriam@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Amin Salehi Abarghoee
Street address
Emem Reza complex, Emam hossein square, Yazd
City
Yazd
Province
Yazd
Postal code
8916767754
Phone
+98 35 3822 4729
Email
m.gmail@editormshsj
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Yazd 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
Yazd University of Medical Sciences
Full name of responsible person
Golnaz Afzal
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy,Shahid Sadoughi university of Medical Sciences,Alem Square, Shohaday Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8916767754
Phone
+98 35 3827 6246
Email
dr.golnaz.afzal@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Golnaz Afzal
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy,Shahid Sadoughi university of Medical Sciences,Alem Square, Shohaday Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8916767754
Phone
+98 35 3824 6246
Email
dr.golnaz.afzal@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Yazd University of Medical Sciences
Full name of responsible person
Golnaz Afzal
Position
Professor assistant
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy,Shahid Sadoughi university of Medical Sciences,Alem Square, Shohaday Gomnam Blvd, Yazd Town
City
Yazd
Province
Yazd
Postal code
8916767754
Phone
+98 35 3827 6246
Email
dr.golnaz.afzal@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
Information about the main results is shared
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Data only for researchers working in academic institutions
Under which criteria data/document could be used
If access to data is effective in better method design or analysis of new studies, it will be available to them
From where data/document is obtainable
The corresponder author should be emailed, and priority will be given to university professors and then students of specialized courses in medical sciences universities. Dr.Golnaz.Afzal@gmail.com
What processes are involved for a request to access data/document
First, the request is made by sending an email to the corresponding author and explaining the reason for requesting access to the data, after review by the corresponding author , if the reason for the data request is acceptable, the data will be provided to them.
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