Investigating the effect of self-care training on the disease management of people with diabetes in prevention and health promotion clinics affiliated to Hamedan University of Medical Sciences in 2024
The effect of self-care training on disease management of people with diabetes
Design
A clinical trial with a control group, with parallel groups, not blinded, non-randomized
Settings and conduct
The place of the project is in prevention and health promotion clinics. The method of data collection is that in the initial phase and before diabetes self-care training, both intervention and control groups will complete questionnaires, then in the second phase of the study and three months after receiving self-care training in the intervention group, questionnaires will be distributed again and will be completed.
Participants/Inclusion and exclusion criteria
Confirmation of diabetes by a doctor (type one or type two); At least 6 months have passed since the diagnosis of diabetes; Being literate in reading and writing in the patient; Age over ten years
Intervention groups
The intervention group will undergo diabetes self-care training by social medical specialists, and the control group will only be monitored for three months.
Main outcome variables
Quality of Life; foot care status; adherence to the Mediterranean diet; physical activity; Medication compliance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141027019694N2
Registration date:2024-01-03, 1402/10/13
Registration timing:prospective
Last update:2024-01-03, 1402/10/13
Update count:0
Registration date
2024-01-03, 1402/10/13
Registrant information
Name
Azar Pirdehghan
Name of organization / entity
Hamadan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0572
Email address
a.pirdehghan@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-31, 1402/11/11
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of self-care training on the disease management of people with diabetes in prevention and health promotion clinics affiliated to Hamedan University of Medical Sciences in 2024
Public title
The effect of diabetes self-care education on diabetes management
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Confirmation of diabetes by a doctor (type 1 or type 2 diabetes)
At least 6 months have passed since the diagnosis of diabetes
Being literate in reading and writing in the patient
Age over ten years
Willingness to participate in the study
Exclusion criteria:
Having a cognitive problem
Suffering from serious and debilitating complications caused by diabetes, such as severe kidney failure, heart failure, blindness, etc
Having concurrent diseases (comorbidity)
Use of immunosuppressive drugs and corticosteroids
Age
From 10 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
96
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 Hamedan University of Medical Sciences
Street address
address: Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St. zip code: 6517838736
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Approval date
2023-11-05, 1402/08/14
Ethics committee reference number
IR.UMSHA.REC.1402.564
Health conditions studied
1
Description of health condition studied
Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
The self-care score in the diabetes self-care questionnaire
Timepoint
At the beginning of the study (before the start of the intervention) and 3 months after the self-care training
Method of measurement
Diabetic self-care questionnaire
Secondary outcomes
1
Description
Quality of life score
Timepoint
At the beginning of the study and three months after the self-care training
Method of measurement
Quality of life questionnaire
2
Description
Foot care status
Timepoint
At the beginning of the study and three months after the self-care training
Method of measurement
Foot care status questionnaire
3
Description
Adherence to the Mediterranean diet
Timepoint
At the beginning of the study and three months after the self-care training
Method of measurement
Mediterranean diet compliance questionnaire
4
Description
Physical activity status
Timepoint
At the beginning of the study and three months after the self-care training
Method of measurement
Physical activity questionnaire
5
Description
Medication adherence
Timepoint
At the beginning of the study and three months after the self-care training
Method of measurement
Medication compliance questionnaire
Intervention groups
1
Description
Intervention group: In the prevention and health promotion clinics, the specialists of the social medicine group provide face-to-face training for diabetic patients who refer to the centers after taking a comprehensive history, complete examinations and completing a comprehensive health file. The self-care education of patients in this study is direct and indirect. In direct education, social medical specialists teach patients the basic principles and how to self-care for diabetes in person and for one hour. Educational axes in the DSME approach with the aim of improving blood sugar control include reducing glycosylated hemoglobin and fasting blood sugar, as well as increasing patients' compliance in the correct use of medications and lifestyle modification in order to reduce complications and increase quality of life, and include the definition of the disease, a summary of the disease process, Complications of diabetes, ways to prevent complications, nutrition in diabetes, the need to exercise, how to perform physical activities, how and when to measure blood sugar by a diabetic person, medications and how to take them correctly and regularly, how to inject insulin and medication side effects, self-management of change Behavior and control of stress and quitting unhealthy behaviors from before such as smoking and alcohol consumption and the time and intervals of referrals to check eye, heart and kidney complications. Risk assessment is done for patients and preventive measures are recommended at different levels based on age and sex and risk level. Necessary screenings are also performed. In indirect education, manuals and pamphlets and approved online sites are introduced to patients with various subjects of self-care education to study at home (study duration is about 2.5-3 hours). The duration of teaching patients is about four hours in total.
Category
Behavior
2
Description
Control group: This group is only monitored for three months without receiving self-care training by social medical specialists.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Be'sat Hospital
Full name of responsible person
Azar Pirdehghan
Street address
Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St. - zip code: 6517838736
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Reza Shokohi
Street address
Hamadan University of Medical Sciences Headquarters, Shahid Fahmideh St.
City
Hamedan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3131 0000
Email
webda@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Erfan Rajabi
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Number 35, Ghadir dead end, Sheghaiq Alley, Sanati St, Resalat Square
City
Hamedan
Province
Hamadan
Postal code
6515798737
Phone
+98 81 3822 1862
Email
erfanrajabi542@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azar Pirdehghan
Position
Community medicine assistant proffessor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Community medicine department, Medical school, Hamadan University of medical sciences, Hamadan, Iran.
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 0572
Fax
Email
a.pirdehghan@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Azar Pirdehghan
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Public Health/Community Medicine
Street address
Community medicine department, Medical school, Hamadan University of medical sciences, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
۶۵۱۷۸۳۸۷۳۶
Phone
+98 81 3838 0572
Fax
+98 81 3838 0208
Email
a.pirdehghan@umsha.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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
In order to compare with similar studies and perform meta-analysis