Protocol summary

Summary
Aim: The purpose of this study was determining the effect of mobile learning (m_learning) on development of public health; so we conducted a quasi- experimental study and intervention in 2011. Methods: Hundred patients with type 2 diabetic who refer to the diabetic center in Karaj, were randomly assigned to intervention group (n=50) and control group (n= 50). Inclusion criteria: Being able to basic reading and writing, age over thirty years old, being satisfied to participate in the study (intervention or control group), patient or one of his/ her family member’s accessibility to the mobile phone. Exclusion criteria: Serious diabetic complication and psychological disorders should not be presented. Mobile education was considered for intervention group in nature of type 2 diabetes, complications, diet, exercise, drags, examination, during three months but in this period the control group received no training. The information about the individual characteristics, knowledge, attitude, practice (KAP) and self efficacy questionnaire and blood sampling was taken to measure fasting blood sugar, HgA1c, cholesterol total, LDL, HDL, triglyceride, microalbumin, bun, and creatinine before and after the intervention. Finally we compared above changeable between groups and before and after the intervention.

General information

Acronym
Mobile Health
IRCT registration information
IRCT registration number: IRCT201112158416N1
Registration date: 2011-12-24, 1390/10/03
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2011-12-24, 1390/10/03
Registrant information
Name
Mandana Goodarzi
Name of organization / entity
Islamic Azad University- Karaj Branch
Country
Iran (Islamic Republic of)
Phone
+98 26 1445 0614
Email address
mandana.goodarzi@kiau.ac.ir
Recruitment status
Recruitment complete
Funding source
Payame Noor university-Tehran
Expected recruitment start date
2011-06-22, 1390/04/01
Expected recruitment end date
2011-09-23, 1390/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of distance education on public health emphasis via mobile phone (cell phone)
Public title
Effect of training via mobile phone on public health
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Being able to basic reading and writing; age over thirty years old; being satisfied to participate in the study (intervention or control group); patient or one of his/ her family member’s accessibility to the mobile phone and HgA1c>7. Exclusion criteria: Serious diabetic complication and psychological disorders.
Age
From 30 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethic committe of Islamic Azad Uniyersity- Karaj Branch
Street address
Cross road of Moazen Blv and Esteghlal Blv, Goohardasht,Karaj, Mailbox: 314850313
City
Karaj
Postal code
Approval date
2011-06-07, 1390/03/17
Ethics committee reference number
0025

Health conditions studied

1

Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Knowledge
Timepoint
Before the intervention and three month after intervention
Method of measurement
KAP questionnaire

2

Description
Practice
Timepoint
Before the intervention and three months after intervention
Method of measurement
KAP questionnaire

3

Description
Attitude
Timepoint
Before the intervention and three months after intervention
Method of measurement
KAP questionnaire

4

Description
Self efficacy
Timepoint
Before the intervention and three months after intervention
Method of measurement
Self efficacy questionnaire

5

Description
Fasting Blood Sugar
Timepoint
Before the intervention and three months after intervention
Method of measurement
Blood sample and laboratory measurement

6

Description
HgA1C
Timepoint
Before the intervention and three months after intervention
Method of measurement
Blood sample and laboratory measurement

7

Description
Blood lipids
Timepoint
Before the intervention and three months after intervention
Method of measurement
Blood sample and laboratory measurement

Secondary outcomes

empty

Intervention groups

1

Description
intervention group: Training via mobile phone about diabetes type2
Category
N/A

2

Description
control group: Did not receive any intervention
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Karaj Diabetes Society
Full name of responsible person
Mandana Goodarzi
Street address
City
Karaj

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Payame Noor University
Full name of responsible person
Issa Ebrahimzadeh
Street address
Minicity-Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Payame Noor University
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University- Karaj Branch
Full name of responsible person
Mandana Goodarzi
Position
Distance Education Phd.student
Other areas of specialty/work
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Goohardasht,Karaj, Mailbox: 314850313
City
Karaj
Postal code
Phone
+98 26 1445 0614
Fax
Email
mandana.goodarzi@kiau.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University- Karaj Branch
Full name of responsible person
Mandana Goodarzi
Position
Distance Education Phd.Student
Other areas of specialty/work
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Goohardasht,Karaj, Mailbox: 314850313
City
Karaj
Postal code
Phone
+98 26 1445 0614
Fax
+98 44 03254
Email
mandana.goodarzi@kiau.ac.ir; mandana.godarzi@kiau.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University- Karaj Branch
Full name of responsible person
Mandana Goodarzi
Position
Distance Education Phd.Student
Other areas of specialty/work
Street address
Crossroad of Moazen Blv and Esteghlal Blv, Goohardasht,Karaj, Mailbox: 314850313
City
Karaj
Postal code
Phone
+98 26 1445 0614
Fax
Email
mandana.goodarzi@kiau.ac.ir; mandana.godarzi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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