Protocol summary

Summary
This study will have been perform on all Patients with insulin-dependent diabetes who will referred to the emergency department and clinic of Sina Hospital in Tabriz (80 patients) and randomly divide into two groups: face to face training and in-service training. HgA1C will measure before and after 3 months of training and complete on self-care checklist before training and three months after training. The face to face training group received 2 hours of self-care training, nutrition, foot care, injection of insulin and its care And in the short message group, they were given the same materials by telegram and texting for three months. During the study, the fasting blood glucose level was measured and recorded by the patients themselves each day on a specified day. Data were analyzed using SPSS software and multivariate analysis of variance MANOVA, paired and independent t-test.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060125316N4
Registration date: 2017-07-31, 1396/05/09
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-31, 1396/05/09
Registrant information
Name
Hossein Feizollahzadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3477 0649
Email address
feizollahzadehh@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences, Vice-chancellor in Research Affairs
Expected recruitment start date
2017-08-13, 1396/05/22
Expected recruitment end date
2017-11-13, 1396/08/22
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of face to face training and multimedia short message on Self-care, HbA1C and FBS of patients with type I diabetes
Public title
The effect of face to face training and multimedia short message on Self-care, HbA1C and FBS of patients with type I diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Criteria for entering the study 1) age over 16 year 2) Patients with insulin-dependent diabetes 3) Not having severe heart disease, kidney disease 4) Lack of admission due to ketoacidosis and HHNS 5) Lack of visual impairment and hearing loss and cognitive impairment 6) A resident of Tabriz or villages near Tabriz 7) Acquire informed consent of the participants 8) Having a mobile phone that has a telegram and SMS program 9) Having reading and writing skills 10) Interested in using a telegram Exit criteria 1) Hospitalization for any reason 2) Travel to distant destinations of the researche Exit criteria: 1) Hospitalization for any reason 2) Travel to distant destinations of the researcher
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz / Azadi Avenue / Golgast Street / Central Office of the University of Medical Sciences
City
Tabriz
Postal code
Approval date
2017-07-03, 1396/04/12
Ethics committee reference number
IR.TBZMED.REC.1396.269

Health conditions studied

1

Description of health condition studied
DIABET
ICD-10 code
E10
ICD-10 code description
E10

Primary outcomes

1

Description
FBS
Timepoint
Three months every week on Friday
Method of measurement
Glucometer

2

Description
HbA1C
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Calorimetric Laboratory

3

Description
Self-care
Timepoint
Before the intervention, three months after the intervention
Method of measurement
Toobert and Glasgow self-care questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In a face-to-face group of 40, one day, a 2-hour session will be held by the researcher at the General Hall of Sina Hospital for self-care education, in which the proper education of the diet, how to care for the feet of self-care, self-care Monitoring, how to use medications. At the beginning of the session, you will get acquainted with diabetes, its complications, the ways to prevent it, and then exercise, how to control your blood sugar, the right diet, how to use prescription drugs, including oral and insulin therapy hours, sites Injection of insulin and how to adjust the amount, self-care education is provided to patients. It should be noted that during the training session, the lecture will be used along with the video projector and relevant brochure.
Category
Lifestyle

2

Description
In the intervention group( multimedia short massage via telegram) group (40 people), the participant's mobile number or his close relatives (who received the job and The correct transfer of the message to the participant will be received from him) will be received. Mobile phone in terms of acceptance SMS messages and the availability of the telegram are checked. If there is no dialer, the program will be installed on nearby handsets or participants. During the 3 months the researcher trained during the weekly two times on Saturdays and Tuesdays at 10 am Different types of diets, exercise, foot care, ways to prevent it, how to control your blood sugar, correct diet, how to use prescription drugs, including insulin infusion hours, insulin injection sites and how to adjust it, and Self-care education will be sent to the participants via SMS. A telegram channel will also be created by the researcher, during which the 3-hour texting sent by short message of the same week will be sent to reminders with short video and screenshots by participants on Sundays, Mondays, Wednesdays, and Thursdays 10 am will be received.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Hossein feizollahzadeh
Street address
Faculty of Nursing and Midwifery, south Shariati Ave.
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Tabriz University of Medical Sciences
Full name of responsible person
Dr Mohammad Reza Rashidi
Street address
Vice Chancellor for research of Tabriz University of Medical Sciences
City
Tabriz
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 Tabriz University of Medical Sciences
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
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Feizollahzadeh
Position
Academic Member/ PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Ave.
City
TABRIZ
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
feizollahzadehh@tbzmed.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Feizollahzadeh
Position
Academic Member/ PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Ave.
City
tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
feizollahzadehh@tbzmed.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Hossein Feizollahzadeh
Position
Academic Member/ PhD
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, South Shariati Ave.
City
tabriz
Postal code
5138947977
Phone
+98 41 3479 6770
Fax
Email
feizollahzadehh@tbzmed.ac.ir
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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