The effect of web-based education on self-management and HbA1C in type 2 diabetic patients, discharged from Alzahra hospital in Isfahan in 2020
Design
Clinical trial with test and control group, Random allocation
Settings and conduct
The study is being conducted at Alzahra Hospital, Isfahan, for all patients with type 2 diabetes discharged in 2019 who meet the inclusion criteria.
First of all, we list people who meet the inclusion criteria. We will then ask for their consent to participate in the program by telephone and will list those who have consented. The samples will be randomly assigned. The test group is introduced to the training website and observed throughout the course. At the end of the training period and three months later, both groups will be re-examined with self-management questionnaire and HbA1C test.
Participants/Inclusion and exclusion criteria
Diagnosed with type 2 diabetes; Having a smartphone and a caregiver at home;
ٍExclusion criteria: Lack of chronic and advanced diabetes complications; Lack of mental retardation or psychological disorders.
Intervention groups
Intervention group: In the intervention group, at first, a how to use website guidance pamphlet and a card containing username and password to login the website will be given. in the next step, patients could watch the Health Promotion Model constructs-based training course on the website in a two week period. In addition, at the end of the training program up to 3 months after, will receive reminder messages to encourage to view the educational content uploaded on the website once a week via SMS Evaluating will be done through questionnaire before the intervention, two weeks and 3 months after intervention
Main outcome variables
Web-based educational intervention is an independent variable and self-management and HbA1C are dependent variables
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190806044449N1
Registration date:2021-01-19, 1399/10/30
Registration timing:retrospective
Last update:2021-01-19, 1399/10/30
Update count:0
Registration date
2021-01-19, 1399/10/30
Registrant information
Name
Maryamsadat Shahshahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7585
Email address
shahshahani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-09, 1399/03/20
Expected recruitment end date
2020-11-10, 1399/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of web-based education on self-management and HbA1C in type 2 diabetic patients, discharged from Alzahra hospital in Isfahan in 2020
Public title
The effect of web-based educational intervention on self-management in type diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients should be type 2 diabetics diagnosed at least one year before the research according to a physician.
They should be Persian.
The patient and his/her primary caregiver should be able to use the smart phone and have the application installed.
They should have attended at least one session in the patient education program at Al-Zahra Hospital.
Have an interest and informed consent to participate in the program.
Having a glucometer at home.
Exclusion criteria:
Diagnosed with type 1 diabetes
Experiencing chronic and advanced diabetes complications such as: nephropathy, proliferative retinopathy, amputation
Mental retardation, or diagnosis of psychological disorders before diabetes diagnosis or having a severe psychological disorder after diabetes diagnosis
Patients with long-term diabetes and no caregivers.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The subjects who were registered in the statistics office of Al-Zahra Health Education Office in 1398-99 will be selected in the initial list, then we will telephone call and explain the objectives of the study units with the main caregiver (support person). after that, The units will invitations and informed consent form and pre-test questionnaire and completed then they will be divided into two groups of test and control using randomization software (Random Allocation Software Version 1.0, May 2004).
Blinding (investigator's opinion)
Single blinded
Blinding description
The consent form is obtained from all selected individuals and then randomly divided into two groups of control and test. The control group will receive the usual training and the test group will receive the training based on the web-based teaching method. Therefore, all participants in this study are blind.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Ave., Azadi Square
City
Isfahan
Province
Isfehan
Postal code
8174673465
Approval date
2019-11-13, 1398/08/22
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.493
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Self management of diabetes
Timepoint
Completion of the questionnaire at baseline (before intervention), 21 days later and three months later
Method of measurement
Schmidt et al. Diabetes self-management questionnaire
2
Description
HbA1C changes
Timepoint
HbA1C measurement
Method of measurement
HPLC method and Siba electro-foresight device
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, at first, a how-to-use website guidance pamphlet and a card containing username and password to login the website will be given. in the next step, patients could watch the Health Promotion Model constructs-based training course on the website in a two week period. In addition, at the end of the training program up to 3 months after, will receive reminder messages to encourage us to view the educational content uploaded on the website once a week via SMS Evaluating will be done through the questionnaire before the intervention, two weeks and 3 months after the intervention. Control group: the control group patients receive routine training in the ward. Evaluating will be done through questionnaires before the intervention, two weeks, and 3 months after the end of the intervention. After doing the final measurement, participants in the control group will receive a Website`s pamphlet guidance and a card containing username and password to view educational content
Category
Rehabilitation
2
Description
Control group: 'In this group, after the initial assessment of blood sugar and evaluation through a questionnaire (routine hospital training will be done), they are asked to return again in the next three weeks.A telephone call will be made to call the participating units for the second test and three months later for the final test and HbA1C test. After the last measurement, the participants of the control group will receive a training guide for using the website and a card containing the password and username to receive the training content.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzahra Medical Center
Full name of responsible person
Majid Rezvani
Street address
Alzahra Medical Center., Safeh Boulevard.,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3620 2020
Email
alzahra@mui.ac.ir
Web page address
http://alzahra.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Tahereh Changiz
Street address
Hezar Jerib street, Isfahan
City
Isfahan
Province
Isfehan
Postal code
۷۳۴۶۱-۸۱۷۴۶
Phone
+98 31 3668 0048
Email
changiz@med.mui.ac.ir
Web page address
http://mui.ac.ir/
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Eghtedari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Department of Community Health, School of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Azadi Square, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3620 2008
Email
eghtedari.dl@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryamsadat Shahshahani
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7585
Fax
Email
shahshahani@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryamsadat Shahshahani
Position
Faculty Instructor
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jerib Street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Phone
+98 31 3792 7585
Fax
Email
shahshahani@nm.mui.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
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
Title and more details about the data/document
Results from demographic data, questionnaires and blood tests can be shared anonymously.
The study protocol will be announced.
When the data will become available and for how long
Start access period after printing results
To whom data/document is available
According to the research title, all interested people will have access to the results.
Under which criteria data/document could be used
The results will be published in scientific journals and in addition ; the researchers' emails will be available
From where data/document is obtainable
The way to communicate is emales.
shahshahani@nm.mui.ac.ir
eghtedari.dl@gmail.com
What processes are involved for a request to access data/document
It will be answered at least 1 week after request.
Comments
Only the results and study protocol will be presented.