Determining the effect of web-based self-care intervention on the lifestyle of patients with multiple sclerosis
Design
Clinical trial with control group, single blind, randomized, 40 patients in each group
Settings and conduct
First, with the self-care needs assessment questionnaire, the self-care status will be measured in both test and control groups during a two-week period . In this research, there is a program in the form of the ORM conceptual model and based on the educational needs of the multiple sclerosis patients participating in the program, which will be obtained by completing the ORM needs assessment form, and based on the results obtained from the needs assessment, educational content will be designed. For this purpose, a web page will be created and the intervention group will be taught how to work with the defined web page. After the training course and the end of the intervention, the lifestyle questionnaire will be given to both test and control groups again and data will be collected.
Participants/Inclusion and exclusion criteria
• Diagnosis of multiple sclerosis by a neurologist
• Not having medical education and not being in medical and paramedical groups
• Ability to perform self-care activities
• Access to a smart phone or personal computer
Intervention groups
The samples will be distributed to the test and control groups and the content of the intervention will be presented to the test group through the web. In this educational method, text, images and videos will be used to increase access and depth of learning. Self-care assessment is done using questionnaires before and after the intervention. The control group will not receive any intervention by the research team. They will have routine interventions provided by the center.
Main outcome variables
lifestyle of patients with multiple sclerosis
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20240811062717N1
Registration date:2024-11-24, 1403/09/04
Registration timing:retrospective
Last update:2024-11-24, 1403/09/04
Update count:0
Registration date
2024-11-24, 1403/09/04
Registrant information
Name
Sara Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3373 3642
Email address
sara.akbari9677@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-08-22, 1403/06/01
Expected recruitment end date
2024-11-21, 1403/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Web-based Self-care Program on the Lifestyle of Patients with Multiple Sclerosis
Public title
The Effect of Web-based Self-care Program on the Lifestyle of Patients with Multiple Sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of Multiple Sclerosis by a Neurologist
Willingness to Participate in the Study
Being Literate and Older than 18 Years
At Least Six Months Have Passed since the Diagnosis of the Disease
Not Having Medical Education and not Being in Medical and Paramedical Groups
Ability to Perform Self-care Activities
Access to a Smart Phone or Personal Computer
Exclusion criteria:
Participation in other educational interventions at the same time as the present study
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
The participants of the study will be selected from among all the people of the research community using the available method and then will be divided into two groups, group A (examination or web-based virtual training group) and group B (control) in the form of random allocation by block method.
Since we will have two groups in this study, it is planned to have blocks of four. For example; Block number one may be AABB, which means that the first and second eligible patients are assigned to the intervention group (web-based virtual education). All the possible shapes of the blocks that were determined will be placed in separate envelopes. Envelopes will be randomly numbered for opening order. The random selection of numbers for the envelopes will be done by the project manager and the order of grouping of the patients will be announced to the student.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analyst: The people who analyze the data collected during the study do not know which study group the data belongs to.
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zanjan University of Medical Sciences
Street address
15, Mehrabad Ave., Hafez Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Approval date
2024-08-20, 1403/05/30
Ethics committee reference number
IR.ZUMS.REC.1403.151
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
Primary outcomes
1
Description
The lifestyle score in the Walker questionnaire, scores above 150, the lifestyle of the patients is very good
Timepoint
Completing the Walker questionnaire before and after the intervention by both groups of participants
Method of measurement
Walker's lifestyle questionnaire, which has 54 questions in six dimensions (nutrition, exercise, responsibility for health, stress management, interpersonal support, self-actualization) and its purpose is to measure health-promoting behaviors. Its response range is of Likert type (never 1, some 2, often 3, always 4). Its scores range from 54 to 216. If the scores of the questionnaire are between 54 and 62, the lifestyle is poor, between 62 and 150, the average level, scores above 150, the lifestyle of the patients is very good.
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The training course will be held in the form of a one-month workshop, and four days a week and Each session averages 30 minutes in the web space for the intervention group. For this purpose, a web page will be created and the intervention group will be taught how to work with the defined web page. The offline training workshop will include familiarization with Multiple Sclerosis, symptom management, possible complications, nutrition, disease control methods and prevention of complications caused by Multiple Sclerosis, which will be provided to patients in simple language along with pictures, videos and messages.
Category
Lifestyle
2
Description
Control group: The control group will not receive any intervention by the research team. They will have routine interventions provided by the center. Routine interventions include outpatient visits to the clinic to receive medication and, if necessary, visits by the treating physician.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
MS Clinic of Waliasr Hospital, Zanjan
Full name of responsible person
Sara Akbari
Street address
15, Mehrabad Ave, Hafez Blvd
City
urmia
Province
West Azarbaijan
Postal code
5714615463
Phone
+98 44 3373 3642
Email
sara.akbari9677@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Korosh Amini
Street address
15, Mehrabad Ave, Hafez Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Phone
+98 44 3373 3642
Email
sara.akbari9677@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Sara Akbari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15، 1 Ave.، Mehrabad.، Hafez Blvd.، Urmia and Chonghralou pol
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Phone
+98 44 3373 3642
Fax
Email
sara.akbari9677@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sara Akbari
Position
student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15, Mehrabad Ave., Hafez Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Phone
+98 44 3373 3642
Email
sara.akbari9677@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Sara Akbari
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
15, Mehrabad Ave., Hafez Blvd
City
Urmia
Province
West Azarbaijan
Postal code
5714615463
Phone
+98 44 3373 3642
Email
sara.akbari9677@gmail.com
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
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals.
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Researchers working in academic and scientific institutions
From where data/document is obtainable
Sara Akbari
tel: 0098 09144867303
email: sara.akbari9677@gmail.com
What processes are involved for a request to access data/document