Protocol summary

Study aim
Comparing the effects of mobile-based, group and routine educations on self-care behaviors of patients with type 2 diabetes
Design
In this research, 90 eligible patients with type 2 diabetes referred to Ahvaz Golestan and Emam Ghomaini hospitals will be chosen. Patients will be allocated to three equal groups of mobile-based, group and routine educations according to block randomization method.
Settings and conduct
This intervention study will be conducted on Ahvaz Golestan and Emam Ghomaini hospitals.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having 18-60 years old; confirmation the diagnosis of type 2 diabetes by specialist; having ability to response questions and to participate in educational sessions; having reading ability; having mobile phone with ability to use designed software; being resident in Ahvaz city; familiarity with Persian language. Exclusion criteria: Having history of any chronic diseases and mental disorders like delirium and learning disorders.
Intervention groups
First intervention group will receive education using mobile phone software related self-care behaviors of diabetes during 2 months. Second intervention group will receive group training related self-care behaviors of diabetes in 8 sessions weekly during 2 months. Control group will receive hospital routine during 2 months
Main outcome variables
Self-care behaviors

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180104038215N1
Registration date: 2018-03-03, 1396/12/12
Registration timing: registered_while_recruiting

Last update: 2018-03-03, 1396/12/12
Update count: 0
Registration date
2018-03-03, 1396/12/12
Registrant information
Name
Samaneh Rahnavard
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4252 1923
Email address
rahnavard.s@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-04-10, 1397/01/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of mobile-based, group and routine educations on self-care behaviors of patients with type 2 diabetes
Public title
Comparing the effects of mobile-based education and group training on self-care behaviors of patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having 18-60 years old Confirmation the diagnosis of type 2 diabetes by specialist Having ability to response questions and to participate in educational sessions Having reading ability Having mobile phone with ability to use designed software Being resident in Ahvaz city Familiarity with Persian language
Exclusion criteria:
Having history of any chronic diseases and mental disorders like delirium and learning disorders
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be allocated to three equal groups of first intervention, second intervention, and control according to block randomization method.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this project patients will be blinded to groups allocation.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Ahvaz Jundishapur University of Medical Sciences
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-10-28, 1396/08/06
Ethics committee reference number
IR.AJUMS.REC.1396.604

Health conditions studied

1

Description of health condition studied
Type 2 diabetes
ICD-10 code
E11.8
ICD-10 code description
Type 2 diabetes mellitus with unspecified complications

Primary outcomes

1

Description
Self-care behaviors
Timepoint
Before intervention and 2 month after intervention
Method of measurement
The summery of diabetes self-care activities questionnaire

Secondary outcomes

1

Description
Hemoglobin A1c
Timepoint
Before intervention and 2 month after intervention
Method of measurement
Based on patients laboratory sheet

Intervention groups

1

Description
First intervention group: will receive education using mobile phone software related self-care behaviors of diabetes during 2 months.
Category
Lifestyle

2

Description
Second intervention group: will receive group training related self-care behaviors of diabetes in 8 sessions weekly during 2 months.
Category
Lifestyle

3

Description
Control group: will receive hospital routine during 2 months.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ahvaz Golestan hospital
Full name of responsible person
Samaneh Rahnavard
Street address
Golestan hospital, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135733118
Phone
+98 61 3374 3001
Fax
Email
s_r8088@yahoo.com

2

Recruitment center
Name of recruitment center
Ahvaz Imam Khomeyni hospital
Full name of responsible person
Samaneh Rahnavard
Street address
Imam Khomeyni hospital, Azadegan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6193673111
Phone
+98 61 3222 2922
Email
s_r8088@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research of Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Dr. Behzad Sharif Makhmalzadeh
Street address
Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
s_r8088@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Ahvaz Jundishapur 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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Samaneh Rahnavard
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Midwifery and Nursing, Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
S_r8088@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Nasrin Elahi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Midwifery and Nursing, Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 9092
Email
Elahi-n@ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Samaneh Rahnavard
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Midwifery and Nursing, Ahvaz Jundishapur University of Medical Sciences, Golestan road, Ahvaz, Khozestan
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8331
Email
s_r8088@yahoo.com

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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only a part of patients demographical data and main outcomes will be shared.
When the data will become available and for how long
Six months after data publishing
To whom data/document is available
Data will be available only for researchers working on academic and university associations.
Under which criteria data/document could be used
Mention of study name and authors name
From where data/document is obtainable
Samaneh Rahnavard: School of Nursing and Midwifery, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran
What processes are involved for a request to access data/document
At last one month after request
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