Protocol summary

Summary
Objectives: This research intends to evaluate the effect of peer support on self efficacy level in type II diabetics. Peer support can link people sharing experiences to provide the practical, emotional, and ongoing support to control patients’ sustained behavior changes. Design: This study is a randomized clinical trial with pretest - posttest and control group. Methods: A convenient sample of 80 patients with diabetes are selected from the diabetes clinic Shahid Choobkar in Chamran Hospital, A branch of Lorestan University of Medical Sciences. These people who have the required conditions to participate in the study, The group was divided randomly into two equal groups of 40 persons (experimental and control). The major eligibility criteria: They include the age (above 30), a primary literacy, the lack of physical limitations for self-care. with a medical profile in the diabetes clinic, having a history of diabetes type 2 at least for one year, having sufficient time to participle in the group sessions. The major outcome criteria: The Lack of mental health and physical health relating to the age that may hinder the learning, such as memory problems, Alzheimer's, etc. The use of the medicines that affect the consciousness and learning levels. The affection to other known chronic diseases such as kidney, autoimmunization diseases etc. Based on the patients’ own statements, medical and paramedical educations, the intention of immigration during the study and the background of similar study participation. Interventions: After preparing peers, the participants in the intervention group in the selected center was supported by their peers in face to face meetings for 3 following months (10 sessions of 2 hours) whit Instructional content is defined in relation to the identification diabetes, types of diabetes, risk factors, complications, treatment and control, the role of diet, exercise, Self-monitoring of blood glucose and medications to control diabetes by group discussions, asking and answering sessions and sharing their personal experiences and success on the diabetes disease control. In the end of the period, the pedagogical pamphlets Was presented to the group, whereas the control group received only routine care(such as the periodical doctor visits and pedagogical classes...). The main outcome: Self efficacy level in both intervention and control groups was measured before and three months after the intervention.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013080712974N2
Registration date: 2014-08-26, 1393/06/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2014-08-26, 1393/06/04
Registrant information
Name
Kobra Rashidi
Name of organization / entity
Lorestan University of Medical Sciences (School of Nursing Boroujerd
Country
Iran (Islamic Republic of)
Phone
+98 66 2446 7452
Email address
krashidi2010@yahoo.com
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research, Tehran Islamic Azad University of Medical Sciences
Expected recruitment start date
2013-06-22, 1392/04/01
Expected recruitment end date
2013-07-21, 1392/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study effect of the peer support on self efficacy level in type II diabetic patients
Public title
The effect peer support in the diabetes control Public title : The effect peer support in the diabetes control
Purpose
Supportive
Inclusion/Exclusion criteria
The major eligibility criteria: They include the age (above 30); a primary literacy; the lack of physical limitations for self-care. With a medical profile in the diabetes clinic; having a history of diabetes type 2 at least for one year; having sufficient time to participle in the group sessions.The major outcome criteria: The Lack of mental health and physical health relating to the age that may hinder the learning; such as memory problems; Alzheimer's; etc. The use of the medicines that affect the consciousness and learning levels. The affection to other known chronic diseases such as kidney; autoimmunization diseases; etc. Based on the patients’ own statements; medical and paramedical educations; the intention of immigration during the study and the background of similar study participation.
Age
From 30 days old to 75 years old
Gender
Both
Phase
2-3
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 Tehran Islamic Azad University of Medical Sciences
Street address
Khaghani Street, Shariati Street, Tehran Islamic Azad University of Medical Sciences,Tehran
City
Tehran
Postal code
193951495
Approval date
2013-01-22, 1391/11/03
Ethics committee reference number
91/2337

Health conditions studied

1

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

Primary outcomes

1

Description
Self efficacy level
Timepoint
Before the intervention, three months after the intervention
Method of measurement
DMSES questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
After preparing peers, the participants in the intervention group in the selected center were supported by their peers in face to face meetings for 3 following months (10 sessions of 2 hours) whit instructional content is defined in relation to the identification diabetes, types of diabetes, risk factors, complications, treatment and control, the role of diet, exercise, Self-monitoring of blood glucose and medications to control diabetes by group discussions, asking and answering sessions and sharing their personal experiences and success on the diabetes disease control. In the end of the period, the pedagogical pamphlets Was presented to the group.
Category
Other

2

Description
The control group received only routine care (such as the periodical doctor visits and pedagogical classes).
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Clinic Shahid Choobkar in Chamran Hospital, Lorestan University of Medical Sciences
Full name of responsible person
Soleimani Fateme
Street address
Iran
City
Boroujerd

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research, Tehran Islamic Azad University of Medical Sciences
Full name of responsible person
Hejazy Zohre
Street address
Khaghani Street, Shariati Street, Tehran Islamic Azad University of Medical Sciences, Tehran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research, Tehran Islamic Azad 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
Lorestan University of Medical Sciences (School of Nursing Boroujerd)
Full name of responsible person
Rashidi Kobra
Position
Master of Nursing - Lecturer
Other areas of specialty/work
Street address
Shariati Street, School of Nursing, Boroujerd
City
Boroujerd
Postal code
Phone
+98 66 2446 7452
Fax
Email
krashidi2010@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Lorestan University of Medical Sciences (School of Nursing Boroujerd)
Full name of responsible person
Rashidi Kobra
Position
Master of Nursing - Lecturer
Other areas of specialty/work
Street address
Shariati Street, School of Nursing, Boroujerd
City
Boroujerd
Postal code
Phone
+98 66 2446 7452
Fax
Email
krashidi2010@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Lorestan University of Medical Sciences (School of Nursing Boroujerd)
Full name of responsible person
Rashidi Kobra
Position
Master of Nursing - Lecturer
Other areas of specialty/work
Street address
Shariati Street, School of Nursing, Boroujerd
City
Boroujerd
Postal code
Phone
+98 66 2446 7452
Fax
Email
Krashidi2010@yahoo.com
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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