Protocol summary

Study aim
Comparison of the Effect of face to face training and self-care software under smart phones on the quality of life of patients with liver cirrhosis
Design
In this research, 60 eligible patients with liver cirrhosis, referring to Imam Reza and Ghaem hospitals were chosen purposefully and a code was allocated to each one of them. Then, patients in a minimization method were divided into two control and software groups.
Settings and conduct
The study is done in two parts. The first part is the provision of the content of the software and its production. In the second part, 60 patients with liver cirrhosis referring to Ghaem Hospital and Imam Reza Hospital and specialized liver clinics in Mashhad were selected according to entry criteria and divided into two groups. the patients in the software group will have a 45-minute individual training session on how to install the software and work with it, and for the control group, there are two 45-minute face-to-face sessions. Both groups are followed up for a month. Quality of life questionnaire before the intervention, two weeks and four weeks after the intervention, will be completed in two groups and at the end of the data analysis will be done.
Participants/Inclusion and exclusion criteria
Participants must have ages 20-65 years, access to Android smartphone, and have the skills to use it, AND not participate in the previous self-care program, and not be candidates for the Transplant. If the patient has such cases as death, candidation for transplantation or exacerbation of the disease, will be excluded FROM the study .
Intervention groups
Intervention on liver cirrhosis patients admitted to the hospital or referring to the office which has entry criteria, will begin with available sampling method and random allocation will be made to the software and comparison groups. the patients in the software group will have a individual training session on how to install the software and work with it, and will give them a booklet on how to use the software. The comparison group will receive the equivalent educational content in two session in face-to-face manner, and during the training, a question and answer will be made between the researcher and the patient, as needed. further information will be provided as a pamphlet to the patient. Patients are followed up by researcher, as a weekly phone call for a period of one month.
Main outcome variables
Quality of Life

General information

Reason for update
Acronym
does not have
IRCT registration information
IRCT registration number: IRCT20171030037098N1
Registration date: 2017-11-22, 1396/09/01
Registration timing: registered_while_recruiting

Last update: 2017-11-22, 1396/09/01
Update count: 0
Registration date
2017-11-22, 1396/09/01
Registrant information
Name
علیه ولی زاده
Name of organization / entity
دانشگاه علوم پزشکی مشهد
Country
Iran (Islamic Republic of)
Phone
+98 51 3723 6287
Email address
valizadeha941@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-11, 1396/08/20
Expected recruitment end date
2018-01-10, 1396/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of smart phone self-care application on quality of life in patients with liver cirrhosis
Public title
Effect of self care program on liver cirrhosis quality of life
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has definitive diagnosis of cirrhosis of the liver in steps A and B of the Childe classification. Aged 20-65. Has not participated in the previous or current self-care program. Access to Android smartphone. The use of the smartphone literacy Patient is not a candidate for a transplant.
Exclusion criteria:
The patient's death occurs. The patient should be bonded during the research.
Age
From 20 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
In this research,the minimization method is used. In which patients were examined for three characteristics of age, gender and economic status, one person in the control group and one in the software group from both the same person.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is one-way blind. In this study, patients without knowing what they are supposed to be and in what group are randomly divided into two groups and that they are not known to be in the control group or intervention.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
The Ethics Committee of Mashhad University of Medical Sciences
Street address
Quraishi Building, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
91375345
Approval date
2017-10-07, 1396/07/15
Ethics committee reference number
IR.MUMS.REC.1396.190

Health conditions studied

1

Description of health condition studied
Cirrhosis of the liver
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of Life
Timepoint
Zero, two weeks, one month
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Provide educational software under the Android operating system and provide it to the patient
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
aliyyeh vali zadeh
Street address
daneshgah
City
mashhad
Province
Razavi Khorasan
Postal code
9184911111
Phone
+98 51 3802 2000
Email
valizadeha941@mums.ac.ir

2

Recruitment center
Name of recruitment center
Ghaem Hospital
Full name of responsible person
aliyyeh vali zadeh
Street address
Ahmad abad
City
mashhad
Province
Razavi Khorasan
Postal code
9184911111
Phone
+98 51 3840 0000
Email
valizadeha941@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Robab Latifnezhad
Street address
University Street, Dr. Crossroads, Ibn Sina St
City
mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
valizadeha941@mums.ac.ir
Grant name
Grant code / Reference number
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
Aliyyeh Vali zadeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
valizadeha941@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vali zadeh, Aliyyeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
valizadeha941@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Vali zadeh, Aliyyeh
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Ibn Sina Avenue, Doctor's Crossroads, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
valizadeha941@mums.ac.ir

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
Not applicable
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