The effect of teaching self-management behaviors in patients with type 2 diabetes, using BRT theory, will be for the first time in Bushehr
Design
A simple non- randomized clinical trial on 120 patients with type 2 diabetes in the control and intervention groups
Settings and conduct
120 patients with type 2 diabetes will be randomly selected from 4 health centers and bases in Bushehr, if they meet the inclusion criteria, and after obtaining informed consent in writing, randomly, patients will be divided into two groups. Control and intervention will be divided. The educational content will be provided to the intervention group in person and virtually, and at the end of the work, the educational content will be available to the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria for this study are:
Type 2 diabetes based on a definite diagnosis by a doctor• At least one year has passed since the definitive diagnosis of the disease • Ability to read, write and speak Persian •Having a smartphone and the ability to use WhatsApp • Age between 30 and 60 years• No severe complications from diabetes, including eye disease, kidney disease and foot / skin ulcers
• Willingness to participate in the study
Exclusion criteria are:
• Severe complications of diabetes during the study period• Withdrawal from continuing to participate in the study •Death .Migration
Intervention groups
The intervention group consists of 2 patients with type 2 diabetes (the target group first selected from four comprehensive health centers in Bushehr, then divided into two groups of control and intervention, followed by fasting blood sugar, HBA1C and height and size of patients size. It will be obtained and will be completed by the target group at a group meeting of demographic questionnaires and questionnaires based
Main outcome variables
Improving the quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20131014015015N21
Registration date:2022-08-14, 1401/05/23
Registration timing:registered_while_recruiting
Last update:2022-08-14, 1401/05/23
Update count:0
Registration date
2022-08-14, 1401/05/23
Registrant information
Name
Leila Ghahremani
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1725 1001
Email address
ghahramanl@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-22, 1401/02/02
Expected recruitment end date
2022-11-21, 1401/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of educational intervention based on behavioral reasoning theory on self-management behaviors in patients with type 2 diabetes
Public title
The effect of teaching self-management behaviors in patients with type 2 diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least one year has passed since the definitive diagnosis of the disease
Ability to use WhatsApp
No severe complications from diabetes, including eye disease, kidney disease and foot / skin ulcers
Willingness to participate in the study
Exclusion criteria:
• Severe complications of diabetes
Lack of interest in training and attending meetings
History of mental illness
Death
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Schools of Health, Nutrition and Food Sciences - Shiraz University of Medical Sc
Street address
No. 6, Mehr Alley 18, Sabzabad Street, Bushehr City, Bushehr Province, Iran
City
Bushehr
Province
Boushehr
Postal code
7516979833
Approval date
2022-02-26, 1400/12/07
Ethics committee reference number
IR.SUMSSCHEANUT.REC.1400.101
Health conditions studied
1
Description of health condition studied
type 2 diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Educating and promoting self-management behaviors in patients with type 2 diabetes by the educator
Timepoint
Three and six months after the educational intervention
Method of measurement
Questionnaire and behavior assessment checklist
Secondary outcomes
empty
Intervention groups
1
Description
"The intervention group" will include 60 patients with type 2 diabetes over 30 years old, residing in Bushehr, which will be offered in a combination of eight in -person and virtual training sessions for two months. Virtual training content contains short videos, text and audio messages and photos, including fasting blood glucose checks, HBA1C and patients' height and weight, and a notebook will be given to people daily.
Category
Behavior
2
Description
"The control group "will include 60 patients with type 2 diabetes over the age of30, residing in Bushehr, which will receive only regular education and care in the health system during this period. Three and six months after the end of the educational interventions, questionnaires based on the structures of behavioral reasoning model will be completed by the two groups
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Bushehr health centers and health centers
Full name of responsible person
Fatemeh Ranjbar
Street address
No. 2 Mehr Alley, Sabzabad Street, Bushehr, Bushehr Province, Iran
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۶۹۷۹۸۳۳
Phone
+98 917 552 5591
Email
fatima.fr612@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Ranjbar
Street address
No. 2 Mehr Alley, Sabzabad Street, Bushehr, Bushehr Province, Iran
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۶۹۷۹۸۳۳
Phone
+98 917 552 5591
Email
fatima.fr612@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
30
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
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Ranjbar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 2 Mehr Alley, Sabzabad Street
City
Bushehr
Province
Boushehr
Postal code
۷۵۱۶۹۷۹۸۳۳
Phone
+98 917 552 5591
Email
fatima.fr612@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Leila Ghahramani
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Zahra Alley, 16th Alley, Behzisti, Shiraz University of Medical Sciences, School of Health, Building No. 1, 3rd Floor, Department of Health Promotion
City
Shiraz
Province
Fars
Postal code
71345-1978
Phone
+98 917 552 5591
Email
fatima.fr612@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh ranjbar
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
No. 2 Mehr Alley, Sabzabad Street, Bushehr, Bushehr Province, Iran
City
Buhsher
Province
Boushehr
Postal code
۷۵۱۶۹۷۹۸۳۳
Phone
+98 917 552 5591
Email
fatima.fr612@gmail.com
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