Protocol summary

Summary
This study aimed to assess the effect of education by health care provider and peer on self-care behaviors and HbA1C in diabetic patients. In this randomized controlled trial, 120 patients will select and randomly allocate into three groups of education by health care provider, education by peer and control. In the intervention group by health care provider, patients will receive health and self- care education in the field of diabetes by health care provider and in the intervention group by peer, patients will receive this education by peer. In the control group, patient will receive usual education in accordance with normal procedures of the diabetes center. Study instruments include a questionnaire for demographic variables and self-care behaviors (SDSCA) questionnaire and a sheet for record of HBA1C. Data will collect at baseline and 12 weeks after the intervention. Data analysis will done using descriptive and analytic statistics tests.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015122223190N1
Registration date: 2016-02-11, 1394/11/22
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-02-11, 1394/11/22
Registrant information
Name
Tabandeh Sadeghi
Name of organization / entity
Rafsanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 34 3425 5900
Email address
t.sadeghi@rums.ac.ir
Recruitment status
Recruitment complete
Funding source
Rafsanjan University of Medical Sciences
Expected recruitment start date
2015-12-26, 1394/10/05
Expected recruitment end date
2016-04-02, 1395/01/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative assessment the effect of education by health care provider and peer on self-care behaviors and HbA1C in diabetic patients referred to diabetes clinic in Bandar Abbas 2015
Public title
Effect of education by health care provider and peer on diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: live in bandarabbas; Age between 40-65; Type 2 diabetes; No other disease; Informed consent; Exclusion criteria: Not wanting to collaborate for research; Certain other diseases
Age
From 40 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 120
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
Ethic Committe of Rafsanjan University of Medical Sciences
Street address
Emam Ali Street, Organizatin Center of Rafsanjan University of Medical Sciences, Rafsanjan
City
Rrafsanjan
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
31.20.953

Health conditions studied

1

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

Primary outcomes

1

Description
HBA1C
Timepoint
before intervention and 3 months after intervention
Method of measurement
Hemotology test by spectrofotometr

2

Description
Self care behavior
Timepoint
before intervention and 3 months after intervention
Method of measurement
questionnaire SDSCA

Secondary outcomes

empty

Intervention groups

1

Description
In the intervention group by health care provider, patients will receive health and self- care education in the field of diabetes by health care provider for 12 week
Category
Lifestyle

2

Description
In the control group, patient will receive usual education in accordance with normal procedures of the diabetes center for 12 week.
Category
Treatment - Drugs

3

Description
In the intervention group by peer, patients will receive health and self- care education in the field of diabetes by peer for 12 week
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes clinic in Bandar Abbas
Full name of responsible person
Zakieh Ahmadi
Street address
plaque27, Pune Alley, shohada street , Bandar Abbas
City
Bandar Abbas

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Mohamadreza Mirzaee
Street address
Rrafsanjan, Organization Center of Rafsanjan University of Medical Sciences
City
Rafsanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rafsanjan 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
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Nursing PHD, Assistant professor
Other areas of specialty/work
Street address
Jomhouri street, Nursing and Miwifery School, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir, t.b_sadeghi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Nursing PhD. Assisstant professor
Other areas of specialty/work
Street address
Jomhouri street، Nursing and Midwifery School, Rafsanjan
City
Rafsanjan
Postal code
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir, t.b_sadeghi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Rafsanjan University of Medical Sciences
Full name of responsible person
Tabandeh Sadeghi
Position
Nursing PHD, Assistant professor
Other areas of specialty/work
Street address
Jomhouri Street, Nursing and Midwifery School, Rafsanjan
City
Rafsanjan
Postal code
7718796755
Phone
+98 34 3425 5900
Fax
Email
t.sadeghi@rums.ac.ir
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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