Evaluating the impact of a DSME (diabetes self-management education) web-application on self-management, quality of life and glycemic indicators in patients with type 2 diabetes
Evaluating the impact of a DSME (diabetes self-management education) web-application on self-management, quality of life and glycemic indicators in patients with type 2 diabetes
Design
Clinical trial with parallel groups, without blinding, randomized, on 60 patients, random permutation block method was used for randomization.
Settings and conduct
60 patients with diabetes referring to educational pharmacies and, if necessary, diabetes clinics affiliated to Isfahan University of Medical Sciences, who have been diagnosed with type 2 diabetes, will be included in the study (based on the inclusion and exclusion criteria of the study).
After entering the study and randomly allocating patients into two intervention and control groups, the patients in the intervention group are followed up using an educational intervention program including the use of a web-based application fot diabetes self-management, and no educational intervention in the control group patients. It will not be done and they use the usual care and recommendations.
Participants/Inclusion and exclusion criteria
Patients with type 2 diabetes
patients Willing to participate in the study and sign the informed consent form
Patients who have at least high school education and have access to personal smart phones and the Internet to use the DSME web-application
Intervention groups
Intervention group: use of a DSME (diabetes self-management education) web-application
Control group: No intervention
Main outcome variables
Self-efficacy score in diabetic patients
quality of life score
Hemoglobin A1C percentage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150221021159N11
Registration date:2024-11-02, 1403/08/12
Registration timing:prospective
Last update:2024-11-02, 1403/08/12
Update count:0
Registration date
2024-11-02, 1403/08/12
Registrant information
Name
Shadi Farsaei
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 2618
Email address
farsaei@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-01-20, 1403/11/01
Expected recruitment end date
2026-01-21, 1404/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the impact of a DSME (diabetes self-management education) web-application on self-management, quality of life and glycemic indicators in patients with type 2 diabetes
Public title
Evaluating the effect of DSME (diabetes self-management education) web-application in diabetes self-management
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes
Patients who have at least high school education and have access to personal smart phones and the Internet to use the DSME web-application
Exclusion criteria:
Patients not willing to participate in the study and do not sign the informed consent form
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
60 patients are selected among the patients who are eligible to enter the study and have consented to participate in the study, and then they are randomly allocated in two groups of 30 people using random permutation blocks with size 2, 4 and 6. The randomization process of assigning patients to study groups will be done using a random list created by the software with an allocation ratio of 1:1 in the block. The random order that is created in the blocks with the relevant software will be written on cards and placed inside sealed envelopes. Then envelopes are assigned to each patient in the order of entering the study and the relevant intervention is carried out.
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
Research Ethics Committees of Schools of Pharmacy and Nutrition, Isfahan University of Medical Scien
Street address
Isfahan University of Medical Sciences, Hazar Jarib Avenue.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2024-04-16, 1403/01/28
Ethics committee reference number
IR.MUI.PHANUT.REC.1403.010
Health conditions studied
1
Description of health condition studied
type 2 diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Self-efficacy score in diabetic patients
Timepoint
At the beginning of the study and after the end of the study
Method of measurement
The questionnaire of Fapa et al
2
Description
quality of life score
Timepoint
At the beginning of the study and after the end of the study
Method of measurement
Questionnaire of Brooks et al
3
Description
Hemoglobin A1C percentage
Timepoint
At the beginning of the study and after the end of the study
Method of measurement
Laboratory test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Training based on a web application containing principles of self-care for diabetes (weight control and associated diseases), pharmacologic and non-pharmacologic measures for diabetes control, blood sugar and other laboratory tests monitoring
Category
Behavior
2
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
AL Zahra hospital
Full name of responsible person
Shadi Farsaei
Street address
Soffeh Blvd.
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3792 7071
Email
sh.farsaei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Askari
Street address
Isfahan university of medical sciences, Hezar jarib Avenue
City
Isfahan
Province
Isfehan
Postal code
8148614481
Phone
+98 31 3792 7071
Email
sh.farsaei@gmail.com
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
Shadi Farsaei
Position
associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of pharmacy, Isfahan University of Medical Sciences, Hezar Jarib Avenue.
City
isfahan
Province
Isfehan
Postal code
8148614481
Phone
+98 31 3792 7071
Fax
+98 31 3668 0011
Email
farsaei@pharm.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Farsaei
Position
Pharm. D., BCPS
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avenue.
City
Isfahan
Province
Isfehan
Postal code
8148614481
Phone
+98 31 3792 7071
Email
sh.farsaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shadi Farsaei
Position
Pharm. D., BCPS / Academic member (associate professor)
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Isfahan University of Medical Sciences, Hezar Jarib Avenue.
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7071
Email
farsaei@pharm.mui.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