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Effect of virtual education using microlearning versus control group on quality of life and treatment adherence in patients with type 2 diabetes: a randomized clinical trial

Protocol summary

Study aim
To assess the effect of virtual education using microlearning versus control group on quality of life and treatment adherence in patients with type 2 diabetes
Design
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 92 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Settings and conduct
This is a randomized clinical trial with a control group with parallel groups without blinding, in which 92 eligible patients will be randomly assigned to the intervention and control groups using block randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 70 years, Affected with type 2 diabetes for at least 18 months, Score of treatment adherence questionnaire less than 100, Score of quality-of-life questionnaire less than 40, Literate, Access to the internet and domestic social media, Exclusion criteria: Cognitive disorders
Intervention groups
Intervention group: Routine treatment, education and care for diabetic patients plus sending 7 audio podcasts, each audio podcast lasting four minutes, every other day for 14 days, and 14 short text messages daily for 14 days, and 14 text messages with photos, including educational tips, daily for 14 days, and 4 short video messages lasting five minutes, every other day for 14 days through one of the domestic media messages. Control group: Routine treatment, education and care for diabetic patients
Main outcome variables
Primary outcome: Treatment adherence score, Quality of life score

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N575
Registration date: 2025-09-14, 1404/06/23
Registration timing: prospective

Last update: 2025-09-14, 1404/06/23
Update count: 0
Registration date
2025-09-14, 1404/06/23
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-02, 1404/07/10
Expected recruitment end date
2026-02-14, 1404/11/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of virtual education using microlearning versus control group on quality of life and treatment adherence in patients with type 2 diabetes: a randomized clinical trial
Public title
Effect of virtual education using microlearning versus control group on quality of life and treatment adherence in patients with type 2 diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 70 years, Affected with type 2 diabetes for at least 18 months, Score of treatment adherence questionnaire less than 100, Score of quality-of-life questionnaire less than 40, Literate, Access to the internet and domestic social media,
Exclusion criteria:
Cognitive disorders
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: 92
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, random assignment of patients to the intervention and control groups will be carried out using block randomization. To achieve this, four sheets of paper will be prepared - two with the name of the intervention and two with the name of the control. These paper sheets will be pooled and placed in a container. Patients will be selected one at a time without replacement, and for each patient, a paper sheet will be randomly drawn from the container. After each draw, the paper sheets will be returned to the container, and the process will be repeated until the desired sample size is reached.
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 Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2025-08-30, 1404/06/08
Ethics committee reference number
IR.UMSHA.REC.1404.405

Health conditions studied

1

Description of health condition studied
Type 2 diabetes mellitus
ICD-10 code
E08
ICD-10 code description
Diabetes mellitus due to underlying condition

Primary outcomes

1

Description
Treatment adherence score
Timepoint
Before intervention and one and three months after the end of the intervention
Method of measurement
Using the Treatment Adherence Questionnaire

2

Description
Quality of life score
Timepoint
Before intervention and one and three months after the end of the intervention
Method of measurement
Using the Quality-of-Life Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Routine treatment, education and care for diabetic patients plus sending 7 audio podcasts, each audio podcast lasting four minutes, every other day for 14 days (on how to prevent diabetic foot ulcers and how to care for these ulcers), and 14 short text messages daily for 14 days (on diet and appropriate activities), and 14 text messages with photos, including educational tips, daily for 14 days (on how to take medications and their possible side effects), and 4 short video messages lasting five minutes (including short clips with specific concepts related to diabetes), every other day for 14 days through one of the domestic media messages.
Category
Other

2

Description
Control group: Routine treatment, education and care for diabetic patients
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Mahdieh Diabetes Center in Hamadan city
Full name of responsible person
Ehsan Kianijoo
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ehsankianigzem@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Alireza Soltanian
Street address
Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Ehsan Kianijoo
Position
Nursing Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
ehsankianigzem@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Ali Afshari
Position
Specialist in Nursing
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
afshari777@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Fax
Email
poorolajal@umsha.ac.ir

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
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