The effect of digital games on self-management of type 2 diabetic patients
Design
Clinical trial with control group, with parallel groups, not blinded, randomized, phase 2 on 104 patients. The RANDBETWEEN function of Excel software was used for randomization.
Settings and conduct
Background: Patients with type 2 diabetes
Location: Diabetes Clinic and Endocrinologist's Office in Mashhad
How to do it: After providing explanations to patients who have been diagnosed with type 2 diabetes, and considering the inclusion criteria, they are randomly assigned to the intervention or control group.
Methods: In the intervention group, a self-management game application will be installed on their phone and the necessary explanations will be provided to them. In the control group, according to the usual procedure and without any intervention, examination, training and treatment will be performed by the treating physician.
There is no possibility of blindness in this research.
Participants/Inclusion and exclusion criteria
inclusion criteria
informed consent, diagnosis of type 2 diabetes, having a smartphone, does not have eye complications, 25 to 65 years old
exclusion criteria
Cancellation of continuing cooperation , the occurrence of eye complications of diabetes
Intervention groups
Intervention group: The group receiving digital game training for self-care patients with type 2 diabetes
Control group: group receiving routine care
Main outcome variables
HBA1C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210524051382N1
Registration date:2021-08-07, 1400/05/16
Registration timing:prospective
Last update:2021-08-07, 1400/05/16
Update count:0
Registration date
2021-08-07, 1400/05/16
Registrant information
Name
Sara Ghodousi moghadam
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2429
Email address
ghodousims971@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-23, 1400/07/01
Expected recruitment end date
2022-09-23, 1401/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of digital games on self-management of type 2 diabetic patients
Public title
The effect of digital games on self-management of type 2 diabetic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
informed satisfaction and willingness to participate in the study
Diagnosis of type 2 diabetes
Having a smartphone with Android operating system
The patient has no ocular complications (due to limited mobile work)
Patients range in age from 25 to 65 years
Exclusion criteria:
Withdrawal from continuing cooperation at any point in time
Incidence of ocular complications of diabetes
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
104
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Block randomization with size 4
Randomization tool: Excel software
Hiding method: using matte envelopes
Method: After generating a random chain in Excel software, the generated codes are written on the Opaque envelopes and then the patients receive their envelopes in order to enter the study.
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
Ethics committee of Mashhad University of Medical Sciences
Street address
Deputy of Research and Technology, Ghorashi Building, next to Hoveyzeh Cinema, University Street
City
مشهد
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2021-07-17, 1400/04/26
Ethics committee reference number
IR.MUMS.REC.1400.105
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Average blood sugar of patients (HBA1C)
Timepoint
Start of study - about 3 months after the start of the study - about 6 months after the start of the study
Method of measurement
glucometer and clinical laboratory
Secondary outcomes
1
Description
knowledge
Timepoint
Start of study - about 3 months after the start of the study - about 6 months after the start of the study
Method of measurement
KAP (Knowledge, Attitude and Practice) Questionnaire
2
Description
Diabetes comorbidity
Timepoint
end of study
Method of measurement
medical records
3
Description
Quality of life
Timepoint
Beginning and end of the study
Method of measurement
Quality Of Life questionnaire
Intervention groups
1
Description
Control group: Receiving routine care in the diabetes clinic, including examination, education and treatment of patients with type 2 diabetes by the treating physician without any changes or interventions
Category
Lifestyle
2
Description
Intervention group: Digital game of self-management training for type 2 diabetic patients, which is installed on patients' mobile phones and uses game techniques, necessary training on proper diabetic nutrition, proper drug use and the importance of physical activity, depending on Each patient's condition is given in the form of educational and motivational messages during the game.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Office of Dr. Zahra Mazlum Khorasani
Full name of responsible person
Dr. Zahra Mazlum Khorasani
Street address
Unit 705, Waterfall Building, between Moallem 8 and 10, Moallem Boulevard
City
Mashhad
Province
Razavi Khorasan
Postal code
9188879287
Phone
+98 51 3601 7449
Email
MazloumZ@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi Piadeh Gheibi
Street address
Department of Medical Informatics, School of Medicine, University of Medical Sciences, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
MDS.Dean@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Zahra Mazloum Khorasani
Position
Associate Professor of Internal Medicine
Latest degree
Subspecialist
Other areas of specialty/work
Internal Medicine
Street address
Department of Internal Medicine, School of Medicine, Metabolic Syndrome Research Center, Ghaem Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
MazloumZ@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamed Tabesh
Position
Assistant Professor of Biostatistics
Latest degree
Ph.D.
Other areas of specialty/work
Biostatistics
Street address
Department of Medical Informatics, School of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
tabeshh@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
sara ghoddousi moghaddam
Position
student
Latest degree
Ph.D.
Other areas of specialty/work
Medical Informatics
Street address
Department of Medical Informatics, School of Medicine, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2000
Email
ghodousims971@mums.ac.ir
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
There is no more information
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
After the publication of the article
When the data will become available and for how long
After the publication of the article
To whom data/document is available
After the publication of the article
Under which criteria data/document could be used
After the publication of the article
From where data/document is obtainable
After the publication of the article
What processes are involved for a request to access data/document