Protocol summary

Summary
This study is designed to investigate the effect of self - care education on HBA1C and emotional intelligence of type II diabetic patients referred to martyr Motahari diabetic clinic in the year 2014. Patients 18 to 60 years old with at least a high school education who are living in Shiraz and refer to the center for follow-up treatment and with their informed consent selected . After filling out the consent form and demographic and Bar- on questionnaire and testing HBA1C by Using a randomized block divided into two experimental and control groups. Group received training materials once a week for 8 sessions for 1 - 1/5 hours. Control group not receiving intervention. Immediately after the intervention and two months after that date HBA1C test will be taken from both groups and Bar-on questionnaires filled out by their.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201408188505N7
Registration date: 2014-11-18, 1393/08/27
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-11-18, 1393/08/27
Registrant information
Name
Seyed Saeed Najafi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1727 7445
Email address
najafisa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-07-15, 1393/04/24
Expected recruitment end date
2015-11-14, 1394/08/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of self-care education on HBA1C and emotional intelligence of patients with type two diabetes
Public title
Effects of self-care education on HBA1C and emotional intelligence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Patient with type two; age between 18 - 60; having at least a high school diploma; willingness to participate in research; access to telephone; resident of Shiraz; without having mental or cognitive disorders Exclusion criteria: DKA; HHNS; catch to sever or life threatening disorder
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Central building of Shiraz University of Medical Sciences, Zand street, Shiraz
City
Shiraz
Postal code
71345-1978
Approval date
2014-07-14, 1393/04/23
Ethics committee reference number
ct-93-7091

Health conditions studied

1

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

Primary outcomes

1

Description
HBA1C
Timepoint
Before intervention; two months after stare of the intervention; two months after the end of intervention
Method of measurement
Percent scale, Blood sampling, With HPLC

2

Description
Emotional intelligence
Timepoint
Before intervention; two months after stare of the intervention; two months after the end of intervention
Method of measurement
Bar-on questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The control group had no intervention
Category
N/A

2

Description
Form 8-course training class once a week for 1- 1/5 hours for the intervention group
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes clinic martyr Motahari
Full name of responsible person
Masoume Tohidi
Street address
Second floor of Martyr Motahari Clinic, Namazi square, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Shiraz University of Medical Sciences
Full name of responsible person
Dr. Sayed Basir Hashemi
Street address
Seventh floor of Shiraz university of Medical Sciences and health services, Zand blvd
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 of Shiraz 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
Shiraz university of medical sciences
Full name of responsible person
Salma Tavakol Moghadam
Position
master of nursing
Other areas of specialty/work
Street address
Hazrat-e-Fateme nursing and midwifery college, Namazi hospital, Namazi square
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3212 2633
Fax
+98 71 3212 2430
Email
salinavid@yahoo.com; salma.Tmoghadam@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Syed Saeed Najafi
Position
MS in nursing - Faculty
Other areas of specialty/work
Street address
Hazrat-e-Fateme nursing and midwifery college, Namazi hospital, Namazi square
City
Shiraz
Postal code
71345-1978
Phone
+98 71 3212 2633
Fax
+98 32122430
Email
s_najafi44@yahoo.com ; najafisa@sums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Syed Saeed Najafi
Position
MS in nursing
Other areas of specialty/work
Street address
No. 1132, street 23/1, valiasr town, Rahmat blvd
City
Shiraz
Postal code
7156834939
Phone
+98 713727445
Fax
+98 71 3647 4252
Email
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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