The effect of peer education on adherence to therapeutic regimen in patients with diabetes type 2
Design
At First, six of the type 2 diabetic patients who have the ability to study and Inclusion criteria are selected as peers. They will be given to them before going to diabetes education, and then the researcher will train 2 days a week for 2 hours according to their needs for diabetes. After completing the training, they will be taken from them and 3 will be selected from those who have the highest score . The peers in the presence of the researcher will conduct the exercises necessary for the correct implementation of the training. Then, samples of diabetes patients who come to the diabetes clinic and the criteria for entering the study will be selected. Subsequently, they will be given a " Compliance questionnaire on diabetes treatment" and patients who score poorly to Medium will be included in the study. Then, for each patient, a code is assigned and divided into two groups of 50 patients according to the random numbers table. The control group receives regular diabetic clinic training and the test group receive peer education and diabetes clinics.
Settings and conduct
Conducting classes in Amol Endocrinology Clinic in 2 sessions and 2 weeks per week for 2 hours in 2 groups of 25 patients, 50 of them in the intervention group and 50 in the control group
Participants/Inclusion and exclusion criteria
Inclusion criteria: Have at least 6 months diagnosed with type 2 diabetes by doctor؛ Exclusion criteria: Participating in training program in the last 6 months
Intervention groups
intervention group, patients with type 2 diabetes are being trained by their peers and diabetes clinic for compliance with the diet
control group, type 2 diabetic patients receive routine diabetes clinics for adherence to the treatment regimen.
Main outcome variables
Adherence to the Therapeutic Regimen
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170703034877N2
Registration date:2018-04-24, 1397/02/04
Registration timing:registered_while_recruiting
Last update:2018-04-24, 1397/02/04
Update count:0
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Seyede Marzie Norani
Name of organization / entity
Shahid Beheshti University of Medical Sciences, Faculty of Nursing and Midwifery
Country
Iran (Islamic Republic of)
Phone
+98 21 8865 5367
Email address
norani40@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shahid-Beheshti University of Medical Sciences
Expected recruitment start date
2018-02-08, 1396/11/19
Expected recruitment end date
2018-06-14, 1397/03/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of effect peer education on adherence to therapeutic regimen in patients with type 2 diabetes
Public title
Study of effect peer education on adherence to therapeutic regimen in patients with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes who have been diagnosed by their physician for at least 6 months
The possibility for the patient and the active member of his family to attend classes
Exclusion criteria:
Participating in training program in the last 6 months
Having Physical or psychological problems in person
Inability to read and write
Need to have any surgery
Inability to speak Persian
Age
From 21 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
At first, according to the inclusion criteria , patients were selected; and then each one is given a code and then ; using the random numbers table , the patients will be placed in two groups of intervention and control.
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
Ethics Committee of Shahid- Beheshti University of Medical Sciences
Street address
Shahid Beheshti University of Medical Sciences, adjacent to Ayatollah Taleghani Hospital, Shahid Araji Street., Yemeni Ave., Shahid Chamran Highway, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2016-05-07, 1395/02/18
Ethics committee reference number
IR.SBMU.PHNM. 1394.272
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Adherence to therapeutic regimen
Timepoint
Before, immediately and 3 month after the intervention
Method of measurement
questionnaire
Secondary outcomes
1
Description
Hemoglobin A1c
Timepoint
Before and 3 month after the intervention
Method of measurement
Blood-test
2
Description
Fast blood sugar
Timepoint
Before and 3 months after the intervention
Method of measurement
Blood-test
3
Description
Weight
Timepoint
Before and three months after the intervention
Method of measurement
Scales
Intervention groups
1
Description
Intervention group: Patients with type 2 diabetes receiving diabetes clinics and their counterparts in two 2-hour sessions on adherence to the diet.
Category
Lifestyle
2
Description
Control group: Patients with type 2 diabetes who only receive diabetes clinic training
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital, Amol City, Mazandaran Province
Full name of responsible person
nadereh naderiravesh
Street address
Imam Reza Hospital, Imam Reza Street
City
Amol
Province
Mazandaran
Postal code
4614937597
Phone
+98 11 4327 4012
Email
N.naderiravesh@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. afshin zarghi
Street address
velenjak street . Sheid Beheshti Medical Sience University
City
Tehran
Province
Tehran
Postal code
16316
Phone
+98 21 8846 5512
Email
n.naderiravesh7@gmail.com
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nadereh Naderiravesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, In Front of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2511
Fax
+98 21 8820 2521
Email
N.Naderiravesh7@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nadereh Naderiravesh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Street address
Faculty of Nursing and Midwifery, In Front of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8820 2511
Fax
+98 21 8820 2521
Email
N.Naderiravesh7@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Marzie norani
Position
Master of medical surgical nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, In Front of Shahid Rajaee Heart Hospital, Intersection of Niayesh, Valiasr Street, Tehran
City
Tehran
Province
Tehran
Postal code
4617856954
Phone
+98 21 8865 5367
Fax
Email
marzie.norani66@gmail.com
Web page address
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