Cluster randomized controlled trial: Evaluating the effectiveness of a quasi-documentary film in the process of patient education in patients who are candidates for radioactive iodine treatment and their companions
Determining the effectiveness of the cinemeducation tool in the form of a quasi-documentary film in the process of patient education in patients who are candidates for radioactive iodine treatment and their companions.
Design
A factorial cluster randomized trial with three groups of 70 participants who were randomly divided into three groups using Block Stratified Randomization Windows version 6.0 software.
Settings and conduct
The comparison of the effects of these methods is done with the help of questionnaires in the three areas of remembering key knowledge and awareness (multiple choice), patient satisfaction (Likert scale) and the patient's objective performance from the perspective of health care providers (Likert scale). These effects are evaluated in three functional sections of pre-treatment preparations, hospitalization activities, and post-treatment follow-ups and care.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with differentiated thyroid cancer after total thyroidectomy who are candidates for radioactive iodine treatment and their companions.
Exclusion criteria: Having a previous history of radioiodine therapy.
Intervention groups
The first group watches the quasi-documentary along with the usual patient education methods.
The second group only watches the pseudo-documentary film.
The third group only uses the usual "patient education" methods.
Main outcome variables
Remembering key knowledge and awareness in the three sections of pre-treatment preparations, hospitalization activities, and post-treatment follow-ups and care.
Patient satisfaction and perceived usefulness of the items taught.
The objective performance of patients in correctly performing the taught items.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240627062263N1
Registration date:2024-07-05, 1403/04/15
Registration timing:prospective
Last update:2024-07-05, 1403/04/15
Update count:0
Registration date
2024-07-05, 1403/04/15
Registrant information
Name
Mohammad Mobin Moradi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 3010
Email address
mm-moradi@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-07-06, 1403/04/16
Expected recruitment end date
2024-09-06, 1403/06/16
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cluster randomized controlled trial: Evaluating the effectiveness of a quasi-documentary film in the process of patient education in patients who are candidates for radioactive iodine treatment and their companions
Public title
Evaluating the effectiveness of a quasi-documentary film in the process of patient education
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with differentiated thyroid carcinoma (DTC) who are candidates for radioactive iodine treatment after total thyroidectomy
Companions of patients with differentiated thyroid carcinoma (DTC) who are candidates for radioactive iodine treatment after total thyroidectomy
Exclusion criteria:
Having a previous history of radioiodine therapy
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
210
Randomization (investigator's opinion)
Randomized
Randomization description
The patients have already been randomly divided into two groups by a statistician using the Block Stratified Randomization Windows version 6.0 software, and their randomization form has been provided to the researcher.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, according to the intervention that broadcasts a quasi-documentary film to carry out the process of patient education; the researcher, the outcome assessor, and the data analyst were blinded, and the patient and the clinical caregiver who was responsible for educating the patient were not blinded.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee of Shariati Hospital
Street address
Shariati Hospital, North Kargar st.
City
Tehran
Province
Tehran
Postal code
1411713135
Approval date
2023-07-23, 1402/05/01
Ethics committee reference number
IR.TUMS.SHARIATI.REC.1402.073
Health conditions studied
1
Description of health condition studied
Differentiated thyroid carcinoma
ICD-10 code
C73
ICD-10 code description
Malignant neoplasm of thyroid gland
Primary outcomes
1
Description
Reserved key knowledge and awareness (remembered)
Timepoint
Before the intervention and after the intervention and also at the first follow-up visit.
Method of measurement
Multiple-choice questionnaire to assess the level of reserved knowledge and awareness (remembered) in three sections: preparations before treatment, activities during hospitalization and follow-ups and care after treatment.
2
Description
The scale of satisfaction and perceived usefulness (the patient's perception of the usefulness from the patient education process)
Timepoint
At the end of the study
Method of measurement
Satisfaction and perceived usefulness questionnaire on the Likert scale
3
Description
Scale of patient's objective performance
Timepoint
Before the intervention and after the intervention, as well as at the first follow-up visit
Method of measurement
A Likert scale questionnaire of the patient's objective performance level from the point of view of the health care providers in three sections; preparations before treatment, activities during hospitalization and follow-ups and care after treatment.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The first group receives knowledge related to patient education both through a quasi-documentary educational film and the usual methods of patient education.
Category
N/A
2
Description
Intervention group: The second group receives knowledge related to patient education only through educational quasi-documentary films.
Category
N/A
3
Description
Control group: The control group receives tips related to patient education only through the usual methods of patient education.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital
Full name of responsible person
Mohammad Mobin Moradi
Street address
Shariati hospital, North Kargar St.
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
m.mobin.moradi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir
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
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mobin Moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Nuclear Medicine
Street address
North Kargar St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6691 0317
Email
m.mobin.moradi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mobin Moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Nuclear Medicine
Street address
North Kargar St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6691 0317
Email
m.mobin.moradi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Mobin Moradi
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Nuclear Medicine
Street address
North Kargar St.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 6691 0317
Email
m.mobin.moradi@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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The quasi-documentary film file that was used as an intervention in this study will be available in physical form in the nuclear medicine department of Shariati Hospital after the end of the study, and it will also be published on online platforms that will be determined later.
When the data will become available and for how long
At the end of the study.
To whom data/document is available
Everyone.
Under which criteria data/document could be used
There is no precedent
From where data/document is obtainable
Shariati Hospital and will also be uploaded on online platforms that will be specified later.
What processes are involved for a request to access data/document
To have the file of the movie, people should go to the secretary of the nuclear medicine department of Shariati Hospital or to the online platform that will be announced later.