Designing and assessing the effectiveness of hemodialysis application and its care on health literacy and treatment adherence in patients undergoing hemodialysis
Determining the effectiveness of hemodialysis application and its care on health literacy and adherence to treatment in hemodialysis patients
Design
A community-based, pragmatic, control group clinical trial was randomized with parallel groups.
Settings and conduct
Training on how to use the hemodialysis application will be given to patients and their first-degree companions in one of the hemodialysis rooms of hospitals affiliated to Kashan University of Medical Sciences. Then, they will be emphasized that every day at home for 6 weeks to study and review of the application.
Participants/Inclusion and exclusion criteria
Inclusion criteria are: Hemodialysis patients in the age range of 18 to 65 years who are literate, and have the ability to use mobile. No entry conditions: Reluctance to cooperate
Intervention groups
At the beginning of the research, the hemodialysis application and its care will be designed by the research researchers. Then the application will be installed on the mobile of the intervention group and their first-class companions. Patients will be instructed to read and review the content in the application every day. The researcher will contact the patient on Saturdays and Tuesdays each week and remind them to read the contents of the application. This process will continue for up to 6 weeks. In the control group, there will be no intervention and they will receive routine care (medication).
Main outcome variables
Health literacy ; Adherence to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210525051400N1
Registration date:2021-06-06, 1400/03/16
Registration timing:prospective
Last update:2021-06-06, 1400/03/16
Update count:0
Registration date
2021-06-06, 1400/03/16
Registrant information
Name
Seyyed Hossein Hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8845 1143
Email address
hosseini.h8680@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-18, 1400/03/28
Expected recruitment end date
2021-07-19, 1400/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Designing and assessing the effectiveness of hemodialysis application and its care on health literacy and treatment adherence in patients undergoing hemodialysis
Public title
The effectiveness of hemodialysis application in hemodialysis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who undergo hemodialysis three times a week for 4 hours each time
Be literate
Be between 18 and 65 years old
At least 3 months have passed since the start of hemodialysis
Smart phones have Android operating system
Be able to work with smart phones
Exclusion criteria:
Reluctance to cooperate and participate in the study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation in the two groups of intervention and control uses the method of random blocks (6 blocks of 10 people) using software.
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
Ethics Committee of Kashan University of Medical Sciences
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Approval date
2021-05-24, 1400/03/03
Ethics committee reference number
IR.KAUMS.NUHEPM.REC.1400.003
Health conditions studied
1
Description of health condition studied
Hemodialysis patients
ICD-10 code
Z49
ICD-10 code description
Encounter for care involving renal dialysis
Primary outcomes
1
Description
Health literacy
Timepoint
Before, immediately after the end of the study and one month later
Method of measurement
Health literacy for Iranian Adults
2
Description
Adherence to treatment
Timepoint
Before, immediately after the end of the study and one month later
Method of measurement
Questionnaire of adherence to the treatment of patients with end-stage renal disease
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: First, the hemodialysis application will be installed on the mobile phones of patients and their first-class companions. Patients will be instructed to read and review the content in the application every day at home. The researcher will contact the patient on Saturdays and Tuesdays each week and remind them to read the contents of the application. This process will continue for up to 6 weeks.
Category
Prevention
2
Description
Control group: There will be no intervention and they will receive routine care (medication).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hospitals affiliated to Kashan University of Medical Sciences
Full name of responsible person
Seyed Hossein Hosseini
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
hosseini.h8680@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Hamid Reza Banafsheh
Street address
Vice Chancellor of Research & Technology, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
banafshe_h@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan 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
Kashan University of Medical Sciences
Full name of responsible person
Mahboubeh Rezaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
m4.rezaei@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahboubeh Rezaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
m4.rezaei@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Mahboubeh Rezaei
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Kashan university of medical sciences, Parastar St., Qotbe Ravandi Blv, Kashan, Iran
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 5554 0021
Email
m4.rezaei@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