Comparing the Effect of Face-to-Face Training and Use of a Mobile Application on Treatment Adherence to Hemodialysis Patients
Design
The randomized, two-stage, two-group clinical trial consisted of two intervention groups with a sample size of 70 patients. Randomization is done using a table of random numbers.
Settings and conduct
This clinical trial is performed in a hospitals in Isfahan. The target group is patients undergoing hemodialysis. Treatment adherence is assessed by three methods: questionnaire, laboratory results and mean weight gain between dialysis sessions, before and after the educational intervention. Blinding is done only for the data analyzer.
Participants/Inclusion and exclusion criteria
Inclusion criteria: having cell phone with Android OS; having hemodialysis sessions 3 times a week.
Exclusion criteria: transfer the patient to other centers or kidney transplant during the study; absence from training sessions for more than 3 sessions.
Intervention groups
Intervention group 1:
In the face-to-face training group, the contents prepared for the educational applications will be transferred to the patients in person by the researcher. Training will be 4 weeks, 3 sessions per week for at least 10 minutes. At the end of each week session, the taught contents will be delivered in writing to the patients.
Intervention group 2:
In the mobile application group, 90 educational messages with different topics are provided to the patient. Daily 3 educational messages with 3 different topics and without repetition will be displayed for the patient. Therefore, the samples of this group will be trained daily for at least 10 minutes. In the application, it is possible to select medicines reminder and there will be a possibility of weekly self-examination for the patient.
Main outcome variables
Treatment Adherence to Hemodialysis Patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171216037895N5
Registration date:2021-04-28, 1400/02/08
Registration timing:prospective
Last update:2021-04-28, 1400/02/08
Update count:0
Registration date
2021-04-28, 1400/02/08
Registrant information
Name
Mohsen Torabi Khah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 3071
Email address
m.torabikhah@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-22, 1400/04/01
Expected recruitment end date
2021-07-23, 1400/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effect of Face-to-Face Training and the Use of a Mobile Application on the Treatment Adherence to Hemodialysis Patients
Public title
The effect of Face-to-Face training and mobile educational application on treatment adherence to hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Willing to participate in the study
Be older than 18 years old
Having the ability to read and write
Having cell phone with Android operating system
Not having any disability that makes it difficult to receive training
Presence in the research environment as a permanent patient
Having hemodialysis sessions 3 times a week
Do not use other educational application about hemodialysis during the study
Perform hemodialysis for at least 6 months
Not suffering from mental illness or other advanced chronic diseases such as chronic heart failure
Exclusion criteria:
Refusing to being in the study
Transfer the patient to other centers or kidney transplant during the study
Do not use the application for more than 1 week
Absence from face-to-face training sessions for more than 3 sessions
Improper performance of the application on the patient's mobile phone
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
After reaching the desired sample size, the researcher uses a table of random numbers to allocate the samples randomly in two groups of face-to-face training and educational application. For face-to-face training group, odd numbers and for training by application, even numbers are considered. The researcher then randomly touches one of the numbers in the list of random numbers and moves upwards. By matching the patient list and the numbers obtained, random allocation will continue until the desired sample size is reached.
Blinding (investigator's opinion)
Single blinded
Blinding description
All data from the study will be provided to the data analyzer in the form of numbers so that he is not aware of the type of grouping. In this way, face-to-face training group is considered as group 1 and mobile phone application is as group 2.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the AJA University of Medical Sciences
Street address
West Fatemi St., Etemadzadeh St.
City
Tehran
Province
Tehran
Postal code
1411718541
Approval date
2021-04-20, 1400/01/31
Ethics committee reference number
IR.AJAUMS.REC.1400.006
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18
ICD-10 code description
Chronic kidney disease (CKD)
2
Description of health condition studied
Hemodialysis
ICD-10 code
Z49.01
ICD-10 code description
Encounter for fitting and adjustment of extracorporeal dialysis catheter
Primary outcomes
1
Description
Treatment adherence
Timepoint
One week before the beginning of the intervention, immediately and 8 weeks after the end of the intervention
Method of measurement
Questionnaire, laboratory values, measurement of overweight between hemodialysis sessions
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: in the face-to-face training group, the contents prepared for the educational applications will be transferred to the patients in person by the researcher. Training will be 4 weeks, 3 sessions per week for at least 10 minutes. At the end of each week session, the taught contents will be delivered in writing to the patients
Category
Lifestyle
2
Description
Intervention group: in the mobile application group, 90 educational messages with different topics are provided to the patient. Training topics include the importance of hemodialysis, management of hemodialysis complications, diet, fluid restriction, physical activity, vascular access care, and medication. Daily 3 educational messages with 3 different topics and without repetition will be displayed for the patient. Therefore, the samples of this group will be trained daily for at least 10 minutes. In the application, it is possible to select medicines reminder and there will be a possibility of weekly self-examination for the patient.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Hojjat bin al-Hassan al-Askari Hospital (Hojjatieh)
Full name of responsible person
Mohammad-reza Kajani
Street address
Qaem Magham Farahani St., Sajjad St
City
Isfahan
Province
Isfehan
Postal code
8166737353
Phone
+98 31 3630 6001
Email
info@hajjat-hospital.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Sanaz Zargar Balaye Jame
Street address
West Fatemi St., Etemadzadeh St.,
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 8609 6350
Email
info@ajaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Artesh 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
Artesh University of Medical Sciences
Full name of responsible person
Zahra Farsi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Shariati St. - Kaj St. - Army School of Nursing
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 7760 1533
Email
zahrafarsi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Zahra Farsi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Dr. Shariati St. - Kaj St. - Army School of Nursing
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 7760 1533
Email
zahrafarsi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Artesh University of Medical Sciences
Full name of responsible person
Mohsen Torabi Khah
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Dr. Shariati St. - Kaj St. - Army School of Nursing
City
Tehran
Province
Tehran
Postal code
1411718541
Phone
+98 21 7760 1533
Email
mohsentorabikhah@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available