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Empowerment of Type 2 Diabetic Patients Visiting Fuladshahr Diabetes Clinics for Prevention of Diabetic Foot

Protocol summary

Study aim
Empowerment of Type 2 Diabetic Patients Visiting Fuladshahr Diabetes Clinics for Prevention of Diabetic Foot
Design
Sample was selected through block randomized foursome groups according to the sample size; subsequently, the sample was divided into two experiment and control groups. The number of subjects in each group was 46; then, considering about 11% sample loss (based on calculations), in the second stage, the sample size for each group was calculated to be 52.
Settings and conduct
Considering the sample’s size and the necessity of grouping the subjects in order to reach more efficacy, the patients were divided into four groups of 13. The duration of each session was about 40-50 minutes. For each of the subgroups, four sessions of empowerment were held on a weekly and regular basis. According to this program, empowerment should be carried out in four steps which are presented in this study in four sessions.
Participants/Inclusion and exclusion criteria
Inclusion:Having type 2 diabetes based on diagnosis of an endocrinologist, Absence of diabetic foot, Having diabetic patient records in the hospital diabetes clinics, Absence of other chronic diseases, Willingness to participate in the study. exclusion: Having other chronic diseases, No referral to diabetes clinics
Intervention groups
Intervention was made through lectures, practically doing feet examination and special feet exercises, playing films, practicing, group discussion, question and answer, providing educational pamphlets and CDs. Also, individual counseling about foot care with the presence of a doctor and diabetes expert, and psychological counseling with a mental health professional was provided in the clinic; and suitable socks for diabetic foot prevention were distributed among experiment group
Main outcome variables
The results of this study may contribute to designing promotional interventions in these patients.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150531022500N4
Registration date: 2018-09-08, 1397/06/17
Registration timing: retrospective

Last update: 2018-09-08, 1397/06/17
Update count: 0
Registration date
2018-09-08, 1397/06/17
Registrant information
Name
Farbod Ebadi Fard Azar
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8861 0120
Email address
ebadi.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-20, 1396/04/29
Expected recruitment end date
2017-09-22, 1396/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Empowerment of Type 2 Diabetic Patients Visiting Fuladshahr Diabetes Clinics for Prevention of Diabetic Foot
Public title
Empowerment of Type 2 Diabetic Patients on Prevention of Diabetic Foot
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes based on diagnosis of an endocrinologist Absence of diabetic foot Having diabetic patient records in the diabetes clinics Absence of other chronic diseases Willingness to participate in the study
Exclusion criteria:
Having other chronic diseases No referral to diabetes clinics
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 104
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomized
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Department of Health Services and Health Education, School of Health, near Milad Hospital, IUMS, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2017-04-20, 1396/01/31
Ethics committee reference number
IR.IUMS.REC1395.9411107003

Health conditions studied

1

Description of health condition studied
Diabetic Foot
ICD-10 code
Z86.31
ICD-10 code description
Personal history of diabetic foot ulcer

Primary outcomes

1

Description
Perevention of Diabetic Foot
Timepoint
Before the intervention,One month and three months after the implementation of the program
Method of measurement
Checklist

Secondary outcomes

1

Description
Empowerment
Timepoint
Before the intervention,One month and three months after the implementation of the program
Method of measurement
Questionnaire

Intervention groups

1

Description
Intervention group: The experiment group participated in the Foot Care Principles program that was designed based on empowerment strategies. Intervention was made through lectures, practically doing feet examination and special feet exercises, playing films, practicing, group discussion, question and answer, providing educational pamphlets and CDs. Also, individual counseling about foot care with the presence of a doctor and diabetes expert, and psychological counseling with a mental health professional was provided in the clinic; and suitable socks for diabetic foot prevention were distributed among experiment group.Considering the sample’s size and the necessity of grouping the subjects in order to reach more efficacy, the patients were divided into four groups of 13. The duration of each session was about 40-50 minutes. For each of the subgroups, four sessions of empowerment were held on a weekly and regular basis. According to this program, empowerment should be carried out in four steps which are presented in this study in four sessions as follows: the first session included general introduction of diabetes, its mechanism, and complications; the second session was dedicated to the definition of the diabetic foot, its types, etiology, the identification of at-risk foot, risk factors and warning signs; the third session included the description of foot care principles (daily foot examinations, nail care and foot skin care measures, appropriate footwear [shoes and socks] selection criteria, and special foot exercises); and, the forth session included stress management and providing solutions to overcome issues related to foot care.
Category
Prevention

2

Description
Control group: During this period, the control group was receiving the routine services of the clinic
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Diabetes Clinics of Shahid Motahhari Hospital
Full name of responsible person
Dr. Moazemi
Street address
Shahid Motahhari Hospital, َZobahan Highway
City
Fuladshahr
Province
Isfehan
Postal code
8491813113
Phone
+98 31 5262 4141
Email
br3171@bmi.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Kazem Malakooti
Street address
Vice-Chancellor of Technology Research, near Milad Hospital, IUMS, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4817
Email
dr-febadi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
80
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farbod Ebadi fardazar
Position
Professor of managment and Health Services
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Services and Health Education, School of Health, near Milad Hospital, IUMS, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 4817
Email
dr-febadi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farbod Ebadi fardazar
Position
Professor managment and Health Services
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Department of Health Services and Health Education, School of Health, near Milad Hospital, IUMS, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 4817
Email
dr-febadi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farbod Ebadi fardazar
Position
Professor managment and Health Services
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8860 4817
Email
dr-febadi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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