The overall aim of this study is to determine the effect of the theory-based education on the predictive structures of eye care behavior in patients with type 2 diabetes.
Design
Firstly, we refer to the Debit City Clinic, and we will list all people who have been diagnosed with a disease for at least 5 years and who do not have clammy complications based on patient records. Then, from this locite, 94 people were selected by simple random sampling and assigned randomly into two groups of control and intervention.
Settings and conduct
Intervention - Arak Diabetes Clinic
Participants/Inclusion and exclusion criteria
Diabetic patients who have been diagnosed with at least 5 years of age.
Patients who have not experienced eye problems at the time of the study
Patients aged 40 to 60 years
Individuals with a minimum education degree
Intervention groups
In this study, according to the existing studies and available studies, the most powerful predictive structures of eye care in diabetic patients were selected based on the theory of planned behavior and the health belief model (Khani et al.) And based on their respective structures Educational intervention is carried out on patients. According to available sources, the most predictive constructs are the components of consciousness (19%), perceived sensitivity (31%), perceived barriers (19%), attitude (18%), subjective norm (11%), perceived behavioral control (18%) and behavioral intention (25%) that intervention will be performed on the promotion of these structures in the case group and compared with the control group receiving routine training.
Main outcome variables
Preventing diabetic eye complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180819040834N1
Registration date:2019-05-08, 1398/02/18
Registration timing:retrospective
Last update:2019-05-08, 1398/02/18
Update count:0
Registration date
2019-05-08, 1398/02/18
Registrant information
Name
Seyed Shahriar Hoseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3367 8625
Email address
shahriyar.hoseni95@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-01, 1397/04/10
Expected recruitment end date
2018-10-02, 1397/07/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of theory-based education on eye care of type 2 diabetic patients referred to Diabetes Clinic of Arak city in 2018
Public title
The effect of theory-based education on eye care of type 2 diabetic patients referred to Diabetes Clinic of Arak city in 2018
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic patients who have been diagnosed with at least 5 years of age
Patients who have not experienced eye problems at the time of the study
Patients aged 40-60 years with minimum education
Exclusion criteria:
exclusion criteria is patient are not willing to participate in this research.
Affected by diabetes ocular complications
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
94
Randomization (investigator's opinion)
Randomized
Randomization description
A list of case records of all diabetic patients referred to the Diabetes Clinic of Arak city, and then the number of cases related to patients with exclusion criteria (including diabetic patients who have been diagnosed with ocular complications during the diagnosis of a doctor, patients less than 5 years old with Diabetics are diagnosed, people with less education than guidance and dissatisfaction) have been excluded from participating in an identifiable study. The remaining files were entered in SPSS software. Then, 47 patients were randomly selected for the intervention group and the selected files were removed from the list. Again, with the simple random sampling method, 47 other file numbers for the group Control is selected.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The participants were randomly selected (based on the clinical records) and then randomly assigned by the relevant software (www.randomizer.com) into one of the intervention and control groups.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
Arak School of Public Health
City
Arak
Province
Markazi
Postal code
3814877991
Approval date
2018-05-13, 1397/02/23
Ethics committee reference number
IR.ARAKMU.REC.1397.045
Health conditions studied
1
Description of health condition studied
Diabetes mellitus type II
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Preventing diabetic eye complications
Timepoint
Three months
Method of measurement
Health Belief Model Structures Questionnaire and Planned Behavior Theory
Secondary outcomes
1
Description
Prevention of diabetic eye disease
Timepoint
three mounth
Method of measurement
questionnaire
2
Description
Behavioral intention
Timepoint
three month
Method of measurement
questionnaire
3
Description
Perceived behavioral control
Timepoint
three month
Method of measurement
questionnaire
4
Description
knowledge
Timepoint
three month
Method of measurement
questionnaire
Intervention groups
1
Description
Intervention group: Educational intervention for this group takes place within one month through interactive educational, booklet, seminars and the presentation of educational pamphlets as reminders, and no drugs are prescribed
Category
Prevention
2
Description
Control group: .Control group: There are no educational or pharmaceutical interventions in this group.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Diabetes Clinic
Full name of responsible person
Fatemeh Karimi
Street address
Daraei Square., Arak City
City
Arak
Province
Markazi
Postal code
3818146851
Phone
+98 86 3222 1891
Email
behdasht@arakmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dr Mohammad Arjmandzadegan
Street address
Basij Squar, Sardasht, Arak University of Medical Sciences, Deputy of Research and Technology
City
Arak
Province
Markazi
Postal code
3848176341
Phone
+98 86 3417 3639
Fax
+98 86 3417 3645
Email
research@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vcr/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Seyed Shahriar Hosseini
Position
Master Student in Health Education
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Building No. 2 of Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
۳۸۱۸۱۴۶۸۵۱
Phone
+98 86 3367 8625
Fax
+98 86 3367 8633
Email
behdasht@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vch/fa
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyed Shahriar Hosseini
Position
Master Student in Health Education
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Building No. 2 of Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
۳۸۱۸۱۴۶۸۵۱
Phone
+98 86 3367 8625
Fax
+98 86 3367 8633
Email
behdasht@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vch/fa
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Seyed Shahriar Hosseini
Position
Master Student in Health Education
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Building No. 2 of Arak University of Medical Sciences
City
Arak
Province
Markazi
Postal code
۳۸۱۸۱۴۶۸۵۱
Phone
+98 86 3367 8625
Fax
+98 86 3367 8633
Email
behdasht@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/vch/fa
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Maintain confidentiality of participants' information