Protocol summary

Summary
This is a randomized controlled clinical trial. The aim of this research is to investigate the effect of educational program based on Health belief Model on diabetic (Type II) self efficacy. Participants for the study group are recruited from Iranian Diabetes society. Participants are randomly assigned into intervention or control group. The participants in the intervention group are trained in a 2 session educational program (each session 30 minutes) based on health belief model. We also give them a booklet. Self Efficacy is measured by using a questionnaire before the intervention and at the end of the course (2 months after intervention).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138811191693N4
Registration date: 2010-09-25, 1389/07/03
Registration timing: prospective

Last update:
Update count: 0
Registration date
2010-09-25, 1389/07/03
Registrant information
Name
Soghra Nikpour
Name of organization / entity
Center for Nursing Care Research, School of Nursing & Midwifery, Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8247 1308
Email address
s-nikpour@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Expected recruitment start date
2010-10-23, 1389/08/01
Expected recruitment end date
2011-05-22, 1390/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational program based on Health belief Model on diabetic (Type II) self efficacy in Iranian Diabetes society
Public title
The effect of educational program based on Health belief Model on diabetic (Type II) self efficacy in Iranian Diabetes society
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Having literacy, age 30-60 years, Having Telephone Exclusion criteria: having any formal learning class about diabetic (Type II), presence of any learning disorders or severe mental disorders
Age
From 30 years old to 70 years old
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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee in medical researches of School of Nursing & Midwifery, Iran University of Medical
Street address
Rashid Yasami St., Valiasr ave.Tehran, Po.BOX:19395.4798, Iran
City
Tehran
Postal code
19964
Approval date
2010-01-19, 1388/10/29
Ethics committee reference number
1536741

Health conditions studied

1

Description of health condition studied
self efficacy in Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus

Primary outcomes

1

Description
Self efficacy
Timepoint
2 months
Method of measurement
Using questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
2 session educational program (each session 30 minutes) based on health belief model. we also give them a booklet
Category
Lifestyle

2

Description
No intervention in Control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Diabetes society
Full name of responsible person
Dr Asadollah Rajab
Street address
No 26, Ramin Malekoti st., Patrislomomba st, Satarkhan St,Tehran, Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, Iran University of Medical Sciences
Full name of responsible person
Dr. sayyed Abbas Motevallian
Street address
Crossroad of Shahid Hemmat & Shahid Chamran Expressways. P.O.Box: Tehran
City
Tehran
Grant name
Grant code / Reference number
م ت/404
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, 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
Center for Nursing Care Research of Iran University of Medical Science
Full name of responsible person
Soghra Nikpour
Position
Assistant professor
Other areas of specialty/work
Street address
Center for Nursing Care Research, Iran University of Medical Sciences and Health Services, Nursing &Midwifery School, Opposite of KHATAM OL ANBIA Hospital , Rashid Yasami St.Valiasr ave.Tehran
City
Tehran
Postal code
19964
Phone
+98 21 8247 1308
Fax
+98 21 8879 3805
Email
s-nikpour@iums.ac.ir,nikiniki_s@yahoo.com
Web page address
www.iums.ac.ir/cncr

Person responsible for scientific inquiries

Contact
Name of organization / entity
Center for Nursing Care Research, Iran University of Medical Sciences
Full name of responsible person
Soghra Nikpour
Position
Assistant professor
Other areas of specialty/work
Street address
Center for Nursing Care Research of IUMS, Nursing &Midwifery, Iran University of medical Sciences (IUMS), Rashid Yasami St.Valiasr ave.Tehran
City
Tehran
Postal code
19964
Phone
+98 21 8247 1308
Fax
+98 21 8879 3805
Email
s-nikpour@iums.ac.ir,nikiniki_s@yahoo.com
Web page address
www.iums.ac.ir/cncr

Person responsible for updating data

Contact
Name of organization / entity
Center for Nursing Care Research, Iran University of Medical Sciences and Health Services
Full name of responsible person
Soghra Nikpour
Position
Assistant professor
Other areas of specialty/work
Street address
Center for Nursing Care Research, Iran University of Medical Sciences and Health Services, Nursing &Midwifery School, Opposite of KHATAM OL ANBIA Hospital , Rashid Yasami St.Valiasr ave.Tehran
City
Tehran
Postal code
19964
Phone
+98 21 8247 1308
Fax
+98 21 8879 3805
Email
s-nikpour@iums.ac.ir,nikiniki_s@yahoo.com
Web page address
www.iums.ac.ir/cncr

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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