Determine the cost-effectiveness of a motor exercise program based on augmented reality pamphlet on fatigue in hemodialysis patients
Design
A randomized parallel-group trial with blinded outcome assessment. Patients were randomly divided into intervention and control groups based on the day of referral for hemodialysis.
Settings and conduct
The present study will be conducted in the dialysis centers of Montaserihe and 17 Shahrivar Hospitals in Mashhad. For the intervention group, the training program based on the augmented reality pamphlet will be implemented in addition to the routine of the dialysis department for 6 weeks. The study participants will complete the MFI-20 fatigue questionnaire before, one week, and 6 weeks after the intervention. Costs are considered from the service provider's perspective. The cost-effectiveness in each group is determined using the incremental cost-effectiveness ratio formula. The cost in this formula is the average cost in Rials and the effectiveness is the mean change in patients' fatigue at the end of the intervention.
Participants/Inclusion and exclusion criteria
Entry conditions: having access to mobile phones with the Android operating system, age 18 to 64 years, Doing 3 dialysis sessions a week
Non-entry conditions: having visual and hearing problems, having instability in clinical condition
Intervention groups
For the intervention group, the training program based on the Augmented Reality pamphlet will be implemented for 6 weeks (every other day), which includes a series of stretching and muscle-strengthening movements. By placing their phone and scanning the barcode on the pamphlet, patients can watch the content and movement exercises in the form of video and perform them as they will be taught.
Main outcome variables
Fatigue score using the MFI questionnaire and the cost-effectiveness of education based on fatigue parameter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230724058913N1
Registration date:2023-08-12, 1402/05/21
Registration timing:prospective
Last update:2023-08-12, 1402/05/21
Update count:0
Registration date
2023-08-12, 1402/05/21
Registrant information
Name
robabeh molaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3658 8908
Email address
molaeir4001@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2024-03-19, 1402/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The cost effectiveness of motor exercise program based on augmented reality pamphlet on the fatigue in hemodialysis patients
Public title
Investigating the effect and cost of performing body movement exercises using augmented reality technology on the fatigue of dialysis patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the research
Being alert
Having access to a mobile phone with the Android operating system
The ability of the patient or his companion to use a mobile phone and related software.
The absence of mental disorders
Not having visual and hearing problems
Being literate
Not receiving Previous training in mobility aids or failure to implement the patient's rehabilitation program in the last three months.
Age 18 to 60 years
History of at least 8 months of hemodialysis
Stable condition of the patient from a clinical point of view
Able to walk without assistance.
No history of acute illness in the last one month
Visiting and doing 3 dialysis sessions a week
Living with family
Exclusion criteria:
Age
From 18 years old to 64 years old
Gender
Both
Phase
3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is done using lottery based on the day of patients' visits, because patients come every other day for dialysis and the interaction of two groups should be prevented. In such a way that the patients referred for dialysis on even or odd days will be placed in the test or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Blinding for the analyst
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mashhad University of Medical Sciences
Street address
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah Street, Mashhad. Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913199
Approval date
2023-07-25, 1402/05/03
Ethics committee reference number
IR.MUMS.NURSE.REC.1402.066
Health conditions studied
1
Description of health condition studied
Chronic kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Fatigue score of hemodialysis patients using the MFI fatigue questionnaire
Timepoint
Measuring fatigue before the intervention, 1 and 6 weeks after the intervention
Method of measurement
MFI fatigue measurement questionnaire
Secondary outcomes
1
Description
The cost-effectiveness of motor exercise program based on augmented reality pamphlet
Timepoint
At the end of the 6-week intervention
Method of measurement
Using the incremental cost-effectiveness ratio formula
Intervention groups
1
Description
For the intervention group, the training program based on the Augmented Reality pamphlet will be implemented for 6 weeks (every other day), which includes a series of stretching and muscle-strengthening movements. By placing their phone and scanning the barcode on the pamphlet, patients can watch the content and movement exercises in the form of video and perform them as they will be taught.
Deputy research assistant, Qureshi building, Daneshgah Street, Mashhad, Iran
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
vcresraech@mums.ac.ir
Web page address
https://v-research.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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah Street, 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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah Street, 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
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Doctora Crossroad, Daneshgah Street, 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)
Yes - There is a plan to make this available
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
After coding and making the data unidentifiable, they are analyzed and published in the form of a thesis and an article.
When the data will become available and for how long
After the end of the intervention and the analysis of the results, the thesis chapters and the resulting article are written and published.
To whom data/document is available
All the people
Under which criteria data/document could be used
Non-identifiable data can be used by all researchers and reviewers of the journal publishing the results.
From where data/document is obtainable
To the main executive of the project or the responsible author of the article or the library of the Faculty of Nursing and Midwifery of Mashhad University of Medical Sciences
What processes are involved for a request to access data/document
E-mail to the main executive of the project or the author responsible for the article
E-Mail: Bakhshim@mums.ac.ir