Determining the effect of self-management on self-efficacy and quality of life related to oral and dental health of people with type 2 diabetes
Design
This study will be a double-blind clinical trial on 70 patients with type 2 diabetes. The samples will be assigned to intervention and control groups by block randomization method.
Settings and conduct
This study will be a double-blind clinical trial on 70 patients with type 2 diabetes. The place of implementation of the study will be the Diabetes Clinic of Taraba Hospital. The samples will be assigned to intervention and control groups by block randomization method.
The control group will receive the common trainings of the diabetes clinic, but in the intervention group, 12 sessions of self-management training based on the 5-step model A will be conducted for 12 weeks and each session will last 30 to 45 minutes.
Participants/Inclusion and exclusion criteria
Entry requirements:
1. Patients with type 2 diabetes (at least 3 to 6 months have passed since the definitive diagnosis of type 2 diabetes)
2. Age range from 20 to 70 years
3. Proficiency in Persian language
4. Having hearing and sight
5. Not suffering from mental illnesses or using psychoactive drugs
6. Willingness to participate in the study
Non-entry conditions:
1. Unwillingness to participate in the study
2. Participation in self-management courses
Intervention groups
The control group will receive the common trainings of the diabetes clinic, but in the intervention group, 12 sessions of self-management training based on the 5-step model A will be conducted for 12 weeks and each session will last 30 to 45 minutes.
Main outcome variables
Self-Efficacy And Quality Of Life Related To Oral Health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20220709055421N2
Registration date:2023-01-05, 1401/10/15
Registration timing:prospective
Last update:2023-01-05, 1401/10/15
Update count:0
Registration date
2023-01-05, 1401/10/15
Registrant information
Name
Mahtab Farahani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3505
Email address
m.farahani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-24, 1401/11/04
Expected recruitment end date
2023-04-24, 1402/02/04
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect Of Self-Management On Self-Efficacy And Quality Of Life Related To Oral Health In Patients With Type 2 Diabetes
Public title
The effect of self-management on the oral and dental health of patients with diabetes
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with type 2 diabetes (at least 3 to 6 months have passed since the definitive diagnosis of type 2 diabetes)
Age range from 20 to 70 years
Proficiency in Persian language
Having hearing and sight
Not suffering from mental illnesses or using psychoactive drugs
Willingness to participate in the study
Exclusion criteria:
Unwillingness to participate in the study
Participation in self-management courses
Age
From 20 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be done by available method, and if the research samples are eligible to participate in the study, they will be placed in one of the test or control groups by random blocks of four (A, A, B, B). Code A will be assigned to the intervention group and code B will be assigned to the control group
Blinding (investigator's opinion)
Double blinded
Blinding description
Since the researcher will perform the intervention and another colleague will collect the data, and also considering that the person who will also perform the data analysis will not know about the codes assigned to the patient, this study is It will be double-blind.
Placebo
Not used
Assignment
Factorial
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
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Approval date
2022-11-20, 1401/08/29
Ethics committee reference number
IR.ARAKMU.REC.1401.241
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
Self-Efficacy Related To Oral Health
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Oral and dental health self-efficacy questionnaire OHSQ
Secondary outcomes
1
Description
Quality Of Life Related To Oral Health
Timepoint
Before the start of the intervention and after the end of the intervention
Method of measurement
Quality of life questionnaire related to oral health (OHIP-14)
Intervention groups
1
Description
Intervention group: In the intervention group, 12 sessions of self-management training based on the 5-step model A will be conducted for 12 weeks, each session lasting 30 to 45 minutes.
Category
Lifestyle
2
Description
Control group: The control group will receive the common trainings of the diabetes clinic.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
بیمارستان طرفه
Full name of responsible person
محمدعلی مردم
Street address
in front of Islamic Propaganda Organization., Ibn Sina St., Baharestan Square., Torfe hospital
City
Tehran
Province
Tehran
Postal code
1333685741
Phone
+98 21 7762 6550
Email
Torfehospital@sbmu.ac.ir
Web page address
https://tomc.sbmu.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Arak University of Medical Sciences
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
info@arakmu.ac.ir
Web page address
https://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
MohammadAli Mardom
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
m.ali.mardom@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Mahbobeh Sajadi
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
sajadimahbobeh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
MohammadAli Mardom
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Alam El Hadi St., Shahid Shiroudi St
City
Arak
Province
Markazi
Postal code
3819693345
Phone
+98 86 3313 6055
Email
m.ali.mardom@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
Information and results will be published in the form of articles.