A study on The Effect of performing self-efficacy increasing program on type 2 diabetic patients HbA1c control referred to Urmia society of diabetes, 2016
evaluate the effect of self-efficacy training program on HbA1c in patients with type 2 diabetes.
Design
Quasi-experimental intervention with control group, with parallel groups, available sampling and random allocation
Settings and conduct
Location: Urmia Society of Diabetes
Background: Educational intervention based on the concept of self-efficacy of social cognitive theory
After sampling the class was conducted and variables were investigated.
Participants/Inclusion and exclusion criteria
Inclusion criteria: People who are willing to participate in the study, have Type 2 diabetes diagnosis and have had a diagnosis of diabetes for at least one year, have literacy and writing skills, and have high school education, over the age of 30, and They do not use insulin.
Exit criteria: Those who do not want to participate in the study, those with severe physical, cognitive and visual impairment that interfere with the ability to participate in the study and patients with gestational diabetes or other types of diabetes will be excluded from the study. Those who have to use insulin during the study will be excluded. If the patient has two or more absence during the sessions, will be exclude
Intervention groups
132 patients with type 2 diabetes will be selected through available sampling and randomly divided into two groups of intervention (Received self-efficacy educational program) and control (Received usual education). Participants in the self-efficacy-based intervention group and control group will receive regular training. The data collection tool will be self-efficacy questionnaire for patients with type 2 diabetes and HbA1c measurements. Data using descriptive and inferential statistics will be analyzed.
Main outcome variables
self-efficacy, HbA1c
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180910040987N1
Registration date:2018-10-29, 1397/08/07
Registration timing:registered_while_recruiting
Last update:2018-10-29, 1397/08/07
Update count:0
Registration date
2018-10-29, 1397/08/07
Registrant information
Name
rasoul zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3383 4745
Email address
rznurse@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-22, 1397/06/31
Expected recruitment end date
2019-02-19, 1397/11/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study on The Effect of performing self-efficacy increasing program on type 2 diabetic patients HbA1c control referred to Urmia society of diabetes, 2016
Public title
A study on The Effect of performing self-efficacy increasing program on type 2 diabetic patients HbA1c control
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People who are willing to participate in the study
Have a diagnosis of type 2 diabetes
One year has passed since their diagnosis of diabetes
They have literacy and reading skills, and have high-level education
They are over 30 years old
Does not use insulin
Exclusion criteria:
Those with severe physical, cognitive and visual impairment that interfere with the ability to participate in the study (e.g., end-stage renal disease, hemodialysis, acute myocardial infarction, acute cerebrovascular accidents, or events that cause cognitive impairment)
People with gestational diabetes and type 1 diabetes will not be included in the study.
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
132
Actual sample size reached:
132
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: Simple
Random unit: Individual
Randomization Tool: Cards
How to create a random sequence: 66 cards with the letter A (for the intervention group) and 66 cards with the letter B (control group) written in such a way that the participant and researcher are not aware of their words randomly Will be selected.
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 Urmia University of Medical Sciences
Street address
Resalat Blvd. urmia town.
City
urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2016-06-16, 1395/03/27
Ethics committee reference number
IR.UMSU.REC.1395.328
Health conditions studied
1
Description of health condition studied
diabetes
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
self-efficacy
Timepoint
Before the intervention, after the end of the meeting (one month) and three months after the end of the meeting
Method of measurement
Self-efficacy questionnaire for patients with type 2 diabetes
Secondary outcomes
1
Description
HbA1c
Timepoint
Before the intervention and four months later
Method of measurement
spectrography
Intervention groups
1
Description
Intervention group: The intervention group will receive educational content based on self-efficacy. There will be four sessions in person (one session per week). The duration of the sessions is between 30 and 60 minutes. Patients in the intervention group will be divided into groups of 10. Before contacting patients, they will be contacted by telephone and will be encouraged to attend the meeting. After the end of the meeting, the patient has a phone call for up to 3 months
Category
Behavior
2
Description
Control group: The control group will receive the usual education
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
انجمن دیابت ارومیه
Full name of responsible person
Ahmad anari
Street address
Municipality Health Building, Mehrab, ave, Resalat Blvd, urmia
City
urmia
Province
West Azarbaijan
Postal code
5719957395
Phone
+98 44 3336 6487
Email
khairieh.ir@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Iraj Mohebbi
Street address
Urmia University of medical sciences, Resalat Blvd, urmia
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3193 7224
Email
mohebbi_iraj@yahoo.co.uk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia 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
Oroumia University of Medical Sciences
Full name of responsible person
Rasoul Zare
Position
Student of master of sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 18, Valizadeh ave, Farrokhi Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3383 4745
Fax
Email
rznurse@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rasoul Zare
Position
Student of master of sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 18, Valizadeh ave, Farrokhi Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3383 4745
Fax
Email
rznurse@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Rasoul Zare
Position
Student of master of sciences
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No. 18, Valizadeh ave, Farrokhi Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3383 4745
Fax
Email
rznurse@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