Determine and compare the attitudes of type 2 diabetic women about self-care behaviors before and 3 months after intervention in the control and experimental group
Design
The study was a controlled clinical trial, semi experimental, and prospective interventional, with parallel groups, one blind, randomized
Settings and conduct
Before the educational intervention, the questionnaire was completed by both the control and experimental groups and Both patients were referred to the Fatemiyeh Clinic Lab with introduction letter for checking HbA1c test. Educational intervention was conducted for the experimental group in the form of 10 training sessions.Three months after the intervention, the questionnaire was completed by both the experimental and control groups. The patients were referred for checking HbA1c test and the results were recorded.
Participants/Inclusion and exclusion criteria
Patients who have at least one year of diabetes history; Have literacy to read and write; age over 30 years old will be included in the study.
Exit criteria are: patients with hypertension and history of mental disorders
Intervention groups
10 sessions, including 60 minutes of lectures, group discussion, question and answer, use of educational videos were created for the intervention group. At the end of the sessions, an educational book was given to them.The WhatsApp Group was formed for the exchange of information. A monthly follow-up meeting was held to conduct their care and exchange of views. Control group members were deprived of training sessions.
Main outcome variables
Self-care behaviors in diabetic patients participating in the study; Measure the constructs of the theory of reasoned action; Attitude of women with type 2 diabetes about self-care behaviors; Behavioral intention of women with type 2 diabetes about self-care behaviors; HbA1c levels in patients with type 2 diabetes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180707040372N1
Registration date:2018-09-29, 1397/07/07
Registration timing:retrospective
Last update:2018-09-29, 1397/07/07
Update count:0
Registration date
2018-09-29, 1397/07/07
Registrant information
Name
Forough Faghih
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3842 9382
Email address
f.faghih@fums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-22, 1396/11/02
Expected recruitment end date
2018-02-05, 1396/11/16
Actual recruitment start date
2018-02-12, 1396/11/23
Actual recruitment end date
2018-02-21, 1396/12/02
Trial completion date
2018-06-10, 1397/03/20
Scientific title
The Effect of Educational Program on Self-care Behaviors Based on Theory Reasoned Action in Women Patients Type II Diabetes
Public title
The Effect of Educational Program on Self-care Behaviors in Women Patients Type II Diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetic women who have diabetes for at least 1 year
Have literacy to read and write
Diabetic women aged over 30
Exclusion criteria:
Age
From 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Actual sample size reached:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly & alternately divided into two groups of control and test according to case number.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, blinding will be done on participants in the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Fasa University of Medical Sciences
Street address
Fasa university of medical sience, Ebne sina square
City
ّFasa
Province
Fars
Postal code
7461686688
Approval date
2018-06-19, 1397/03/29
Ethics committee reference number
IR.FUMS.REC.1397.25
Health conditions studied
1
Description of health condition studied
Diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Self-care behaivior
Timepoint
Before the intervention and three months after the end of the intervention
Method of measurement
Questionnaire Measuring self-care behaviors
Secondary outcomes
1
Description
Attitude and belief of participants in the study toward self-care behaviors
Timepoint
Before the intervention and three months after the end of the intervention
Method of measurement
A questionnaire that measures the constructs of the theory of reasoned action
Intervention groups
1
Description
Intervention group: Ten training sessions featuring educational videos, PowerPoint for 55 to 60 minutes in three weeks
Category
Behavior
2
Description
Control group:do not do extra work
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Forough Faghih
Street address
Shariati hospital, Fayaz bakhsh Street, Fasa Town
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5335 0116
Email
f.faghih@fums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr.Mojtaba Farjam
Street address
Fasa University of Medical Science, Ebne Sina Square, Fasa Town
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5331 6300
Email
farjam@fums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Fasa 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
Fasa University of Medical Sciences
Full name of responsible person
Dr. Ali Khani Jeihouni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
Fums, Ebne Sina Square, Fasa Town
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 987153316300
Email
khani_1512@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Dr. Ali Khani Jeihouni
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Public Health
Street address
Fums, Ebne Sina Square, Fasa Town
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 987153316300
Email
khani_1512@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Fasa University of Medical Sciences
Full name of responsible person
Forough Faghih
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
Fums, Ebne Sina quare,Fasa Town
City
Fasa
Province
Fars
Postal code
7461686688
Phone
+98 71 5331 6300
Email
f.faghih@fums.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
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
All data is shared
When the data will become available and for how long
6 months after printing results
To whom data/document is available
Researchers working in academia
Under which criteria data/document could be used
Any kind of analysis on the data is allowed
From where data/document is obtainable
executor of Plan. Email adress: forough.faghih@yahoo.com
What processes are involved for a request to access data/document
Send an academic email to the project facilitator and supervisor