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Comparison of the effect of healthy lifestyle education through peer education and virtual education (based on Interactive virtual classroom and applications) on indicators of lifestyle that promotes health, self-esteem and self-efficacy of diabetics referred to military hospitals

Protocol summary

Study aim
Comparison of the effect of healthy lifestyle education through peer education and virtual education on indicators of lifestyle that promotes health, self-esteem and self-efficacy of diabetics referred to military hospitals
Design
Clinical trial with control group, with parallel groups, without blinding, by Convenience Sampling, on 135 patients.
Settings and conduct
In three groups of peer education, virtual education and control will be done in the medical centers of the Army University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Inclusion criteria: at least six months of diagnosis of uncontrolled type 2 diabetes, 21 to 75 years of age, no history of participation in diabetes education programs in the last six months, the possibility of installing software in the mobile phone and Internet access, lack of cognitive problems, physical disabilities, hearing or vision impairment. Exclusion criteria: the new physical problem resulting disability, Reluctance to participate, no ability to use the software.
Intervention groups
Peer training group: Peer training, through trained peers in the form of face-to-face training with classes, lectures, and questions and answers through 4, 35 minutes sessions. Virtual education group: The prepared educational program including clip, image, audio, text, and application will be provided to patients in three sessions every other day for two months in a virtual education group. Control group: no intervention.
Main outcome variables
Health-promoting lifestyle; Self-esteem; Self-efficacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20210808052115N1
Registration date: 2021-10-06, 1400/07/14
Registration timing: registered_while_recruiting

Last update: 2021-10-06, 1400/07/14
Update count: 0
Registration date
2021-10-06, 1400/07/14
Registrant information
Name
Azad Fatahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 4629 5184
Email address
azad8271@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-05, 1400/06/14
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of healthy lifestyle education through peer education and virtual education (based on Interactive virtual classroom and applications) on indicators of lifestyle that promotes health, self-esteem and self-efficacy of diabetics referred to military hospitals
Public title
The effect of healthy lifestyle education through peer education and virtual education (based on Interactive virtual classroom and applications) on indicators of lifestyle that promotes health, self-esteem and self-efficacy of diabetics
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least six months have passed since the diagnosis of uncontrolled type 2 diabetes based on the fasting blood sugar index above 126 mg / dL. Have an age range between 21 and 75 years Have no history of participating in diabetes education programs during the past six months. Willingness to participate in the present study. Be literate and use a smartphone. Be able to speak Persian. Mobile access and the ability to use it Ability to install software on mobile phones and Internet access Do not have cognitive problems, physical disabilities, need for diabetic foot surgery, No medical or related education Absence of hearing or vision impairment Not be a part of treatment staff Possibility to make direct telephone calls to the patient and his active family member.
Exclusion criteria:
The patient develops new physical problems that make them lose the ability to take care of themselves. Reluctance to cooperate the study Do not use software
Age
From 21 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 135
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation clause will be used. To randomly assign patients to three groups of peer education, virtual education and control, the six-random block method is used as follows. Groups will be assigned letters A, B and C randomly (BCACAB, BACCAB, ABCBAC, CBAACB blocks). In this method, blocking is based on the week and possible blocks are selected randomly. For example, patients who visit the Armed Forces Hospital in the endocrine ward in the first week enter control group B. Patients in the second week are in the peer education group C in the third week are in the virtual education group A, and so on blockchain is continued until so many blocks are selected It is possible to obtain the required sample size.
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
AJA University of Medical Sciences
Street address
Tehran, Ghods Town (West), between South Flamek and Zarafshan, Iran TV St. - Headquarters of the Ministry of Health, Treatment and Medical Education, Block A, 13th floor
City
Tehran
Province
Tehran
Postal code
6797168353
Approval date
2021-09-08, 1400/06/17
Ethics committee reference number
IR.AJAUMS.REC.1400.131

Health conditions studied

1

Description of health condition studied
diabetes mellitus
ICD-10 code
E11.9
ICD-10 code description
Type 2 diabetes mellitus without complications

Primary outcomes

1

Description
Health Promoting Lifestyle Indicators
Timepoint
Before the intervention and two months later, patients in all three groups are assessed using a questionnaire promoting health
Method of measurement
Walker Health Promoting Lifestyle Questionnaire (HPLPII)

2

Description
Self-Esteem
Timepoint
Before the intervention and two months later, patients in all three groups are assessed using a questionnaire self-esteem
Method of measurement
Rosenberg Self-Esteem Questionnaire

3

Description
Self-Efficacy
Timepoint
Before the intervention and two months later, patients in all three groups are assessed using a self-efficacy of diabetic patients questionnaire .
Method of measurement
Type 2 Diabetic Self-Efficacy Questionnaire (DMSES)

Secondary outcomes

empty

Intervention groups

1

Description
Peer Education Intervention group: In the present study, the purpose of peer education is to provide face-to-face training through trained peers by holding classes, lectures and questions and answers for 4 sessions of 35 minutes.
Category
Lifestyle

2

Description
Virtual education intervention group (based on interactive virtual classroom and application): A virtual education program designed by the researcher that includes how to take care of themselves such as diet and activity, etc. The researcher implemented a training program The training program includes a clip , Image, audio, text and application are provided to patients in three sessions every other day for two months in a virtual training group.
Category
Lifestyle

3

Description
Control group: without any intervention by researchers
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
AJA Medical Sciences Hospitals
Full name of responsible person
Azad Fatahi
Street address
AJA University of Medical Sciences - - West Fatemi St. End of Etemadzadeh St. Tehran
City
Tehran
Province
Tehran
Postal code
6797168353
Phone
+98 21 8609 6350
Email
azad8271@gail.com
Web page address
https://www.ajaums.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Seyede Azam Sajadi
Street address
Shahid Etemadzadeh St., West Fatemi St., Tehran
City
Tehran
Province
Tehran
Postal code
6797168353
Phone
+98 21 8609 6350
Email
azad8271@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Azad Fatahi
Position
master of medical surgical nursing. non-faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
safiabad village
City
javanrood
Province
Kermanshah
Postal code
6797168353
Phone
+98 83 4629 5184
Email
azad8271@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Azad Fatahi
Position
master of medical surgical nursing. non-faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
safiabad village
City
javanrood
Province
Kermanshah
Postal code
6797168353
Phone
+98 83 4629 5184
Email
azad8271@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Azad Fatahi
Position
Master of Internal Surgery Nursing, non-faculty
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
safiabad village
City
javanrood
Province
Kermanshah
Postal code
6797168353
Phone
+98 83 4629 5184
Email
azad8271@gmail.com

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
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