Design, implementation, and evaluation of educational intervention through the patient decision making aid (PDA) to select correction method for patients with myopia
Evaluating the effect of educational intervention through patient decision aid (PDA) in choosing corrective laser surgery
Design
A clinical trial with a control group, with parallel groups, randomized by quadruple block method is performed on 30 patients as a control group and 30 myopic patients as a control group. Patients' knowledge and decision to choose the method of laser myopia correction is evaluated using the patient decision-making aid before and after using the guide aid. The intervention includes three phases: pre-test, content training, and post-test. Pre-test in both intervention and control groups is sent to their mobile phone in the form of an online questionnaire including evaluation of emotion, knowledge, and decision stage. The link of the website designed for the patients of the intervention group, ie the patients who are candidates for three surgical methods, will be sent and the way of working with the aid will be explained. Each person has access to educational content for 48 hours at any time and place. At the end of 48 hours, access to the educational content is automatically disabled. At the end of the tooling process, pre-test questions are asked again. During the use of the tool, the intervention group proceeds through 5 decision stages, respectively, and without passing one stage, they are not able to enter the next stage.
Settings and conduct
The study will be performed in the ophthalmologist's office in Tehran.
Participants/Inclusion and exclusion criteria
Have enough vision to browse PDA
Literate
Age 14 to 40
Candidate for Small Incision Lenticule Extraction, Laser-Assisted in Situ Keratomileusis, Photorefractive keratectomy
Intervention groups
Eligible patients and recipients of a PDA for corrective laser surgery.The control group does not receive educational content through PDA
Main outcome variables
Decide on the selection type of laser correction
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191229045933N1
Registration date:2021-03-19, 1399/12/29
Registration timing:prospective
Last update:2021-03-19, 1399/12/29
Update count:0
Registration date
2021-03-19, 1399/12/29
Registrant information
Name
Hanieh Delshad-Aghdam
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 5943
Email address
hanieh.delshad@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-04, 1400/01/15
Expected recruitment end date
2021-05-05, 1400/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design, implementation, and evaluation of educational intervention through the patient decision making aid (PDA) to select correction method for patients with myopia
Public title
Effect of a patient decision aid to select for myopia correction surgery method
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
All patient with enough vision for reviewing the decision aid content
All Patient with enough literacy for reviewing the decision aid content
All Nearsighted patient proved by ophthalmologist and optometrist
Candidates for all three surgical procedures: Smile, Femto-LASIK and PRK
Exclusion criteria:
Patients have not received formal education on myopia correction
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the block (quadruple) randomization method will be performed. Thus, by referring to the hospital, the researcher identifies the eligible individuals to participate in the study and divides them into two experimental and control groups by random allocation by quadruple block method. It considers the letter A for the intervention group and the letter B for the control group. Then all the permutation combinations of the letters AA and BB, which are six different combinations, and from combinations 1 to 6, one combination is randomly selected. This operation continues continuously until the 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
Trabiat Modares University
Street address
Jalal Al-Ahmad St., Nasr Bridge, Tarbiat Modares University, School of Medicine
City
Tehran
Province
Tehran
Postal code
111-14115
Approval date
2019-11-27, 1398/09/06
Ethics committee reference number
IR.MODARES.REC.1398.212
Health conditions studied
1
Description of health condition studied
Myopia
ICD-10 code
H52.13
ICD-10 code description
Myopia, bilateral
Primary outcomes
1
Description
Knowledge of laser correction methods for myopia
Timepoint
48 after educational intervention
Method of measurement
Through knowledge assessment questions about the three eye surgery methods listed in the patient decision aid
2
Description
The patient's decision in choosing the method of laser surgery for myopia
Timepoint
48 after educational intervention
Method of measurement
From the decision assessment questions of choosing the surgical method, contained in the patient decision aid
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention includes three phases: pre-test, content training, and post-test. The test is sent to their mobile phone in the form of an online questionnaire including assessment of feelings, knowledge and decision stage. The link of the website designed for the patients of the intervention group, i.e. the patients who are candidates for three surgical methods, will be sent and the way of working with the tool will be explained to the people. Each person has access to educational content for 48 hours at any time and place. At the end of 48 hours, access to the educational content is automatically disabled. At the end of the process of using the tool, pre-test questions are asked again.
Category
N/A
2
Description
Control group: The test is sent to their mobile phone in the form of an online questionnaire including evaluation of feelings, knowledge and decision stage. This group does not receive any training. At the end of the educational intervention, they receive a post-test questionnaire.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Farabi Eye Hospital
Full name of responsible person
Hanieh Delshad-Aghdam
Street address
Nofel Loshato St., not far from Hafez Bridge, Shahrokh Alley, No. 50, 4th floor
City
Tehran
Province
Tehran
Postal code
1131635817
Phone
+98 21 6670 5943
Email
hanieh.delshad@modares.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Trabiat Modares University
Full name of responsible person
Yaghoub Fatollahi
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
City
Tehran
Province
Tehran
Postal code
14115111
Phone
+98 21 8288 4546
Email
hanieh.delshad@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Trabiat 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
2
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Seyed-Farzad Mohammadi
Street address
Kargar South, Qazvin Square, Farabi Hospital, Translation Ophthalmology Research Center
City
Tehran
Province
Tehran
Postal code
1336616351
Phone
+98 21 5541 6134
Email
delshad.np.on@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
TehranTarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
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
TehranTarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
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
TehranTarbiat Modares University
Full name of responsible person
Fatemeh Zarei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Health Promotion
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al-Ahmad St.
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Part of the data on the main consequences can be shared.
When the data will become available and for how long
Access period starts 6 months after the results are published
To whom data/document is available
The data will be available only to researchers working in academic and scientific institutions.
Under which criteria data/document could be used
Frequent measurement analysis to evaluate the effect of education and patient decision, 6 months after the 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 by the applicant to the email address of Dr. Fatemeh Zarei f.zarei@modares.ac.ir will be answered.