Investigating the effect of treatment reminder application on treatment adherence in adults with thalassemia major
Design
A randomized clinical trial with a control group is conducted with parallel groups on 80 patients. Randomization is conducted with the help of permutations and random library.
Settings and conduct
This research is carried out in Sarvar clinic in Mashhad. The random sequence method will be used in the block method. The intervention group will use an offline app for 8 weeks. The control group will not receive this app. Before and after the intervention, a questionnaire is used to check compliance with the treatment
Participants/Inclusion and exclusion criteria
Included
thalassemia major with aged 18 years and older
Having an active smartphone
They have sufficient skills in Farsi or English to work with a smartphone and the ability to use it
They do not have mental illness and hearing and vision problems
informed consent
Exclusion
Patients were excluded if they themselves used a medication reminder app for example calendar alerts on their phones.
Patients with smartphones that are unable to download apps
If a person reports not using the reminder program in two phone calls by the researcher, he will be excluded from the study.
Patients who do not want to continue cooperation
Intervention groups
The intervention group will use an offline app for 8 weeks. The control group will not receive this app.
Main outcome variables
Adherence to treatment
Medication Adherence
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240222061079N1
Registration date:2024-03-04, 1402/12/14
Registration timing:prospective
Last update:2024-03-04, 1402/12/14
Update count:0
Registration date
2024-03-04, 1402/12/14
Registrant information
Name
Mahdieh Arian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3768 9730
Email address
shadi1aramesh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-08-26, 1403/06/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of therapy reminder application on therapy-adherence in adult with Beta thalassemia major patients
Public title
Effect of therapy reminder application on therapy-adherence
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1- Patients with thalassemia major aged 18 years and older who have an active file in Sarwar Clinic and are being treated with blood transfusion and iron removal drugs
2- Having an active smartphone that works with the Android operating system,
3- They have sufficient skills in Farsi or English to work with a smartphone and the ability to use it
4- They do not have mental illness and hearing and vision problems (due to hearing and seeing application alarms)
5- Provide written informed consent to participate in the research.
Exclusion criteria:
1- Patients were excluded if they themselves used a medication reminder app or other electronic reminder systems to adhere to their medication regimen, for example calendar alerts on their phones.
2- Patients with smartphones that are unable to download apps are excluded.
3- If a person reports not using the reminder program in two phone calls by the researcher, he will be excluded from the study.
4- Patients who do not want to continue cooperation for any reason will be excluded from the study during the study period.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation will be done with Python version 3 with the help of permutations and random library. These two libraries will be used to generate a random sequence using the block method (here, blocks of 4 and 2 are used that will be randomly generated and randomly generate the sequence). In order to hide, before assigning the person, the assigned group will not be known. It is organized using a sealed opaque envelope with a random allocation sequence. Each of the generated random sequences is recorded on a card and the cards are placed in the envelopes in order. In order to maintain the random sequence, the outer surface of the envelopes will be numbered in the same order. Finally, the lids of the envelopes are glued and placed in a box respectively. At the time of registration, based on the order in which the eligible participants entered the study, one of the envelopes will be opened and the assigned group of that participant will be revealed .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
دانشکده پرستاری و مامایی مشهد
Street address
Khorasan Razavi, Azadi Square, east gate of Ferdowsi University of Mashhad, university campus, educational complex of Shahid Dr. Kharazmi
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-02-06, 1402/11/17
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.116
Health conditions studied
1
Description of health condition studied
Major Thalassaemia
ICD-10 code
D56.1
ICD-10 code description
Beta thalassemia
Primary outcomes
1
Description
Adherence to treatment
Timepoint
Before and after the intervention (8 weeks apart)
Method of measurement
Moriski questionnaire and chronic patient treatment adherence questionnaire
Secondary outcomes
1
Description
Evaluation of the designed application
Timepoint
Once designed
Method of measurement
Application evaluation questionnaire
Intervention groups
1
Description
Intervention group: Using an offline app for 8 weeks
Category
Behavior
2
Description
Control group: They receive routine treatment without an app
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Sarvar Specialized Polyclinic affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Arian
Street address
No. 32, 6 Sajidi Fadak Crossroads, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196816353
Phone
+98 51 3768 9730
Email
arianyem@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Khorasan, Razavi, Mashhad, University St., next to Hoize Cinema, Qurashi Building, Research and Technology Vice-Chancellor
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Arian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 32, 6 Sajidi Fadak Crossroads, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196816353
Phone
+98 51 3768 9730
Email
arianyem@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Arian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 32, 6 Sajidi Fadak Crossroads, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196816353
Phone
+98 51 3768 9730
Email
arianyem@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahdieh Arian
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
No. 32, 6 Sajidi Fadak Crossroads, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9196816353
Phone
+98 51 3768 9730
Email
arianyem@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
Yes - There is 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
Complete information such as: work method, implementation, informed consent, analysis and analysis results will be shared in the article after the work is completed.
When the data will become available and for how long
after finishing the work
To whom data/document is available
Researchers and patients can have access by receiving an article or thesis
Under which criteria data/document could be used
For research and educational work
From where data/document is obtainable
E-mailing the researcher or downloading articles from reputable sites
What processes are involved for a request to access data/document
E-mailing the researcher or downloading articles from reputable sites