Protocol summary

Summary
Aim: The purpose of this experimental study was to determine the effect of tele-education by telephone and short message service on laboratory parameters in type 2 diabetic patients who refer to Urmia Diabetes Association. Method: In this research 66 type 2 diabetic patients were selected by convenience sampling and then were divided into two groups randomly; control group (n=33) and intervention group (n=33). Inclusion criteria: being able to read and write, age (18-55 years old), being satisfied to participate in the study (intervention or control group), diabetes of these patients has been confirmed by specialist and having mobile phone. Exclusion criteria: Patients with secondary problems such as a history of mental illness, high blood pressure and chronic renal disease, heart disease, and illiterate. Before and after the study, Information about individual characteristics was collected by questionnaire and blood sample was drawn for fasting blood sugar, cholesterol, Triglyceride, Glycosylated Hemoglobin and fasting Insulin in both groups. The control group was received Diabetes Association routine education and the intervention group was received education and follow up by telephone and short message service for 3 months. The control group was received educational package after the study as well.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013111215390N1
Registration date: 2014-01-24, 1392/11/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-01-24, 1392/11/04
Registrant information
Name
Naser Parizad
Name of organization / entity
Urmia University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 44 1348 7649
Email address
parizad.n@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Urmia University of Medical Sciences.
Expected recruitment start date
2011-08-23, 1390/06/01
Expected recruitment end date
2011-09-21, 1390/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of tele-education by telephone and short message service on Laboratory parameters in type 2 diabetic patients who refer to Urmia Diabetes Association in 2011
Public title
The effect of tele-education on Laboratory parameters of patients with type 2 diabetes
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria: Being able to read and write, age (18-55 years old), being satisfied to participate in the study , diabetes of these patients has been confirmed by specialist and having mobile phone. Exclusion criteria: Patients with secondary problems such as a history of mental illness, high blood pressure and chronic renal disease, heart disease, and illiterate
Age
From 18 years old to 55 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 66
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For sampling, initially a sampling frame of patients who met inclusion criteria have been provided, then by using random number table 66 patients were selected randomly among them. Then the patients allocated in two intervention and control groups.

Secondary Ids

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Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Urmia University of Medical Sciences
Street address
Jahad Ave., Resalat Blvd., Urmia, Iran
City
Urmia
Postal code
5714783734
Approval date
2013-12-03, 1392/09/12
Ethics committee reference number
umsu.rec.1392.167

Health conditions studied

1

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

Primary outcomes

1

Description
Fasting Blood Sugar
Timepoint
Before the intervention and three months after the intervention
Method of measurement
By Enzymatic method (mg/dl)

2

Description
Cholesterol
Timepoint
Before the intervention and three months after the intervention
Method of measurement
By Enzymatic method (mg/dl)

3

Description
The glycosylated hemoglobin
Timepoint
Before the intervention, and three months after intervention
Method of measurement
By Calories metric method (mg/dl)

4

Description
Insulin serum
Timepoint
Before the intervention, and three months after the intervention
Method of measurement
By Elisa Method (ng/mL)

Secondary outcomes

empty

Intervention groups

1

Description
Education by Telephone intervention was carried out for three months. In this case, telephone calls for follow up and education were established by the researcher for every participant twice a week. The time for Telephone calls was determined between 8 Am to 10 Pm with the agreement of the patients. The average call duration was considered about 20 minutes. The content of telephone conversations, including the assessment of glycemic control status in the field of diet, exercise, blood glucose self-monitoring and medication. And if there is a failure of glycemic control, the situation analyzed with participants’ help to find the problem, eventually providing suggested solution to the patient for solving the problem and answering patient questions. In education by mobile phone (SMS) messages regarding the self-care education (diet, exercise, self-monitoring of blood glucose, foot care and medication) was sent. Every day, a message was sent to participants, so that in three months, 90 text messages were sent.
Category
Lifestyle

2

Description
No intervention carried out in control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Urmia Diabetes Association
Full name of responsible person
Dr.Hamid Asgharzadeh
Street address
No. 269, Nobovvat bridge, Shahar Chai, Urmia
City
Urmia

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Urmia University of Medical Sciences
Full name of responsible person
Dr.Morteza Motazaker
Street address
Jahad Ave., Resalat Blvd., Urmia, Iran
City
Urmia
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, Urmia 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
Nursing and Midwifery faculty
Full name of responsible person
Naser Parizad
Position
Instructor/MScN
Other areas of specialty/work
Street address
11th kilometer of Sero Road, Nazloo Pardis, Urmia
City
Urmia
Postal code
5756115111
Phone
+98 44 1275 4964
Fax
Email
parizad.n@umsu.ac.ir
Web page address
http://nm.umsu.ac.ir/

Person responsible for scientific inquiries

Contact
Name of organization / entity
Urmia Nursing and Midwifery Faculty
Full name of responsible person
Dr.Masumeh Hemmati Maslakpak
Position
Assistant Professor/Ph.D
Other areas of specialty/work
Street address
11th kilometer of Sero Road, Nazloo Pardis, Urmia
City
Urmia
Postal code
5756115111
Phone
+98 44 1275 4963
Fax
+98 44 1275 4913
Email
hemmati_m@umsu.ac.ir
Web page address
http://nm.umsu.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Urmia Nursing and Midwifery Faculty
Full name of responsible person
Naser Parizad
Position
Instructor/ MScN
Other areas of specialty/work
Street address
11th kilometer of Sero Road, Nazloo Pardis, Urmia
City
Urmia
Postal code
5756115111
Phone
+98 44 1275 4964
Fax
+98 44 1275 4913
Email
parizad.n@umsu.ac.ir
Web page address
http://nm.umsu.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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