Determining the Effect of Mobile Health program on treatment adherence in adolescents with leukemia
Design
This research is a randomized clinical trial with an intervention and control group with a sample size of 70 people.
Settings and conduct
Sampling will be done based on the inclusion criteria after obtaining the relevant permits from relevant officials in hospitals.participants will be randomly assigned to the intervention and control groups.a written consent form will be obtained from candidate. For the intervention group, the researcher will install the App designed by the researcher and provide educational content and communicate with the teenagers through the app.In the control group, there will be no intervention.The research environment is chemotherapy clinics and oncology departments of Mofid, Shohada Tajrish, Ali Asghar Medical Centers.
Participants/Inclusion and exclusion criteria
Inclusion Criteria:Being able to read and write in Persian.Access to a smart phone.Living in a family and with one's biological parents.Age group 10 to 21 years old
Exclusion criteria:Not completing the questionnaire. Not using the application
Intervention groups
For the intervention group, it will be providing educational content and communicating with patients for eight weeks through the installation and implementation of an application designed by the researcher regarding the disease.The application was designed by a researcher and can be installed on teenagers' mobile phones. Through this application, teenagers can learn about the disease and adjust the time of taking their medicines, and the process of taking medicines is recorded in the application. Also, this application contains six chapters, the content of which will be appropriate and understandable for teenagers. Patients in the control group will have routine treatment and follow-up.
Main outcome variables
Adherence to drug treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161024030474N7
Registration date:2023-09-02, 1402/06/11
Registration timing:registered_while_recruiting
Last update:2023-09-02, 1402/06/11
Update count:0
Registration date
2023-09-02, 1402/06/11
Registrant information
Name
Azam Shirinabadi Farahani
Name of organization / entity
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21886553668
Email address
farahani1381@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Studying The Effect of Mobile Health Program on Adherence to Treatment in Adolescents with Leukemia
Public title
The Effect of Mobile Health Program on Adherence to Treatment in Adolescents with Leukemia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Being able to read and write in Persian
Access to a smartphone
Suffering from leukemia so that at least one year has passed since the diagnosis of the disease
Living in the family and with one's biological parents
Not having any other disease other than leukemia
Not being at the end of life
Age group 10-21 years
Giving informed consent
No history of participating in similar training classes
Exclusion criteria:
The occurrence of any incident that leads to the teenager becoming ill and being hospitalized, so that he is not able to continue cooperation
The occurrence of any incident that leads to discharge from the hospital or its change
Not completing the questionnaire
Not using the application
Age
From 10 years old to 21 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
In the current study, sampling will be done based on the inclusion criteria, and then the random allocation of the samples will be done using the simple randomization method to intervention and control group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Using the designed application is considered as the main intervention in this study.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Niayesh Intersection, Valiasr St., Tehran
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2023-06-20, 1402/03/30
Ethics committee reference number
IR.SBMU.PHARMACY.REC.1402.043
Health conditions studied
1
Description of health condition studied
Treatment adherence, Mobile Health, leukemia
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
treatment adherence
Timepoint
Before the intervention, after the intervention (eight weeks)
Method of measurement
Questionnaire of compliance with treatment Moriski et al
Secondary outcomes
empty
Intervention groups
1
Description
The purpose of the intervention is to use the application designed by the researcher for eight weeks. This application includes three parts of educational content, a warning system, and the ability to send messages, and its educational content are six chapters and will include: a definition of cancer and its cause, symptoms of cancer, chemotherapy drugs, and their side effects, as well as the recommendations of the nursing staff and training on how to adjust the time of taking drugs. Regarding the warning system, the samples can communicate with the researcher through the section designed to send messages in the application. In addition, a page has been designed for uploading photos, through which the patient can clarify the results of the tests or any questions and ambiguities by sending photos.
Category
Other
2
Description
Control group: Control group:No intervention will take place and the patients will receive their routine treatment plan.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tehran Children's Medical Center Hospital
Full name of responsible person
Mohammadreza Modaresi
Street address
No. 62, Dr. Mohammad Gharib St., end of Keshavarz Blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6692 2115
Email
modaresipul@gmail.com
2
Recruitment center
Name of recruitment center
Mofid Children Hospital
Full name of responsible person
Masome Hosseinpour
Street address
Shariati St., above Hosseinieh Irshad, before Mirdamad St.
City
Tehran
Province
Tehran
Postal code
1551415468
Phone
+98 21 2222 7021
Email
masomehosseinpour@gmail.com
3
Recruitment center
Name of recruitment center
Tajrish Shohadaye Hospital
Full name of responsible person
Dr. Farideh Mousavi
Street address
Tajrish Shohadaye Educational Medical Center., Shahadari St., Tajrish Square., Tehran.
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Cross-Section, ValiAsr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
sbnmf@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Shahid Behesht School of Nursing and Midwifery-near Niayesh crossroads - Valiasr St
City
tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
farahani1381@sbmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azam Shirinabadi Farahani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Cross-Section, ValiAsr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21886553668
Email
farahani1381@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masome Hosseinpour
Position
MSc Nursing Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Shahid Beheshti University of Medical Sciences, Niyayesh Cross-Section, ValiAsr St.
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8865 5366
Email
masomehosseinpour@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
Undecided - It is not yet known if there will be 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
There is no further information
When the data will become available and for how long
The access is possible 6 months after the results are published.
To whom data/document is available
Researchers, students, hospital staff
Under which criteria data/document could be used
For the purpose of study and research by referring to this study
From where data/document is obtainable
Contacting with: masomehosseinpour@gmail.com
What processes are involved for a request to access data/document
After sending an e-mail to the above-mentioned address, the maximum period of 1 month