Determination of the effect of peer support on the fear of hypoglycemia
Design
Clinical trials with control group, and intervention, based on community with parallel, randomized groups
Settings and conduct
The place of the province is Vilayat Hospital. To select the peers, the researcher by referring to the clinic and the wards of the provincial hospital and referring to the list of patients who during the year received by their counterparts in the form of training classes for one month (weekly two two-hour sessions) They will get diabetes if they are suffering from diabetes.
Participants/Inclusion and exclusion criteria
Entry requirements: Passing for at least 6 months from a written diagnosis of type 1 diabetes by a specialist, non-use of antidepressants and anxiolytics, non-attendance in diabetes classes in the last 6 months
Exit Conditions: Incorrect participation in training classes, history of participation in similar research, people with type 2 diabetes
Intervention groups
Intervention in this research is by counterparts, ie peer support is the group's training of peers to patients. Then, the patients in the intervention group, in addition to routine interventional protocols in the clinics or departments, receive interventions from their counterparts in the form of training classes for one month, but there is no intervention in the control group.
Main outcome variables
Fear of hypoglycemia
General information
Reason for update
Acronym
-
IRCT registration information
IRCT registration number:IRCT20180623040197N1
Registration date:2018-06-25, 1397/04/04
Registration timing:prospective
Last update:2018-06-25, 1397/04/04
Update count:0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Leila Dehghankar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3333 8034
Email address
l.dehghankar@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-01, 1397/06/10
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of peers support on the fear of hypoglycemia in patients with type I diabetes in Velayat Hospital of Qazvin University Medical Science
Public title
The peers support on the fear of hypoglycemia in patients with type I diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study • Passing for at least 6 months from a written diagnosis of type 1 diabetes by a specialist physician • Reading and writing skills • Lack of physical and psychological disabilities • Non-use of antidepressants and anxiolytics • Non-attendance classes About diabetes in the last 6 months • having enough time to attend group meetings • making direct telephone calls with the patient or active member of the family • the age group 16 to 40 • being able to speak in Farsi
Exclusion criteria:
• History of the company in the same research• Disease that has type 2 diabetes.• Absence more than 2 sessions
Age
From 16 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
To allocate to the control and test groups, the random block method is used 3. By selecting 20 blocks of 3 randomly, from 6 blocks, we will reach the desired volume. The intervention group is randomly divided into 4 groups, and an equal person is assigned to each group randomly and by gender.
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
Qazvin Medical Ethics Committee
Street address
Qazvin, bahonar
City
Qazvin
Province
Qazvin
Postal code
43184-34197
Approval date
2018-05-16, 1397/02/26
Ethics committee reference number
IR.QUMS.REC.1397.032
Health conditions studied
1
Description of health condition studied
Diabet
ICD-10 code
E10
ICD-10 code description
Type 1 diabetes mellitus
Primary outcomes
1
Description
reduction the fear of hypoglycemia
Timepoint
The beginning of the study and one month later intervention
Method of measurement
Hypoglycemia fears questionnaire
Secondary outcomes
1
Description
Glucose control
Timepoint
-
Method of measurement
-
Intervention groups
1
Description
Intervention group: Training through peers to patients in a month for 8 sessions in person, along with a training booklet.
Category
N/A
2
Description
Control group: Control group: Patients do not see any training but routine training in the department
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Velayat
Full name of responsible person
leila dehghankar
Street address
Qazvin-bahonar
City
Qazvin
Province
Qazvin
Postal code
34197-43184
Phone
+98 28 3333 8034
Fax
+98 28 3333 8034
Email
l.dehghankar@qums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
leila dehghankar
Street address
Qazvin
City
Qazvin
Province
Qazvin
Postal code
34197-43184
Phone
+98 28 3333 8034
Fax
+98 28 3333 8034
Email
l.dehghankar@qums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin University of Medical Sciences
Proportion provided by this source
100
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
Qazvin University of Medical Sciences
Full name of responsible person
leila dehghankar
Position
instructor, Faculty member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin-Bahonar
City
Qazvin
Province
Qazvin
Postal code
34197-43184
Phone
+98 28 3333 8034
Fax
+98 28 3333 8034
Email
l.dehghankar@qums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
leili yekefallah
Position
Assistant Professor, Faculty Member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Qazvin. Bahonar
City
Qazvin
Province
Qazvin
Postal code
34197-43184
Phone
+98 28 3333 8034
Fax
+98 28 3333 8034
Email
leili_fallah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
leila dehghankar
Position
instructor,Faculty Member
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Qazvin-Bahonar
City
Qazvin
Province
Qazvin
Postal code
34197-43184
Phone
+98 28 3333 8034
Fax
+98 28 3333 8034
Email
l.dehghankar@qums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Yes - There is 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
Not applicable
Title and more details about the data/document
Information on the main outcome
When the data will become available and for how long
After the article is published, it is possible to access data
To whom data/document is available
All interested
Under which criteria data/document could be used
To conduct research
From where data/document is obtainable
Email Researcher
What processes are involved for a request to access data/document