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Effect of education on awareness , function and blood glucose of type 2 diabetics patients

Protocol summary

Study aim
Determining the effect of education on knowledge, practice and self-care and control of blood sugar in patients with type 2 diabetes
Design
A clinical trial without control group and without randomization will be performed on 40 diabetic patients to determine the effect of education on knowledge, performance and self-care and blood sugar control.
Settings and conduct
This study will be performed in Shahid Beheshti Hospital in Hamadan without blinding. Patients will be trained in one session by the researcher and will be assessed once before training and once two months after training for knowledge, function, blood sugar and hemoglobin A1c.
Participants/Inclusion and exclusion criteria
Participants will be type 2 diabetic patients over 30 years old who will go to Shahid Beheshti Hospital in Hamadan for routine care. Have no history of neurological-cognitive-psychological disorders and have the satisfaction to participating in the study is the inclusion criteria to the study and not having the minimum literacy, hemoglobin A1c under 7, receiving relevant training in the last 6 months, and type 1 diabetes will be criteria for not enrolling in the study.
Intervention groups
In this study, diabetic patients in the fields of: responsibility, factors affecting blood sugar control, diet and food units, exercise, insulin use method and insulin injection sites, glucometer use, foot care, signs and symptoms of hypoglycemia and hyperglycemia -lifestyle changes, smoking cessation benefits will be taught. Each training session will last about 30 minutes. Patients are asked to contact the researcher if needed or any problems or questions.
Main outcome variables
The main outcomes of the study include changes in the level of knowledge, function, blood sugar and hemoglobin A1c in diabetic patients compared to before the intervention.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N12
Registration date: 2020-08-10, 1399/05/20
Registration timing: retrospective

Last update: 2020-08-10, 1399/05/20
Update count: 0
Registration date
2020-08-10, 1399/05/20
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-29, 1399/03/09
Expected recruitment end date
2020-08-09, 1399/05/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education on awareness , function and blood glucose of type 2 diabetics patients
Public title
Effect of education on awareness , function and blood glucose of diabetics patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes No Neurobehavioral -disorders Age over 30 years Having the consent to participate in the study
Exclusion criteria:
Lack of minimum literacy Hemoglobin A1c below 7 Receive related education in the last 6 months Diabetes type 1
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Hamadan Univercity of Medical Science
Street address
Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2020-02-28, 1398/12/09
Ethics committee reference number
IR.UMSHA.REC.1398.1056

Health conditions studied

1

Description of health condition studied
Diabetes type2
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Knowledge
Timepoint
Before and 2 months after intervention
Method of measurement
Questionnaire

2

Description
Attitude
Timepoint
Before and 2 months after intervention
Method of measurement
Questionnaire

3

Description
Practice
Timepoint
Before and 2 months after intervention
Method of measurement
Questionnaire

Secondary outcomes

1

Description
HbA1c
Timepoint
Before and 3 months after intervention
Method of measurement
Blood sample

2

Description
FBS
Timepoint
Before and 3 months after intervention
Method of measurement
Blood sample

Intervention groups

1

Description
Intervention group: This group, in groups of 3 during a session for 30 minutes by a researcher (medical student) in the field of diet and food units, the need for exercise, the method of using insulin and insulin injection sites, the method of using a glucometer, Foot care, smoking cessation, how to control blood sugar, how to prevent and care for daily, signs and symptoms of hypoglycemia and hyperglycemia and the need for regular visits by a doctor and blood pressure control will be taught. Following that, patients will be followed up by phone every 2 weeks to answer any questions they may have.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
dr Firozeh Sajedi
Street address
Eram Blv, Ghaem Sq, Hamedan, Iran
City
Hamedan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0283
Email
Shahidbeheshti@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
dr Saeid Bashirian
Street address
Shahid Fahmide Ave
City
Hamedan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
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
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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamadan, Shahid Fahmideh Avenue, Medical School, Department of Social Medicine
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Firozeh Sajedi
Position
Anesthesiology MD
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Shahid Beheshti hospital, Eram Blv, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517953371
Phone
+98 81 3838 0092
Fax
Email
dsmbszolhavarieh@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
Coach
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Hamedan Shahid Fahmideh street medicine school
City
Hamَadan
Province
Hamadan
Postal code
08138380572
Phone
+98 81 3838 0097
Fax
+98 81 3838 0208
Email
a.moradi@umsha.ac.ir

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
Undecided - It is not yet known if there will be 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
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