Effect of a Digital Educational Intervention Based on Orem’s Self-Care Theory on Improving Self-Care Behaviors, Self-Efficacy, and Reducing HbA1c in Type 2 Diabetes Patients
To determine the effect of a digital educational intervention based on Orem’s self-care theory on improving self-care behaviors, self-efficacy, and HbA1c levels in patients with type 2 diabetes.
Design
A quasi-experimental, parallel-group, non-randomized, and open-label controlled trial involving 96 patients with type 2 diabetes (48 participants per group).
Settings and conduct
This study was conducted at rural health houses in Rasht County. Multi-stage cluster sampling was used. Questionnaires and blood samples for biochemical analysis were collected at baseline, immediately, and eight weeks post-intervention by the principal researcher.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Type 2 diabetes for over one year; Age over 30 years; Smartphone literacy; Average or below-average self-care score. Exclusion criteria: Unwillingness to continue; Onset of physical or mental disorders; Lack of engagement with the intervention.
Intervention groups
Intervention group: Received eight digital educational sessions including podcasts, videos, and electronic booklets via social media over four weeks; Control group: Received routine healthcare services from the health center without any planned digital educational intervention.
Effect of a Digital Educational Intervention Based on Orem’s Self-Care Theory on Improving Self-Care Behaviors, Self-Efficacy, and Reducing HbA1c in Type 2 Diabetes Patients
Public title
Digital Education and Self-Care in Type 2 Diabetes
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Type 2 diabetes >1 year;
Resident in the study area;
Literacy;
Smartphone use;
Medication adherence;
Age >30;
Absence of complications;
Average or below SCB score.
Exclusion criteria:
Unwillingness to continue;
Lack of engagement with the intervention;
Onset of other diseases;
Physical or mental disorders.
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
48
Actual sample size reached:
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 Tarbiat Modares University
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
111-14115
Approval date
2022-10-25, 1401/08/03
Ethics committee reference number
IR.MODARES.REC.1401.161.
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition
Primary outcomes
1
Description
Glycated hemoglobin A1c level
Timepoint
Baseline (before the intervention) and eight weeks after the completion of the educational intervention
Method of measurement
Blood sampling by laboratory specialists and measuring the percentage of Glycated hemoglobin A1c
Secondary outcomes
1
Description
Total score of diabetes self-care activities
Timepoint
immediately after the intervention, and eight weeks post-intervention
Method of measurement
Summary of Diabetes Self-Care Activities questionnaire
2
Description
Total score of diabetes management self-efficacy
Timepoint
immediately after the intervention, and eight weeks post-intervention
Intervention group: Received eight digital educational sessions over four weeks (two sessions per week, on Saturdays and Wednesdays). Content included audio podcasts, educational videos, and electronic booklets focusing on diet, physical activity, blood glucose monitoring, foot care, and medication adherence. The content was developed based on Orem’s self-care theory and delivered via Eitaa and WhatsApp messengers. Weekly follow-up phone calls were also conducted to encourage participation.
Category
Behavior
2
Description
Control group: This group received routine care from the comprehensive rural health service centers. No digital educational intervention or additional planned content was provided to this group during the study period.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Health houses of rural health centers
Full name of responsible person
Ghorbanali Jennat-Fereidooni
Street address
Marzdasht Health House, Valiasr Street, Khomam Town, Rasht
City
Rasht
Province
Guilan
Postal code
۴۳۴۱۱۵۱۸۸۸
Phone
+98 13 3442 7099
Email
jennatferidooni.g@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Mohammad Javan
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
141173116
Phone
+98 21 8288 4546
Email
mjavan@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Faculty of Medical Sciences, Tarbiat Modares University, Nasr street, Jalal Al Ahmad highway
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
f.zarei@modares.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
Part of the data related to the main outcomes can be shared
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
The data will be made available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
Repeated measures analysis to investigate the effect of training persistence 6 months after the last intervention
From where data/document is obtainable
By sending an email to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir
What processes are involved for a request to access data/document
One week after sending the email from the requester to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir, a reply will be given.