Comparison of the cost-effectiveness of face-to-face and virtual healthy lifestyle training on the burden of care in caregivers of multiple sclerosis patients
Determining and Comparison of the cost-effectiveness of face-to-face and virtual healthy lifestyle training on the care burden of caregivers of MS patients
Design
A randomized controlled with a parallel group, single-blind, on 60 caregivers of MS patients referring to Ghaem Hospital.
Settings and conduct
The study environment is the MS clinic of Ghaem Hospital. In intervention group, the educational content is taught virtually through the Eitta messenger during 5 weeks in 5 sessions (45-60 minutes). In control group, the same educational content will be presented through lectures, group discussions in face-to-face sessions during 5 weeks in 5 sessions (45-60 minutes). Cost-effectiveness in each group is calculated and analyzed using the incremental cost-effectiveness ratio formula (ICER).
Participants/Inclusion and exclusion criteria
Some important entry criteria: being main caregiver of the patient and a history of at least 3 months of caring the MS patient, A patient suffering from MS for more than six months
Important criteria for non-entry: participation in similar educational programs and having uncorrectable visual and hearing problems
Intervention groups
In intervention group, educational content is shared virtually through Eitta messenger. In control group, the same educational content will be presented through lectures, group discussions. Cost-effectiveness in each group is calculated using the incremental cost-effectiveness ratio formula (ICER).
Main outcome variables
Care burden of caregivers of MS patients using Zarit care burden questionnaire; the Cost-effectiveness of training based on caregivers' burden of care
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231212060344N1
Registration date:2024-02-25, 1402/12/06
Registration timing:prospective
Last update:2024-02-25, 1402/12/06
Update count:0
Registration date
2024-02-25, 1402/12/06
Registrant information
Name
Farzaneh Salehi-Tizabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3189 2105
Email address
salehif992@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-03-05, 1402/12/15
Expected recruitment end date
2024-06-21, 1403/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the cost-effectiveness of face-to-face and virtual healthy lifestyle training on the burden of care in caregivers of multiple sclerosis patients
Public title
cost effectiveness of healthy lifestyle training on the burden of care in caregivers of multiple sclerosis patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
Age 18 y/o and older
Willingness to participate in research
Access to mobile phones with Android operating system
Being literate
At least 3 months of patient care experience
Being the main caregiver of the patient
The stability of the patient's clinical condition
Exclusion criteria:
Having visual and hearing problems
Participate in similar training courses in the last three months
A history of mental disorders
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization. First, based on the inclusion criteria, research samples will be selected from the list of MS clinic clients, and then they will be divided into two intervention and control groups using a random number table.
Blinding (investigator's opinion)
Triple blinded
Blinding description
Due to the fact that the data is entered in a coded form in the statistical analysis software, the analyst is unaware of the data of the groups under study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of School of Nursing and Midwifery Mashhad University of Medical Sciences
Street address
Faculty of Nursing and Midwifery, Shahid Kharazmi Building, Azadi Square, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2024-02-06, 1402/11/17
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.117
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35- Multi
ICD-10 code description
https://icd.who.int/browse10/2010/en#/G35
Primary outcomes
1
Description
burden Care of caregivers of multiple sclerosis patients
Timepoint
4 weeks after the end of 5 training sessions
Method of measurement
Zarit care burden questionnaire
2
Description
The cost-effectiveness of education in two ways, face-to-face or virtual
Timepoint
4 weeks after the end of 5 training sessions
Method of measurement
Incremental Cost Effectiveness Ratio Formula
Secondary outcomes
empty
Intervention groups
1
Description
In intervention group, the educational content is taught virtually through the Eitta messenger during 5 weeks in 5 sessions (45-60 minutes).
Category
Lifestyle
2
Description
In control group, the same educational content will be presented through lectures, group discussions in face-to-face sessions during 5 weeks in 5 sessions (45-60 minutes).
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem Hospital affiliated to Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Bakhshi
Street address
Faculty of Nursing and Midwifery, Shahid Kharazmi Building, Azadi Square, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 912 618 4054
Email
bakhshim@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Mohsen Tafaghghodi - Vice President of Research and Technology
Street address
Research and Technology Vice-Chancellor, University Street, Central Building of Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@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
Mahmoud Bakhshi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shahid Kharazmi Building, Azadi Square, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
bakhshim@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Bakhshi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shahid Kharazmi Building, Azadi Square, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
bakhshim@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mahmoud Bakhshi
Position
faculty member
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing and Midwifery, Shahid Kharazmi Building, Azadi Square, Mashhad University of Medical Sciences, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Phone
+98 51 3859 1511
Email
bakhshim@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
To maintain data confidentiality
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
The results of the research will be published in the text of the thesis and also through the article.
When the data will become available and for how long
After the completion of the study and defense of the thesis, about the next 7 to 8 months
To whom data/document is available
all people
Under which criteria data/document could be used
without any preconditions
From where data/document is obtainable
Website of Central Library of Mashhad University of Medical Sciences
What processes are involved for a request to access data/document