Determining the effect of self-care education with telemedicine approach on health-promoting behaviors in MS patients, members of MS Jahrom Association in 1999
Design
A clinical trial with a control group, with a single group, randomized on 70 patients. For randomization, simple random sampling method was used.
Settings and conduct
Trainings will be conducted according to the dimensions of the Walker questionnaire including (nutrition, exercise, health responsibility, stress management, interpersonal support, self-fulfillment). Sending content in multimedia format through WhatsApp software in groups), Mondays (telephone training that the researcher establishes with patients between 8 am and 8 pm), Wednesdays (evaluation of patients by telephone by the researcher) Intervention Will do the training.
Participants/Inclusion and exclusion criteria
Entry requirements:
The patient has informed consent to participate in the study.
Have a definite diagnosis of MS by a neurologist.
Patients should be between 18 and 40 years old.
Have enough ability for self-care.
Mobile access and how to use the WhatsApp application.
Exit conditions:
The patient is not able to implement a self-care program due to the complications of the disease.
Lack of access to mobile phones
Failure to follow the training program
Intervention groups
The educational intervention is in the form of distance learning which is done for the intervention group during the intervention and for the control group after the end of the intervention to observe ethics.
Main outcome variables
If the method of self-care education is effective, it can be used to improve the health of patients with MS and increase the independence and self-confidence of patients in self-care.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20201112049367N1
Registration date:2021-03-27, 1400/01/07
Registration timing:retrospective
Last update:2021-03-27, 1400/01/07
Update count:0
Registration date
2021-03-27, 1400/01/07
Registrant information
Name
yasaman pourfarid
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5433 6006
Email address
yasaman.pourfarid@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-03, 1399/12/13
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of self-care education with telenursing approach on health-promoting behaviors in MS patients
Public title
the effect of self-care education on health-promoting behaviors
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
The patient has informed consent to participate in the study.
Have a definite diagnosis of MS by a neurologist.
Patients are between 18 and 40 years old.
Be literate and media literate.
They are not in the acute stage of the disease and at least 6 weeks have passed since the last recurrence of the disease.
Have enough ability to take care of themselves.
At least 2 years have passed since the first diagnosis.
Mobile access and how to use the WhatsApp application.
Exclusion criteria:
The patient withdraws from the study for any reason.
The patient is not able to implement a self-care program due to the complications of the disease.
Acute and critical attacks of the disease during the intervention.
Have other acute illnesses such as heart, kidney, respiratory, gastrointestinal and metabolic diseases other than MS.
Lack of access to mobile phones
Absence of more than two sessions in training sessions
Failure to follow the training program
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling will be random. Based on the announcement of patients' readiness to participate in the study, each patient is given a number. These numbers will be randomly divided into two groups of 35 (intervention and control) using software. Sampling is done by simple random method of lottery. That is, the names of the people are written on a card and placed inside the box, then the cards are taken out one by one until the desired sample size is completed.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه علوم پزشکی جهرم
Street address
Andisheh Street, Alley 3
City
Jahrom
Province
Fars
Postal code
7417765485
Approval date
2021-03-03, 1399/12/13
Ethics committee reference number
IR.JUMS.REC.1399.142
Health conditions studied
1
Description of health condition studied
MS patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
health-promoting behaviors
Timepoint
Immediately before and after the intervention
Method of measurement
Health Promoting Lifestyle Questionnaire Walker et al
Secondary outcomes
1
Description
Distance nursing self-care training
Timepoint
6 week
Method of measurement
Health Promoting Lifestyle Questionnaire Walker et al
Intervention groups
1
Description
Intervention group: MS patients
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
انجمن ام اس شهرستان جهرم
Full name of responsible person
kambiz sohrabi jahromi
Street address
Shahid Bahonar Blvd. Alley 18
City
Jahrom
Province
Fars
Postal code
7416613448
Phone
+98 71 5433 6073
Email
sohrabi_kambiz@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
kavoos solhjoo
Street address
Ostad motahari Blvd
City
Jahrom
Province
Fars
Postal code
۴۶۱۹۹-۷۴۱۴۸
Phone
+98 71 5434 0405
Email
jums@jums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Jahrom 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
Jahrom University of Medical Sciences
Full name of responsible person
ali dehghani
Position
Director of Graduate Studies
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Motahhari St. - School of Nursing and Paramedical
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5433 1501
Email
Ali.Dehghani۲۰۰۰@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
ali dehghani
Position
Director of Graduate Studies
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Motahhari St. - School of Nursing and Paramedical
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5433 1501
Email
Ali.Dehghani۲۰۰۰@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
ali dehghani
Position
Director of Graduate Studies
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Motahhari St. - School of Nursing and Paramedical
City
Jahrom
Province
Fars
Postal code
74148-46199
Phone
+98 71 5433 1501
Email
Ali.Dehghani۲۰۰۰@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
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
All data is potentially shareable after unidentified individuals
When the data will become available and for how long
Access period starts from 1400
To whom data/document is available
It will be available to researchers working in academia.
Under which criteria data/document could be used
In secondary studies, data will be available to researchers
From where data/document is obtainable
Contact Ali.Dehghani2000@gmail.com with this email
What processes are involved for a request to access data/document