This study aimed to determine the effect of peer support on foot care behavior in type 2 diabetic patients.
Design
It is a three-stage, three-group clinical trial involving two intervention groups and one control group.
Settings and conduct
This clinical trial is conducted in one of the diabetes centers in Isfahan. The target group is patients with type 2 diabetes referred to the center. Patients in the intervention group receive 5 sessions of training supported by the peer group and patients in the control group receive more limited training during two training sessions. No blinding was performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having type 2 diabetes for at least one year, Having no active diabetic foot ulcer, Not having medical and paramedical education and no participate in similar research simultaneously, Having no learning disorders
Exclusion criteria: Incomplete participation in the study, Hospitalization to treat diabetes complications during the study
Intervention groups
Intervention group: This group consist of 25 people that divided into two groups. The peers trained their groups for 45 days in 5 one-hour supportive training sessions per week. These trainings were accompanied by weekly workshops, group discussions, question & answer and bug fixes. Peers performed four key functions in peer support, including support in the daily management of foot care in a person with diabetes, providing emotional support, facilitating communication, and assisting in accessing clinical care, and ongoing support.
Main outcome variables
Self-efficacy in foot care behavior, Preventive behaviors in foot care, Harmful behaviors in foot care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037895N4
Registration date:2020-04-04, 1399/01/16
Registration timing:retrospective
Last update:2020-04-04, 1399/01/16
Update count:0
Registration date
2020-04-04, 1399/01/16
Registrant information
Name
Mohsen Torabi Khah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3071
Email address
m.torabikhah@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-10-23, 1398/08/01
Expected recruitment end date
2020-01-21, 1398/11/01
Actual recruitment start date
2019-10-02, 1398/07/10
Actual recruitment end date
2019-12-22, 1398/10/01
Trial completion date
2020-01-12, 1398/10/22
Scientific title
Effect of peer support on foot care in patients with type II diabetes admitted to selected hospital
Public title
Effect of peer support on foot care in patients with type II diabetes
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Reading and writing skills
Fluency in Persian
Having type 2 diabetes for at least one year
Not having speech or hearing disorders
Having no active diabetic foot ulcer
Not having medical and paramedical education and no participate in similar research simultaneously
Having no learning disorders (memory problems, Alzheimer's) or using medications that affect consciousness and learning
Exclusion criteria:
Absent more than two sessions of meetings composed by peers
Patient non-cooperation
Hospitalization to treat diabetes complications during the study
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
50
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Samples were randomly divided into two groups of control and test. This way two cards in same size with number one and two were placed in a pocket. Patients were asked to select one of the cards in the pocket. Those who chose the number one card were included in the test group and those who chose the number two card were placed in the control group. The selection of cards was accompanied by replacement.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The study consisted of two phases of peer selection and education and peer support. In the first phase, four patients with type 2 diabetes including two women and two men who were treated in the study setting with a medical record were selected as peers. These subjects were excluded from the samples but met all the inclusion criteria. After selecting peers, three two-hour training sessions were held for them in the research setting.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences., Street Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.MUI.REC.1396.3.211
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
2
Description of health condition studied
Diabetic foot ulcer
ICD-10 code
E08.621
ICD-10 code description
Diabetes mellitus due to underlying condition with foot ulcer
3
Description of health condition studied
Diabetes type 2
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
4
Description of health condition studied
Diabetic foot ulcer in type 2 diabetes
ICD-10 code
E11.621
ICD-10 code description
Type 2 diabetes mellitus with foot ulcer
Primary outcomes
1
Description
Self-efficacy in foot care
Timepoint
(Before intervention) and immediately and one month after intervention
Method of measurement
Questionnaire
2
Description
Preventive Behaviors in foot Care
Timepoint
(Before intervention) and immediately and one month after intervention
Method of measurement
Questionnaire
3
Description
Harmful behaviors in foot care
Timepoint
(Before intervention) and immediately and one month after intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group consisted of 25 individuals divided into two groups. Each group was assigned a female and a male peer. The peers trained their groups for 45 days in 5 one-hour supportive training sessions per week. Peers performed four key functions in peer support, including support for day-to-day management of foot care in a person with diabetes, emotional support, facilitating communication, and access to clinical care, and ongoing support.
Category
Prevention
2
Description
Control group: The control group also was 25 people. Participants in the control group received routine care, including routine physician visits and participation in diabetic foot care training classes, and participated in two training sessions conducted by the researcher. Finally, in order to observe the research ethics, the educational booklet about the test group sessions was given to the control group patients one month after the intervention and after completing the questionnaire.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kourosh health & diabetes clinic
Full name of responsible person
Sayed Mohammad Hosseini Kazerouni
Street address
Alley 5, Sheikh Mofid St, Sheikh Sadough St
City
Isfahan
Province
Isfehan
Postal code
8164763395
Phone
+98 31 3664 3444
Email
info@kouroshhealth.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghaegh Haghjooe Javanmard
Street address
Isfahan University of Medical Sciences, Street Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673466
Phone
+98 31 3792 7533
Email
sh-haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
60
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
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Ghasemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Street Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Email
ghasemizahra20390@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Zahra Ghasemi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Street Hezarjarib
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Fax
Email
ghasemizahra20390@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Dr.Hojatollah Yousefi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences., Hezarjarib St
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 2918
Email
yousefi@nm.mui.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available