Protocol summary

Summary
This study compared two methods of individual and group training on knowledge, performance and efficacy of foot care in patients with type 1 and 2 were performed.Qualified persons (physical and mental ability to participate in the study; having literate enough ability in foot care alone) randomly divided into two groups: individual and group training.Before the education of patients pre-test was taken.Each patient underwent three sessions once a week for three weeks were individual and group training.After education of patients post-test was taken.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201203086918N6
Registration date: 2012-05-05, 1391/02/16
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2012-05-05, 1391/02/16
Registrant information
Name
Alehe Seyedrasooli
Name of organization / entity
Faculty of Nursing & Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 41 1479 0365
Email address
seyyedrasooly@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for research, Tabriz University of Medical Sciences
Expected recruitment start date
2012-04-20, 1391/02/01
Expected recruitment end date
2012-09-20, 1391/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Group and Individual Teaching Methods on the Knowledge, Practice and Self-efficacy Regarding to Foot Care in Diabetic Patients
Public title
Diabetic Foot
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Having a diagnosis of diabetes1 & 2 to identify relevant; Having at least 18 years of age; Awareness of the diagnosis of diabetes; Mental and physical ability to participate in the study; Having just read and write; The ability of foot care alone; Lack of education, medical groups and engaging in health centers - health; Not pass any formal courses in caring foot background; Lack of diabetes in pregnancy Exclusion criteria: Failure to complete the training program during the implementation process;Receive any training programs during the study; People with diabetic foot
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
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

1

Registry name
در محلی ثبت نشده است
Secondary trial Id
Central Is Not Registered in Any
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Deputy of Tabriz University of Medical Sciences
City
Tabriz
Postal code
Approval date
2012-03-12, 1390/12/22
Ethics committee reference number
915

Health conditions studied

1

Description of health condition studied
Diabetes
ICD-10 code
E10-E14
ICD-10 code description
Diabetes Mellitus

Primary outcomes

1

Description
Knowledge
Timepoint
Before test and one mounth after test
Method of measurement
Knowledge Questionnaire

2

Description
Practic
Timepoint
Before test and one mounth after test
Method of measurement
Practic Questionnaire

3

Description
Self-efficacy
Timepoint
Before test and one mounth after test
Method of measurement
Self-efficacy Questionnaire

Secondary outcomes

1

Description
No
Timepoint
No
Method of measurement
No

Intervention groups

1

Description
Three sessions of training as a group once a week for three weeks during the 45 minutes offered
Category
Prevention

2

Description
Individual training three sessions once a week for three weeks during the 45 minutes offered
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Nader Kazemi Shiraz Health Center
Full name of responsible person
Dr.Safari
Street address
Valyasr Field, Pir Nia Bridge
City
shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of Tabriz University of Medical Sciences
Full name of responsible person
Dr.Rashidi
Street address
Shariety South St ; Faculty of Nursing & Midwifery of Tabriz ;
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of Tabriz 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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Faculty of Nursing & Midwifery of Tabriz
Full name of responsible person
Tayyebe izadi
Position
MS
Other areas of specialty/work
Street address
Shariety South St; Faculty of Nursing & Midwifery ; Tabriz ; Iran
City
Tabriz
Postal code
5138947977
Phone
+41 13820967
Fax
+98 41 1479 6969
Email
izadit@yahoo.com
Web page address

Person responsible for updating data

Contact

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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