Determination of the Effect of Health Belief Model-Based Education on Health Literacy and Self-Care of Patients with Type 2 Diabetes
Design
The clinical trial has a control group, with parallel groups, without blinding, randomized on 120 patients with type 2 diabetes, using a table of random numbers.
Settings and conduct
The study population consists of type 2 diabetes patients covered by the Arak health center in 2023. Among the health centers in Arak, eight centers are selected, with four centers randomly chosen as the intervention group and four centers selected as the control group. The selection of patients in the centers is based on a random sampling of diabetes patients registered in the Sib system.
Participants/Inclusion and exclusion criteria
The inclusion criteria for this research are as follows:1. Aged 30- to 60 years 2- Diagnosis of diabetes for more than 1 year 3- Ability to read and write 4- No severe complications of the disease 5- Willingness to participate in the study.
Exclusion criteria include:1-. Reluctance to participate in the study 2- Absence from more than one training session 3- Change of residence 4- Suffering from complications of the disease and receiving special treatments
Intervention groups
The questionnaires in this study are completed before the training intervention for both the intervention and control groups. After the initial analysis of the questionnaires, training content is prepared, and a training session is held for the intervention group. Three months after the training intervention, the questionnaires will be completed again for both the intervention and control groups.
Main outcome variables
1- Health literacy
2- Self-care behaviors
3- Perceived sensitivity, perceived severity, perceived barriers, perceived benefits and self-efficacy
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240216061026N1
Registration date:2024-08-14, 1403/05/24
Registration timing:prospective
Last update:2024-08-14, 1403/05/24
Update count:0
Registration date
2024-08-14, 1403/05/24
Registrant information
Name
Nastaran sedaghat niya
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3226 5244
Email address
nastaransedaghatnia@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-09-05, 1403/06/15
Expected recruitment end date
2024-09-20, 1403/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of education based on the health belief model on health literacy and self-care of patients with type 2 diabetes
Public title
Investigating the effect of education based on the health belief model on health literacy and self-care of patients with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age 30 to 60 years
The duration of diabetes is more than 1 year after the doctor's diagnosis
Being literate in reading and writing
Having severe disease complications (nephropathy, retinopathy and neuropathy)
Willingness to participate in the study
Exclusion criteria:
Reluctance to do the test
Absence of more than one training session
Change of residence
Having complications of the disease and undergoing special treatments
Age
From 30 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, sampling is done in a stratified manner. First, the city of Arak is divided into 4 regions from the economic-social point of view, and 2 health centers are selected from each region, and a total of 8 centers are selected for sampling. Then 2 centers are selected from each region and one center is randomly assigned as an intervention center and the other as a control center. That is, in general, out of the 8 centers selected for the study, 4 centers are randomly assigned to the intervention and 4 centers to the control.
Then, based on the number of samples determined for each center, from the patients registered in the Sib system, people are selected randomly (through a table of random numbers) taking into account the entry and exit criteria.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Arak University of Medical Sciences
Street address
University complex of the Prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Approval date
2024-05-26, 1403/03/06
Ethics committee reference number
IR.ARAKMU.REC.1403.080
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
Health literacy score
Timepoint
At the beginning of the study and 3 months after the end of the intervention
Method of measurement
Standard health literacy questionnaire
2
Description
Self-care score
Timepoint
At the beginning of the study and 3 months after the end of the intervention
Method of measurement
Standard self-care questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group: The teach back method is a technique in which the trainer teaches the patient the material in simple language without using medical terms and asks the patient to repeat the material as he understood it. If the patient understands the material well If not, the trainer repeats the training content for the client until he fully understands.
Category
Other
2
Description
Control group: In the control group, there is no intervention and people benefit from their routine care and training.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arak health center
Full name of responsible person
Shahriar Hosseini
Street address
Shahidbeheshti settlement phase 2 next to the municipality, Hepko Street
City
Arak
Province
Markazi
Postal code
3177838189
Phone
+98 86 3313 9037
Fax
+98 86 3313 1117
Email
arakmarkazi@arakmu.ac.ir
Web page address
https://arakmu.ac.ir/arakdh/fa
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Dawood Hekmat Po
Street address
University complex of the Prophet, Basij square, Sardasht
City
Arak
Province
Markazi
Postal code
3848176941
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Web page address
https://www.arakmu.ac.ir/fa
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Arak University of Medical Sciences
Full name of responsible person
Nastaran Sedaghat niya
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Horeban Al-Riyahi Street, Tohid town
City
Arak
Province
Markazi
Postal code
3817785388
Phone
+98 86 3226 5244
Email
nastaransedaghatnia@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nastaran Sedaghat niya
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Horeban Al-Riyahi Street, Tohid town
City
Arak
Province
Markazi
Postal code
3817785388
Phone
+98 86 3226 5244
Email
nastaransedaghatnia@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Nastaran Sedaghat niya
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Health Promotion
Street address
Horeban Al-Riyahi Street, Tohid town
City
Arak
Province
Markazi
Postal code
3817785388
Phone
+98 86 3226 5244
Email
nastaransedaghatnia@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
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