Protocol summary

Summary
(1) Objective: The effect of the telenursing using a mobile application on the life style and glycosylated hemoglobin in patients with type 2 diabetes. (2) Design: randomized clinical trial. (3) Setting and conduct:132 diabetic patients referred to diabetes clinic in Shiraz elected who wish to participate in the study. Completion lifestyle questionnaire and Will be measured testing HbA1C, blood pressure, height and weight and is calculated BMI all participants, Then people will be divided into two experimental and control groups with randomly assigned. Educational content through software that is installed on the mobile phone given to the intervention group. The control group will participate in routine clinic classes. Three months later complete lifestyle questionnaires and Will be measured testing HbA1C, blood pressure and weight and is calculated BMI all participants.(4) Inclusion criteria: Diabetes Mellitus Type II and requires daily injections of insulin; consent to participate in the study; Having a mobile phone with the ability to install application. (5) Exclusion criteria: Not wanting to continue participating in study; Hospitalization. (6) Interventions: The use of educational software of mobile for patients with diabetes. (7) main outcome measures: changes in life style and reduce HbA1C.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101630320N1
Registration date: 2016-11-12, 1395/08/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-11-12, 1395/08/22
Registrant information
Name
Zahra Jalali
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
stud5479756036@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellery for research affairs
Expected recruitment start date
2016-11-20, 1395/08/30
Expected recruitment end date
2017-02-18, 1395/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of the telenursing using a mobile application on the lifestyle and glycosylated hemoglobin in patients with type 2 diabetes referred to diabetes center of Motahari clinic 1395
Public title
The effect mobile application on blood sugar control and lifestyle diabetics
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Diabetes Mellitus Type II and requires daily injections of insulin (based on the detection endocrinologist, citing patient record); The minimum literacy education (the educated are not medical science.); Traverse at least one year of their infection diagnosed diabetes (condition is stabilized); Having the ability to understand content based on investigator judgment; Having to know the Persian languag; Non- pregnant women; Consent to participate in the study; Having a mobile phone with the ability to install applications; The ability to work with Mobile App; Lack of immune deficiency diseases; No underlying chronic disease; Exclusion criteria: Not wanting to continue participating in study; Failure to submit blood sugar for a week; Hospitalization
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 132
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
Ethics Committee of Shiraz University of Medical Sciences
Street address
Ethics Committee, Seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent Headquarters, Zand Ave., Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2016-09-25, 1395/07/04
Ethics committee reference number
IR.SUMS.REC.1395.110

Health conditions studied

1

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

Primary outcomes

1

Description
Glycosylated hemoglobin
Timepoint
Before intervention, three months after intervention
Method of measurement
Blood test

2

Description
Life style
Timepoint
Before intervention, three months after intervention
Method of measurement
Life style Questionnaire

Secondary outcomes

1

Description
Body mass index
Timepoint
Before intervention, three months after intervention
Method of measurement
Weight (kg)/ height (m)2

2

Description
Blood Pressure
Timepoint
Before intervention, three months after intervention
Method of measurement
Sphygmomanometer

Intervention groups

1

Description
In the experimental group using the software that is installed on their mobile phone, learning about diabetes, exercise, nutrition, foot care, diabetes and prevent complications they are given. Patients can also have your insulin levels and blood sugar in the application record.
Category
Lifestyle

2

Description
The control group receives routine care.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes clinic of Motahari Clini
Full name of responsible person
Tahereh Pakfetrat
Street address
Diabetes Clinic,Shahid Motahari Clinic, Namazi Square
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Shiraz University of Medical Science
Full name of responsible person
Dr. Seyed Basir Hashemi
Street address
Vice chancellor for research, seventh floor, Shiraz University of Medical Sciences, next to the Red Crescent headquarters, Zand Ave., Shiraz
City
Shiraz
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, Shiraz University of Medical Science
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
Shiraz University of Medical Science,Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Dr. Zahra Molazem
Position
PhD, Associate professor of nursing education
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
+98 36474252
Email
molazem@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Science, Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Dr. Zahra Molazem
Position
PhD, associate professor of nursing education
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City
Shiraz
Postal code
71936 -13119
Phone
+98 71 3647 4254
Fax
+98 71 3647 4252
Email
molazem@sums.ac.ir
Web page address
nurs-midwif.sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Science,Shiraz Hazrate Fatemeh Nursing and Midwifery college
Full name of responsible person
Zahra Jalali
Position
Nursing Graduate Student
Other areas of specialty/work
Street address
Hazrate Fatemeh Nursing and Midwifery college, Namazi Square, Shiraz.
City
Shiraz
Postal code
71936-13119
Phone
+98 71 3647 4254
Fax
Email
stud5479756036@sums.ac.ir; malihej@ymail.com
Web page address
nurs-midwif.sums.ac.ir

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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