Protocol summary

Study aim
Effects of Education on Self-care Improvement.
Design
In this research, 60 eligible patients referring to diabetic foot ulcer Association were chosen purposefully and were randomly divided into two groups of control and intervention. Group allocation was concealed by assigning a unique code to each participants.
Settings and conduct
This study was conducted at the health centers of Gonbade-Kavoos using educational sessions and a questionnaire.
Participants/Inclusion and exclusion criteria
Diabetes type2 diabetic foot -disaffiliation tow absentee in class
Intervention groups
In the intervention group, after 8 weeks of training, the questionnaire was completed, but in the control group only the usual training was done and the questionnaire was completed.
Main outcome variables
Empowering patients and carers-Understanding the needs of patients

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20140429017491N1
Registration date: 2018-01-22, 1396/11/02
Registration timing: retrospective

Last update: 2018-01-22, 1396/11/02
Update count: 0
Registration date
2018-01-22, 1396/11/02
Registrant information
Name
nadereh naderiravesh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 88465512
Email address
n.naderiravesh@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-20, 1395/06/30
Expected recruitment end date
2016-12-18, 1395/09/28
Actual recruitment start date
2016-09-20, 1395/06/30
Actual recruitment end date
2016-11-28, 1395/09/08
Trial completion date
empty
Scientific title
Effects of Education on Self-care Improvement of Diabetic foot Patient.
Public title
Effects of Education on Self-care Improvement.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diabetes Type2 Diabetic Foot
Exclusion criteria:
Disaffiliation Tow Absentee in Class
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Actual sample size reached: 60
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
According to the entrance and exit conditions, samples were selected.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Intersection of nyaesh ,Valiasr Avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1631675619
Approval date
2016-01-19, 1394/10/29
Ethics committee reference number
1394.267IR.SBMU.PHNM

Health conditions studied

1

Description of health condition studied
Diabetes Type2 Diabetic Foot
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
The effect of nursing education on self-care in the diabetic foot
Timepoint
After 8 weeks of training
Method of measurement
Self-care questionnaire for patients with diabetes

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group saw eight weeks of self-care education based on Orumi's theory.
Category
Lifestyle

2

Description
Control group: The control group was under the normal training of the health center.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes clinics, Khatam Al-Anbia Hospital Gonbad-e Qabus
Full name of responsible person
Gholamreza Nobaghi
Street address
Golestan Province - Gonbad Kavoos Town - Road Sayyad Shirazi
City
Gonbad-e Qabus
Province
Golestan
Postal code
1631675619
Phone
+98 17 8846 5512
Fax
+98 17 3338 6060
Email
nobaghi49@yahoo.com

2

Recruitment center
Name of recruitment center
Health Center Gonbad-e Qabus
Full name of responsible person
Gholamreza Nobaghi
Street address
استان گلستان -گنبدکاووس
City
Gonbad-e Qabus
Province
Golestan
Postal code
1631675619
Phone
+98 17 8846 5512
Fax
+98 17 3338 6060
Email
nobaghi49@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
هزینه شخصی
Full name of responsible person
Gholamreza Nobaghi
Street address
Golestan-Gonbad-Kavoos
City
Gonbad-Kavoos
Province
Golestan
Postal code
1631675619
Phone
+98 17 8846 5512
Fax
+98 17 3338 6060
Email
nobaghi49@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
personal expenses
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gholamreza Nobaghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan-Gonbad-Kavoos
City
Gonbad-Kavoos
Province
Golestan
Postal code
1631675619
Phone
+98 17 8846 5512
Fax
+98 17 3338 6060
Email
nobaghi49@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gholamreza Nobaghi
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan-Gonbad-Kavoos
City
Gonbad-Kavoos
Province
Golestan
Postal code
1631675619
Phone
+98 17 8846 5512
Fax
+98 17 3338 6060
Email
nobaghi49@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Gholamreza Nobaghi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Golestan-Gonbad-Kavoos
City
Golestan
Province
Golestan
Postal code
1631675619
Phone
+98 17 8846 5512
Fax
+98 17 3338 6060
Email
nobaghi49@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
(IPD):A portion of the data is shared, such as information on the main consequences
When the data will become available and for how long
(IPD):One year after the publication of the results
To whom data/document is available
(IPD):For researchers working in academic and scientific institutions and industry professionals
Under which criteria data/document could be used
(IPD):Use for research work in nursing education
From where data/document is obtainable
(IPD):Email the above email.nobaghi49@yahoo.com
What processes are involved for a request to access data/document
(IPD):With full introduction and giving your corporate address and address within a month, information is available
Comments
(IPD):In order to improve the health and awareness of the patients, the necessary cooperation will be provided in all areas of the research.
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