Protocol summary

Study aim
The aim of the current research is to answer the question whether interventions based on self-efficacy are effective on the life expectancy and quality of life of patients with type 2 diabetes
Design
The number of people investigated in the research will be 70 patients who are selected by easy sampling from the patients who refer to Tarafa hospital clinic and are allocated in two intervention and control groups by random number method using statistical software as pairs and individuals. Each group has 35 people.
Settings and conduct
For the patients of Tarabah hospital clinic, the intervention group will receive 10 sessions of self-efficacy training protocol for one and a half months in two sessions of 20 minutes per week, and the control group will not receive any intervention. After the intervention, the patients of the group The control will also receive the self-efficacy interventions in a compact form and mostly pamphlets.
Participants/Inclusion and exclusion criteria
The criteria for entering the study include having type 2 diabetes, age range 30 to 50 years, at least a diploma education, not having mental problems that require specialized psychological interventions based on personal reports and health records, and the criteria for exiting the study include absence of more than two sessions. and not doing homework and other therapeutic activities.
Intervention groups
For patients in the intervention group, Hijazi et al.'s self-efficacy training protocol will be implemented in 10 sessions for one and a half months, with two 20-minute sessions per week, while the control group did not receive any intervention during this study. They will not, of course, after the completion of the intervention, the patients of the control group will also receive the self-efficacy interventions in an intensive and mostly pamphlet form.
Main outcome variables
Improving the quality and life expectancy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230827059281N1
Registration date: 2023-08-28, 1402/06/06
Registration timing: prospective

Last update: 2023-08-28, 1402/06/06
Update count: 0
Registration date
2023-08-28, 1402/06/06
Registrant information
Name
Amir Ezzati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5574 1753
Email address
a.ezati@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-11, 1402/06/20
Expected recruitment end date
2023-11-11, 1402/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Self-efficacy training on life expectancy and quality of life, in the patients with type 2 diabetes
Public title
The effect of Self-efficacy training on life expectancy and quality of life, in the patients with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Having type 2 diabetes age range of 30-50 years at least a diploma education not having mental problems requiring specialized psychological interventions based on personal reports and health records
Exclusion criteria:
Age
From 30 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
The number of people investigated in the research will be 70 patients who are selected by easy sampling from the patients who refer to Tarafa hospital clinic and are allocated in two intervention and control groups by random number method using statistical software as pairs and individuals. Each group has 35 people.
Blinding (investigator's opinion)
Not blinded
Blinding description
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
No. 23,Ghayomi Alley,Valiasr Streett
City
Tehran
Province
Tehran
Postal code
1594737414
Approval date
2023-08-28, 1402/06/06
Ethics committee reference number
IR.ARAKMU.REC.1402.107

Health conditions studied

1

Description of health condition studied
diabetes
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life based on the quality of life questionnaire score of Bruges et al
Timepoint
Before and after the intervention in the intervention and control group
Method of measurement
Bruges et al. Quality of Life Questionnaire (DQOL)

2

Description
Quality of life based on Omid Schneider questionnaire score
Timepoint
Before and after the intervention in the intervention and control group
Method of measurement
Omid Schneider questionnaire1991

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group:
Category
Other

2

Description
Control group:
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Terfa Hospital
Full name of responsible person
Amir Ezzati
Street address
No 23.Ghayomi Alley , Vaiasr Street
City
Tehran
Province
Tehran
Postal code
1594737414
Phone
+98 21 5574 1753
Email
AmirEzzati0750@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
AmirEzzati
Street address
No 23, Ghayomi Alley ,Valiasr Street
City
Tehran
Province
Tehran
Postal code
1594737414
Phone
+98 21 5574 1753
Email
AmirEzzati0750@gmail.com
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
Amir Ezzati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.23, Ghayomi Alley , Valiasr Street
City
Tehran
Province
Tehran
Postal code
1594737414
Phone
+98 21 5574 1753
Email
AmirEzzati0750@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Amir Ezzati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
NO. 23,Ghayomi Alley , Valieaselr Street ,Tehran
City
Tehran
Province
Tehran
Postal code
1594737414
Phone
+98 21 5574 1753
Fax
Email
AmirEzzati0750@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Amir Ezzati
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No.23, Ghayomi Alley , Valiasr Street
City
Tehran
Province
Tehran
Postal code
1594737414
Phone
+98 21 5574 1753
Email
AmirEzzati0750@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
Loading...