Protocol summary

Summary
In this study we want to show that educational intervention based on locus of control structure in attribution theory has influence on self-care behavior in type II diabetics. Inclusion criteria is having membership of the Diabetes Association of Babol and being diagnosed with diabetes. Exclusion criteria of this study is, lack of willingness to participate in any time of the study 180 people, in two groups of people in a interventional study will be answer to C multidimensional health locus of control scale and activity scale diabetes self-care form. We expect to see an increase in the mean score of self-care and score of internal locus of control and reduction in the mean score of external locus of control and chance locus of control two months after intervention.

General information

Acronym
Have not
IRCT registration information
IRCT registration number: IRCT2015053122500N1
Registration date: 2015-06-22, 1394/04/01
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-06-22, 1394/04/01
Registrant information
Name
Farbod Ebadi Fard Azar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8861 0120
Email address
ebadi.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Provided by Iran University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-07-23, 1394/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on locus of control structure in attribution theory on self-care behavior in type II diabetics in Babol Diabetes Association.
Public title
The effect of education on diabetes self-care based on locus of control
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: having membership of the Diabetes Association of Babol; established diagnosed of diabetes Exclusion criteria: lack of willingness to participate at any time of the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 180
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
Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Between Junction of Sheikh Falollahe Noori & ShahidChamran, west Shahid Hemmat highway, Tehran
City
Tehran
Postal code
1449614535
Approval date
2015-02-07, 1393/11/18
Ethics committee reference number
93/د/105/5406

Health conditions studied

1

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

Primary outcomes

1

Description
locus of control
Timepoint
Two months after the intervention
Method of measurement
C form of MHLC questionnaire

Secondary outcomes

1

Description
self-care
Timepoint
Two months after intervention
Method of measurement
MHLC questionnaire

Intervention groups

1

Description
Control group: no intervention
Category
N/A

2

Description
Intervention group: three interventional training session for three hours during three weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Babol Diabetes Association
Full name of responsible person
Hassan Heydari
Street address
No. 3, komeil.10, Pasdaran.4, Velayat square, Taleghani avenue, Babol, Mazandaran
City
Babol

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr.Seyed Ali Javad Moosavi
Street address
Iran University of Medical Sciences, Between Junction of Sheikh Falollahe Noori & Shahid Chamran, west Shahid Hemmat highway, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Farbod Ebadi Fard Azar
Position
Health Care Management Ph.D
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Between Junction of Sheikh Falollahe Noori & Shahid Chamran, west Shahid Hemmat highway, Tehran
City
Tehran
Postal code
1449614535
Phone
+98 21 8861 0120
Fax
+98 21 8861 0122
Email
dr_febadi@yahoo.com
Web page address
iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farbod Ebadi Fard Azar
Position
Health Care Management Ph.D
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Between Junction of Sheikh Falollahe Noori & Shahid Chamran, west Shahid Hemmat highway, Tehran
City
Tehran
Postal code
1449614535
Phone
+98 21 8861 0120
Fax
+98 982188610122
Email
dr_febadi@yahoo.com
Web page address
iums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Farbod Ebadi Fard Azar
Position
Health Care Management Ph.D
Other areas of specialty/work
Street address
Iran University of Medical Sciences, Between Junction of Sheikh Falollahe Noori & Shahid Chamran, west Shahid Hemmat highway, Tehran
City
Tehran
Postal code
1449614535
Phone
+98 21 8861 0120
Fax
+98 21 8861 0122
Email
dr_febadi@yahoo.com
Web page address
iums.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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