Investigating the effect of team-oriented educational intervention on promoting self-care in women with type 2 diabetes; A cluster randomized controlled trial using social-cognitive theory
Determining the effect of team-oriented educational intervention on promoting self-care in women with type 2 diabetes; A cluster randomized controlled trial using cognitive-social theory in Boushehr city, south of Iran.
Design
The study has two intervention and control groups, which were selected by regular random method, the target sample size is 110 people, and there is no blinding
Settings and conduct
This research was conducted among women aged 30 to 59 years old with diabetes, whose disease was registered in the integrated health system of selected comprehensive health service centers, by conducting a team-oriented educational intervention and by forming a team including a health care provider, doctor, patient, peers and the patient's family. Blood tests and questionnaires will be completed before and after the training
Participants/Inclusion and exclusion criteria
Entry requirements:
Type 2 diabetes based on the definitive diagnosis entered in the file
At least one year has passed since the definitive diagnosis of the disease
Ability to read, write and speak Farsi
Age between 30 and 59 years
Not having severe complications caused by diabetes, including eye disease, kidney disease, and leg/skin ulcers
Willingness to participate in the study
Exit conditions:
The occurrence of a severe health condition that prevents the person from continuing to attend and participate in the course
Leaving the research environment for any reason (withdrawal, death and migration)
Absence of more than 2 sessions of the training program
Failure to participate in the pre-test and post-test•
Participation in the ongoing program similar to the present study
Intervention groups
Team-oriented educational intervention using social cognitive model in women with type 2 diabetes
Main outcome variables
Knowledge;behavioral intention;outcome expectation; perceived social support;self-efficacy;HbA1c; FBS;self-care
General information
Reason for update
Acronym
SCT
IRCT registration information
IRCT registration number:IRCT20230521058243N1
Registration date:2023-05-31, 1402/03/10
Registration timing:registered_while_recruiting
Last update:2023-05-31, 1402/03/10
Update count:0
Registration date
2023-05-31, 1402/03/10
Registrant information
Name
Azadeh Salemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77 3333 0741
Email address
azadehsalemi87@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-23, 1402/03/02
Expected recruitment end date
2023-07-22, 1402/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of team-oriented educational intervention on promoting self-care in women with type 2 diabetes; A cluster randomized controlled trial using social-cognitive theory
Public title
Investigating the effect of education on self-care in women with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes based on the definitive diagnosis entered in the file
At least one year has passed since the definitive diagnosis of the disease
Ability to read, write and speak Farsi
Age between 30 and 59 years
Not having severe complications caused by diabetes, including eye disease, kidney disease, and leg/skin ulcers
Willingness to participate in the study
Exclusion criteria:
The occurrence of a severe health condition that prevents the person from continuing to attend and participate in the course
Leaving the research environment for any reason (withdrawal, death and migration)
Absence of more than 2 sessions of the training program
Failure to participate in the pre-test and post-test•
Participation in the ongoing program similar to the present study
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
110
Randomization (investigator's opinion)
Randomized
Randomization description
To select the samples using a multi-stage cluster method, first, among the 12 comprehensive health service centers in Boushehr, all of which provide services in the diabetes prevention and control program to people with diabetes, 4 comprehensive health service centers were selected. A simple random method will be selected, then in this step, in order to prevent information leakage of these 4 centers, 2 centers were selected by a simple random method (lottery method) and assigned to the intervention groups and 2 centers to the control groups. They will be .In the next step, a list of people with diabetes who meet the criteria for entering the study will be prepared by using the information registered in the Integrated Health System (SIB). Then, with regular random method, the desired sample size will be selected from among them. After obtaining informed consent from the people, and having the entry criteria, then they complete the prepared questionnaires.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz, Zand Street, Shiraz University of Medical Sciences Central Building, 7th Floor, Research and Technology Deputy
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2023-05-20, 1402/02/30
Ethics committee reference number
IR.SUMS.SCHEANUT.REC.1402.024
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Changes in the mean scores of knowledge related to diabetes
Timepoint
before the intervention and 3 months after the intervention
Method of measurement
Questionnaire
2
Description
Changes in the mean scores of diabetes self-care behavior intention
Timepoint
before the intervention and 3 months after the intervention
Method of measurement
Questionnaire
3
Description
Changes in the mean scores of participants' outcome expectations
Timepoint
before the intervention and 3 months after the intervention
Method of measurement
Questionnaire
4
Description
Changes in the mean scores of participants' perceived social support
Timepoint
before the intervention and 3 months after the intervention
Method of measurement
Questionnaire
5
Description
Changes in the mean scores of participants' perceived self-efficacy
Timepoint
before the intervention and 3 months after the intervention
Method of measurement
Questionnaire
6
Description
Changes in the average amount of glycosylated hemoglobin
Timepoint
before the intervention and 3 months after the intervention
Method of measurement
blood test
7
Description
Changes in the average amount of fasting blood sugar
Timepoint
before the intervention and 3 months after the intervention
Method of measurement
blood test
8
Description
Changes in the mean scores of participants' self-care behavior
Timepoint
before the intervention and 3 months after the intervention
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Education about diabetes and the importance of self-care and its elements, familiarity with controlling and monitoring blood sugar and blood pressure, prevention of diabetes complications, healthy eating and physical activity, correct use of medicine, foot care and interaction with peer group, family, health care provider and doctor , in person to the intervention group, in 6 sessions of 60 to 80 minutes with the method of interactive lectures, group discussions and also using media such as: slide show in PowerPoint format, clip show, practical show and booklet in line with knowledge structures. Behavioral intention, outcome expectancy, perceived self-efficacy and perceived social support will be conducted
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Comprehensive urban health service centers of Bushehr province
Full name of responsible person
Mohammad Hosein Kaveh
Street address
Shiraz, Razi Blvd
City
Shiraz
Province
Fars
Postal code
۷۵۵۴۱ - ۷۱۵۳۶
Phone
+98 71 3725 1001
Email
Mhkaveh255@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hshempour
Street address
Shiraz, Zand Street, Shiraz University of Medical Sciences Central Building, 7th Floor, Research and Technology Deputy
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
vcrdep@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Boushehr University of Medical Sciences
Full name of responsible person
Azadeh Salemi
Position
Employee
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Bushehr, Moalem St., in front of Friday prayer, Bushehr University of Medical Sciences and Health Services
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
00987133322081-5
Email
azadehsalemi87@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hosein Kaveh
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Shiraz, Razi Blvd
City
Shiraz
Province
Fars
Postal code
۷۵۵۴۱ - ۷۱۵۳۶
Phone
+98 71 3725 1001
Email
Mhkaveh255@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Boushehr University of Medical Sciences
Full name of responsible person
Azadeh Salemi
Position
Employee
Latest degree
Bachelor
Other areas of specialty/work
Public Health
Street address
Bushehr, Moalem St., in front of Friday prayer, Bushehr University of Medical Sciences and Health Services
City
Boushehr
Province
Boushehr
Postal code
7514633341
Phone
+98 77 3332 2081
Email
azadehsalemi87@gmail.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
Due to confidentiality of information
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
No - There is not 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