The effect of self-management education through a mobile application on patient's self-efficacy and patient's adherence to medication after liver transplantation
Determining the effect of self-management training through mobile software on self-efficacy and drug adherence of patients after liver transplantation
Design
A clinical trial with a control group with parallel, single-blind, randomized block randomized groups that will be performed on 62 patients.
Settings and conduct
The project will be carried out in Bu Ali Sina Hospital in Shiraz. Initially, after providing oral explanations about the objectives of the study and the method of work, informed consent is obtained and questionnaires of self-efficacy and adherence to treatment will be provided to participants in both groups as a pre-test. Then, the pre-prepared educational materials, which include self-management training for liver transplant patients, are provided to the intervention group in the form of mobile software that has been approved by the professors of the School of Nursing and Electronics of Shiraz University of Medical Sciences and on the mobile phone. Or their tablet will be installed and they will be explained how to work with the software. In order to blind, the study of distribution and collection of questionnaires and data analysis will be done by people who do not know about the distribution of samples in groups
Participants/Inclusion and exclusion criteria
The patient is in the age range of 18-60 years.
The patient has a smart phone and is able to use mobile software.
Intervention groups
Patients who meet the inclusion criteria will be selected and entered into the study and will be divided into two groups of intervention and control. The intervention group will receive self-management training via mobile phone and routine nursing training will be provided for the control group.
Main outcome variables
Self-efficacy ; adherence to treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210220050427N1
Registration date:2021-09-15, 1400/06/24
Registration timing:retrospective
Last update:2021-09-15, 1400/06/24
Update count:0
Registration date
2021-09-15, 1400/06/24
Registrant information
Name
maryam keyvani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3257 3907
Email address
maryam.keyvani.ah@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-10, 1400/05/19
Expected recruitment end date
2021-08-31, 1400/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-management education through a mobile application on patient's self-efficacy and patient's adherence to medication after liver transplantation
Public title
The effect of self-management training on self-efficacy and adherence to medication of patients after liver transplantation
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient be in the age range of 18-60 years.
The patient must have a smart phone and be able to use mobile software.
Be able to understand and speak Persian.
Do not have a life-threatening illness.
Only received a liver transplant.
Exclusion criteria:
Do not use educational software in the intervention group.
Death of the patient.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
62
Randomization (investigator's opinion)
Randomized
Randomization description
Random Block Division Selects blocks of people and distributes treatment randomly among them.We select blocks of people and distribute treatment in them randomly, for example, we group the population into 6 to 6 and in each group we distribute the treatments randomly. In this way, the number of people in the group increases gradually and evenly.
Blinding (investigator's opinion)
Single blinded
Blinding description
In order to blind, the study of distribution and collection of questionnaires and data analysis will be done by people who do not know about the distribution of samples in groups.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Fatemeh School of Nursing and Midwifery.Namazi Hospital,Namazi Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2021-01-08, 1399/10/19
Ethics committee reference number
IR.SUMS.REC.1399.1112
Health conditions studied
1
Description of health condition studied
Self-efficacy and adherence to treatment of patients after liver transplantation.
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-efficacy score in the self-efficacy questionnaire
Timepoint
Before the intervention and three months after
Method of measurement
Self-efficacy questionnaire
2
Description
Adherence to medication
Timepoint
Before the intervention and three months after
Method of measurement
BAASIS Adherence Questionnaire
Secondary outcomes
1
Description
Self-efficacy score in relation to managing their behaviors
Timepoint
Before the intervention and three months after
Method of measurement
Self-efficacy questionnaire
2
Description
General self-efficacy score
Timepoint
Before the intervention and three months after
Method of measurement
Self-efficacy questionnaire
3
Description
Self-efficacy score in relation to achieving the desired result
Timepoint
Before the intervention and three months after
Method of measurement
Self-efficacy questionnaire
Intervention groups
1
Description
The intervention group is patients after liver transplantation who receive self-management training via mobile phone.
Category
Behavior
2
Description
The control group is patients after liver transplantation who will receive routine nursing training
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Abu Ali Sina Hospital
Full name of responsible person
Maryam Keyvani
Street address
Towards Dukohak, Phase 2, Sadra New City, Fars, Shiraz
City
Shiraz
Province
Fars
Postal code
54937-71649
Phone
+98 71 3344 0000
Fax
Email
bualisinacharity@gmail.com
Web page address
http://abualisina.net/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor. Younes Ghasemi
Street address
The central building of Shiraz University of Medical science, In front of Palestine St, Zand St, Shiraz, Fars
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3212 2713
Fax
+98 71 3230 8200
Email
info@sums.ac.ir
Web page address
https://www.sums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Doctor.Marzieh Momen Nasab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
7136474254-80098
Email
momennasab@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Doctor. Marzieh Momen Nasab
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Fatemeh School of Nursing and Midwifery.Namazi Hospital,Namazi Square
City
Shiraz
Province
Fars
Postal code
711936-13119
Phone
7136474254-80098
Email
momennasab@sums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Keyvani
Position
Master student of adult intensive care nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Fatemeh School of Nursing and Midwifery, Namazi Hospital, Namazi Square
City
Shiraz
Province
Fars
Postal code
71936-13119
Phone
+98 38 3257 3907
Email
maryamkeyvani.ah@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
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
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Obtaining an official letter of introduction from Hazrat Fatemeh School of Midwifery and Nursing in Shiraz and obtaining permission from the officials of Shiraz University of Medical Sciences. Obtaining written consent from the samples to participate in the study. - Assuring the research units about the confidentiality of the information received. - Participate freely and completely voluntarily in the research samples and considering the right to withdraw from the research. - Creating a private environment for interviewing the patient and completing a questionnaire. Provide the results of the research if desired by the training center where the researcher has sampled
When the data will become available and for how long
After studying and printing the results
To whom data/document is available
Private and public hospitals, liver transplant centers and training centers where the researcher has sampled
Under which criteria data/document could be used
Obtaining permission from the relevant officials in the faculty, university and hospital. - Keeping participants' information confidential.
From where data/document is obtainable
Shiraz. Zand St., Library of Shiraz School of Nursing and Midwifery. Mr. Ghasemi's library manager. Phone:00987136474254
What processes are involved for a request to access data/document
The request for the results will be sent to the library of Shiraz School of Nursing and Midwifery. It will be provided to them with the coordination done.