The effect of integrated educational intervention from Pender's health promotion model and self-regulation theory in insulin injection skill in patients with type 2 diabetes
Determining the effect of integrated educational intervention from Pender's health promotion model and self-regulation theory on insulin injection skill in patients with type 2 diabetes
Design
From the list of patients in endocrinology and metabolism clinic of Firouzgar hospital, patients will be selected and randomly assigned to the control and the intervention group. Will be use block size 4 to randomization.
Settings and conduct
Setting: Endocrinology and Metabolism Clinic, Firouzgar Hospital. Conduct: Seventy eight patients will be selected and randomly assigned to the control and the intervention group. The groups completed the questionnaires and a checklist. Educational sessions will be developed based on the pretest results and will be conducted for the participants in the intervention group. Three months after the intervention, the two groups will be followed and completed the questionnaires and checklist. Finally, the data will be analyzed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: History of diagnosis of type 2 diabetes for at least one year, history of insulin injection for at least 3 months and age 18 to 70 years. Exclusion criteria: History of diagnosed psychological and cognitive problems, history of diagnosed gestational diabetes and discontinuation of insulin (or medication change) by the doctor
Intervention groups
Intervention group: Educational intervention based on the structures of the Pender's health promotion model and self-regulation theory will be designed to address Insulin injection skill and will be done for patients in the intervention group. Control group: No intervention.
Main outcome variables
Primary outcomes: Increasing skill of study participants on Insulin injection. Secondary outcomes: Modifying the attitude and beliefs of participants in terms of Insulin injection.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110727007132N22
Registration date:2023-04-04, 1402/01/15
Registration timing:prospective
Last update:2023-04-04, 1402/01/15
Update count:0
Registration date
2023-04-04, 1402/01/15
Registrant information
Name
Tahereh Dehdari
Name of organization / entity
Iran University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 2188779118263
Email address
t-dehdari@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-05-22, 1402/03/01
Expected recruitment end date
2024-12-21, 1403/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of integrated educational intervention from Pender's health promotion model and self-regulation theory in insulin injection skill in patients with type 2 diabetes
Public title
The effect of integrated educational intervention from Pender's health promotion model and self-regulation theory in insulin injection skill in patients with type 2 diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
History of diagnosed type 2 diabetes for at least one year
History of insulin injection for at least 3 months
Age 18 to 70 years
Living in Tehran province
Having reading and writing literacy in Persian
Exclusion criteria:
History of psychological and cognitive problems
History of diagnosed gestational diabetes
Discontinuation of insulin (or medication change) by the doctor during the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
78
Randomization (investigator's opinion)
Randomized
Randomization description
The list of patients who refer to the endocrinology and metabolism clinic of Firouzgar hospital is available to researchers. We will select 78 patients from this list at random and then randomly assign these individuals to the experimental and control groups. For randomization we will use block size 4. With a sample size of 78, 19 blocks of size 4 will be produced based on this online software: www.sealedenvelope.com.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
There is no special characteristic in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی و خدمات بهداشتی-درمانی ایران
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2023-01-25, 1401/11/05
Ethics committee reference number
IR.IUMS.REC.1401.867
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
Insulin injection skill
Timepoint
Before and three months after the intervention
Method of measurement
Checklist
Secondary outcomes
1
Description
Increasing the perceived benefits of study participants in terms of insulin injection
Timepoint
Before and three months after the intervention
Method of measurement
Questionnaire
2
Description
Reducing the perceived barriers of study participants in terms of insulin injection
Timepoint
Before and three months after the intervention
Method of measurement
Questionnaire
3
Description
Increasing the perceived self-efficacy of study participants in terms of insulin injection
Timepoint
Before and three months after the intervention
Method of measurement
Questionnaire
4
Description
Increasing the activity-related affect of study participants in terms of insulin injection
Timepoint
Before and three months after the intervention
Method of measurement
Questionnaire
5
Description
Increasing the interpersonal influences of study participants in terms of insulin injection
Timepoint
Before and three months after the intervention
Method of measurement
Questionnaire
6
Description
Increasing the situational influences of study participants in terms of insulin injection
Timepoint
Before and three months after the intervention
Method of measurement
Questionnaire
7
Description
Increasing the preferences and decreasing the immediate competing demands of study participants in terms of insulin injection
Timepoint
Before and three months after the intervention
Method of measurement
Questionnaire
8
Description
Increasing the commitment to a plan of action of study participants in terms of insulin injection
Timepoint
Before and three months after the intervention
Method of measurement
Questionnaire
9
Description
Reducing the HbA1c
Timepoint
Before and three months after the intervention
Method of measurement
It is extracted from recorded patients' files
Intervention groups
1
Description
Control group: No intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Clinic of Endocrinology and Metabolism Iran University of Medical Sciences
Full name of responsible person
ramin malboos baf
Street address
Firouzeh Alley, Vali-asr Square
City
Tehran
Province
Tehran
Postal code
1593716615
Phone
+98 21 8603 6064
Fax
Email
malboosbaf.r@gmail.com
Web page address
https://en-iem.iums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Hossein Kaivani
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2504
Email
research@iums.ac.ir
Web page address
https://iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Dr. Tahereh Dehdari
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4756
Email
dehdarit@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Tahereh Dehdari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 4756
Email
dehdarit@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Tahereh Dehdari
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Iran University of Medical Sciences, Shahid Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
009886704756
Email
dehdarit@yahoo.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
The results only will be published in the article.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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