Protocol summary

Summary
The aims of this clinical trial study is determination the effects of peer education on self-efficacy and quality of life in patients with type II diabetes.The target population of the study are all patients admitted to endocrine ward of Firoozgar hospital. All patient should have at least six months established type II diabetes. Sample size are 70 patients. Sampling is a simple random method and then patients will divide in two groups of case and control based on block randomization method. Some of the inclusion criteria of study are: patients with at least six month established type II diabetes, age between 21-75 years and lack of participation in other training program about diabetes during last six months. Some of the exclusion criteria including: patients with cognitive disorders, physical disability, medical and paramedical educations. Self efficacy and quality of life will measure before and after two months education.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201401079623N4
Registration date: 2014-01-16, 1392/10/26
Registration timing: prospective

Last update:
Update count: 0
Registration date
2014-01-16, 1392/10/26
Registrant information
Name
Morteza Shamsizadeh
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0535
Email address
shamsizadeh_m@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2014-01-17, 1392/10/27
Expected recruitment end date
2014-02-16, 1392/11/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of peer education on self-efficacy and quality of life in diabetic patients
Public title
Effects of peer education on self-efficacy and quality of life in diabetic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: • patients with established diabete type II for at least 6 month. • Patients with age between 21-75 years. • Consent for parcipitate in the study. • Patients dosent have any education about dibet durring past 6 months. • Ability to speak Persian. • Ability of reading and writing. • Patients without cognitive disorders, physical disability and medical education. • Able to be in direct or indirect communication with paients. Exclusion criteria: • Death of patients durring the study. • Patients without parcipitation in the study. • Patients in case group without parcipitatipn in any of educational session. • Development of a new physical problem in patient that make him/her to unable of self care.
Age
From 21 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
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
Tehran University of Medical Sciences
Street address
Qods street, Keshavarz Bolvar, Tehran
City
Tehran
Postal code
1419733171
Approval date
2014-01-06, 1392/10/16
Ethics committee reference number
130/2315/د/92

Health conditions studied

1

Description of health condition studied
diabete
ICD-10 code
E10,E11,E1
ICD-10 code description
Diabetes mellitus

Primary outcomes

1

Description
self efficacy
Timepoint
before educational session and two months after educational session
Method of measurement
DMSES questionnaire

2

Description
quality of life
Timepoint
before educational session and two months after
Method of measurement
QOL questionnaires,N.M. Alavi et al.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group, receives peer education
Category
Other

2

Description
Control groups, receives routine education
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Firoozgar Hospital
Full name of responsible person
Dr.aghili
Street address
Vali-e-Asr Sq, Karim Khan Zand Ave, behafarin street, Firoozgar Hospital.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Azam Bahiraei
Street address
Faculty of Nursing and Midwifery of Tehran, Tohid SQ, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Khavasi
Position
Master of Science Student
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, Tohid SQ, Tehran
City
Tehran
Postal code
1461614745
Phone
+98 21 6105 4121
Fax
Email
mkhavasi90@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Daryadokht Masrur Rudsari
Position
Iinstructor
Other areas of specialty/work
Street address
Vanak Square, Beginning Zafar St, Shahid  Yasemi St, School of Nursing and Midwifery Of Iran
City
Tehran
Postal code
Phone
+98 218888288
Fax
Email
Daryadokht_masror@yahoo com
Web page address
http://fnm.iums.ac.ir/

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Khavasi
Position
Master of Science in Nursing Student
Other areas of specialty/work
Street address
Tohid SQ, Tehran
City
Tehran
Postal code
1461614745
Phone
+98 21 6105 4121
Fax
Email
mkhavasi90@gmail.commkhavasi90@yahoo.com
Web page address
http://fnm.tums.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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