Protocol summary

Summary
Diabetes is one the most important health problems and common chronic metabolic disease that its side-effect is considered as a leading cause of mortality and morbidity. Self-efficacy has a key role in the successful self- management among diabetes patients. The current study will aim to study the educational intervention effect based on the self-efficacy theory on diabetes management among patients who will attain in diabetes clinic of Ale Jalil hospitals in Aq Qala city. A quasi-experimental survey will conduct in two groups that 60 patients will recruit to study and randomly allocate into case and control groups. Data will gather using Sherer General Self-Efficacy scale, Diabetes Management Self-Efficacy Scale as well as some of demographic variables. Educational intervention will implement based on the self-efficacy theory in three sessions (90 minutes for each one) during three weeks. Two months later post test will conduct. The diabetes care plans will be considered if its effectiveness confirm.

General information

Acronym
sef efficacy, diabet managment self efficacy schale
IRCT registration information
IRCT registration number: IRCT2015060622574N1
Registration date: 2015-07-13, 1394/04/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-07-13, 1394/04/22
Registrant information
Name
Hajar Dehghan
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 17 3452 5547
Email address
ha.dehghan@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University Social Welfare and Rehabilitation Science
Expected recruitment start date
2015-08-30, 1394/06/08
Expected recruitment end date
2015-09-16, 1394/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of education based on Social Cognitive Theory of Bandura on Diabet Management Self-Efficacy in diabetic patients
Public title
Effect of education based on Social Cognitive Theory of Bandura on Diabet Management Self-Efficacy in diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria were as follow: diagnosis of type 2 diabetes at least one year prior to the survey; lack of other chronic diseases except for diseases related to diabetes complications confirmed by a doctor; inclined to participate in research and having a record in diabetes clinics in Aq Qala city; no participation in previous study the same as the current study; aged between 35 to 70 years. An exclusion criterion was the experience the acute complications associated with diabetes during the study.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 58
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
University of Social Welfare and Rehabilitation Science
Street address
Koodakiar Avenue, Velenjal, Evin
City
Tehran
Postal code
Approval date
2014-10-26, 1393/08/04
Ethics committee reference number
uswr.rec.1393.174

Health conditions studied

1

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

Primary outcomes

1

Description
general self efficacy
Timepoint
before intervention, 2 month after interventin
Method of measurement
genera self efficacy schale

2

Description
diabet management slf efficacy
Timepoint
before intervention, 2 month after interventin
Method of measurement
diabet management slf efficacy schale

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group will divide into three groups that they will receive three sessions of education based on Banduras Social Learning Theory. Each session will take 90 minutes.
Category
Lifestyle

2

Description
The control group will not receive intervention and will only be provided by public care of diabetes clinic.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Ale Jalil Hospital
Full name of responsible person
Seid Mehdi Aqapour
Street address
Bandar Turkmen Road
City
Aq Qala

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Science
Full name of responsible person
Hamid Reza Khankeh
Street address
Koodakiar Avenue, Velenjak, Evin
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Science
Full name of responsible person
Farahnaz Mohammadi
Position
Associate Professor
Other areas of specialty/work
Street address
Koodakiar Avenue, Velenjak, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0013
Fax
Email
f_mohammadi_2000@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Science
Full name of responsible person
Hamid Reza Khanke
Position
Post Doc of Disaster
Other areas of specialty/work
Street address
Koodakiar avenue, Velenjak, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0036
Fax
Email
hamid.khankeh@ki.se
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Science
Full name of responsible person
Hamid Reza Khankeh
Position
Research Assistance
Other areas of specialty/work
Street address
Koodakiar Avenue, Velenjak, Evin
City
Tehran
Postal code
Phone
+98 21 2218 0013
Fax
Email
hamid.khankeh@ki.se
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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