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Effect of Leventhal's Model-Based Education on Treatment Adherence, Intraocular Pressure, and Visual-Related Quality of Life, in Glaucoma Patients

Protocol summary

Study aim
Effect of Leventhal model training on intraocular pressure, treatment adherence, and vision-related quality of life in glaucoma patients.
Design
A single-blind, randomized, parallel-group clinical trial will enroll 90 patients with glaucoma. Participants will be selected using a convenient method and then assigned to either an intervention or control group, with the assignment determined by color-coded cards.
Settings and conduct
Patients with glaucoma referred to Al-Zahra Ophthalmology Hospital (S) in Zahedan will be randomized 1:1 into intervention and control groups. The intervention group will receive four individual training sessions based on the Leventhal model, covering the nature, causes, symptoms, consequences, progression, and management of the disease. Social and cultural factors that influence understanding will be identified and adjusted as necessary. The control group will receive standard clinic training. A trained, blinded nurse will measure treatment adherence, vision-related quality of life, and intraocular pressure in both groups at baseline and after 8 weeks.
Participants/Inclusion and exclusion criteria
Suffering from glaucoma 18 years old Basic literacy Having a Phone for coordination Willingness to participate in the study Using medication to lower eye pressure Severe secondary visual impairment (Cataracts, Macular degeneration). Mental retardation Hearing impairment
Intervention groups
The intervention group will receive four individual training sessions based on the Leventhal model, covering disease identity, etiology, consequences, course, and management. Social and cultural factors influencing patients' understanding will also be addressed and modified as needed. The control group will receive standard clinic training.
Main outcome variables
Intraocular Pressure

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250901067070N1
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
Bibi Mahdieh Khodadadi Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 930 202 5131
Email address
mahdieh_kh@zbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-10-23, 1404/08/01
Expected recruitment end date
2026-10-23, 1405/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Leventhal's Model-Based Education on Treatment Adherence, Intraocular Pressure, and Visual-Related Quality of Life, in Glaucoma Patients
Public title
Effect of Leventhal's Model-Based Education on Glaucoma Patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from glaucoma 18 years old Basic literacy Having a Phone for coordination Willingness to participate in the study Using medication to lower eye pressure
Exclusion criteria:
Severe secondary visual impairment (Cataracts, Macular degeneration). Mental retardation Hearing impairment
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are randomly assigned to either the intervention or control group (1:1 ratio) by drawing colored cards from a concealed box. The box contains an equal number of cards of two different colors, each color corresponding to one of the two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
A trained nurse, blinded to patient group assignments, will measure intraocular pressure and administer treatment adherence and vision-related quality of life questionnaires.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Zabol University of Medical Sciences
Street address
Educational Complex, Zabol University of Medical Sciences, Shahid Rajaee Street, Zabol, Sistan and Baluchestan, Iran
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861615881
Approval date
2025-08-11, 1404/05/20
Ethics committee reference number
IR.ZBMU.REC.1404.058

Health conditions studied

1

Description of health condition studied
Glaucoma
ICD-10 code
H40
ICD-10 code description
Glaucoma

Primary outcomes

1

Description
Intraocular pressure
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
By TOPCON KR-8900 device

Secondary outcomes

1

Description
Treatment adherence
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Treatment adherence assessment questionnaire

2

Description
Vision-related quality of life
Timepoint
Before the intervention and eight weeks after the intervention
Method of measurement
Vision-related quality of life assessment questionnaire

Intervention groups

1

Description
Intervention group: The intervention group will receive four individual training sessions based on the Leventhal model, covering disease identity, etiology, consequences, course, and management. Social and cultural factors influencing patients' understanding will also be addressed and modified as needed.
Category
Rehabilitation

2

Description
Control group: The control group will receive standard glaucoma education.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Al-Zahra Ophthalmology Hospital, Zahedan
Full name of responsible person
BiBi Mahdie Khodadadi Hosseini
Street address
Al-Zahra Ophthalmology Hospital (S), Motahari Blvd., Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Email
mahdiekhodadadi.mk@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Abdolhossein Miri
Street address
Educational Complex of Zabol University of Medical Sciences, First Floor (Deputy for Research and Technology), Shahid Rajaee Street, Health Crossroads, Zabol, Sistan and Baluchestan Province
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
98616615881
Phone
+98 54 3223 0768
Fax
+98 54 3223 0770
Email
Research@zbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zabol 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
Zabol University of Medical Sciences
Full name of responsible person
BiBi Mahdie Khodadadi Hosseini
Position
Master's student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-Zahra Ophthalmology Hospital (S)., Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Email
mahdiekhodadadi.mk@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
Mahin Naderi Far
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ferdowsi Street
City
Zabol
Province
Sistan-va-Balouchestan
Postal code
9861734184
Phone
+98 54 3222 3947
Email
mahinaderifar@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zabol University of Medical Sciences
Full name of responsible person
BiBi Mahdie Khodadadi Hosseini
Position
Master's student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Al-Zahra Ophthalmology Hospital (S)., Motahari Blvd
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816737789
Phone
+98 54 3321 9915
Email
mahdiekhodadadi.mk@gmail.com

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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All data on intraocular pressure, treatment adherence, and vision-related quality of life of patients will be collected anonymously and sent to other researchers via email upon request.
When the data will become available and for how long
Patient data can be sent after the project article is published (end of 2026).
To whom data/document is available
Academic and scientific researchers
Under which criteria data/document could be used
Data use is permitted for research and therapeutic purposes.
From where data/document is obtainable
Al-Zahra Ophthalmological Hospital (S), Motahari Blvd.,Zahedan. Bibi Mahdieh Khodadadi Hosseini mahdiekhodadadi.mk@gmail.com
What processes are involved for a request to access data/document
To access the information, please send your request to me via email. After receiving the request, I will make the necessary arrangements with the Vice President of Research and Technology at Zabol University of Medical Sciences. If there is no legal prohibition, I will send the data to you via email.
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