Effect of self-care program based on mobile learning and face to face education methods on quality of life and coping skills in patients with multiple sclerosis
Determining and comparing the average score of quality of life and coping skills in research units before and after the intervention
Comparison of changes and determination of the effectiveness of intervention in two educational groups
Design
Clinical trials with two parallel training groups and random block allocation are performed using Randomization software, and finally seven four-person blocks are created by this software.
Settings and conduct
56 patients with multiple sclerosis who are referred to Kashani Hospital will be selected by easy sampling method and will be randomly divided into two groups based on mobile education and face training. Then, the questionnaire will be completed by the research units to measure the quality of life and coping skills, and then face-to-face and mobile-based training sessions will be held in the relevant training groups. After completing the training and giving patients a four-week opportunity to perform and practice self-care activities while following them by phone calls during this period, the questionnaires will be completed by two groups.
Participants/Inclusion and exclusion criteria
Entry requirements: Diagnosis should be made by a specialist and they should be willing to participate in the research.
Conditions for non-entry: relapse or participation in another training program
Intervention groups
A self-care program for patients with multiple sclerosis will be taught face-to-face with the group. In the mobile-based educational group, the same educational content will be installed on patients' mobile phones or tablets in the form of software.
Main outcome variables
The main variables of this study include quality of life and coping skills.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190712044181N5
Registration date:2020-06-17, 1399/03/28
Registration timing:prospective
Last update:2020-06-17, 1399/03/28
Update count:0
Registration date
2020-06-17, 1399/03/28
Registrant information
Name
shahla Abolhassani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7548
Email address
abolhasani@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self-care program based on mobile learning and face to face education methods on quality of life and coping skills in patients with multiple sclerosis
Public title
The effect of self-care program on quality of life and coping skills of multiple sclerosis patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
At least six months have passed since the diagnosis
The definitive diagnosis of multiple sclerosis is confirmed by a neurologist and the patient has a medical record.
Have a desire to participate in the study
Ability to work with mobile and the ability to install software on the patient's mobile
Be able to understand the questions of the questionnaire
Exclusion criteria:
Having hearing and vision problems
The participants will have other training programs at the same time
Patients who are in the process of relapse
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
56
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, the samples will be selected by easy sampling method from patients with multiple sclerosis referred to Ayatollah Kashani Hospital who have the criteria to enter the research.Based on this, the samples will be introduced to the research team at the time of referral, and if they agree to participate in the study, they will be placed in the intervention or control groups based on the randomization framework. Random allocation of individuals in the two groups of e-learning and face-to-face training is based on randomized block allocation. Thus, 56 samples are divided into seven blocks of eight.The size of the blocks is equal to 8 people (4 people in each group). In each block, the members of the intervention and control group are identified by the letters A and B. For those who accept, assigning groups A and B to e-learning and face-to-face training will be unclear. Random allocation by block method is done using Random Allocation Software.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-01-27, 1398/11/07
Ethics committee reference number
IR.MUI.RESEARCH.REC.1399.062
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
Quality of life score in standard questionnaire of quality of life in patients with multiple sclerosis(multiple sclerosis impact scale)
Timepoint
Measurement of quality of life before the intervention and one month after the intervention
Method of measurement
Quality of Life Questionnaire in Multiple Sclerosis Patients
2
Description
coping Skills Score in the coping with multiple sclerosis questionnaire
Timepoint
Measure coping skills before the intervention and one month after the intervention
Method of measurement
coping with multiple sclerosis questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Face-to-face training group.The educational content of the self-care program is provided based on the needs assessment of patients and will be presented in the face-to-face training group individually or in groups of two or three people in four sessions with one week intervals that each session will last 30-45 minutes.
Category
Other
2
Description
Intervention group 2: mobile-based training group. Self-care training content similar to face-to-face training group will be installed in the form of software that can be installed on both iOS and Android operating systems on patients' mobile phones or tablets. Simultaneously with the face-to-face training course for four weeks, the mobile-based training course will run for the same period.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Kashani Medical Educational Center
Full name of responsible person
Iman Adibi
Street address
Ayatollah Kashani Ave.Kashani Hospital
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3233 0091
Fax
Email
Kashani@mui.ac.ir
Web page address
https://kashani.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
research@mui.ac.ir
Web page address
https://research.mui.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Shahla Abolhassani
Position
Assistant Professor of Nursing Educational
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7500
Email
abolhassani@nm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla Abolhassani
Position
Assistant Professor of Nursing Educational
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7500
Email
abolhassani@nm.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahla Abolhassani
Position
Assistant Professor of Nursing Educational
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Isfahan University of Medical Sciences, Hezar Jereb Street
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7500
Email
abolhassani@nm.mui.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
Undecided - It is not yet known if there will be a plan to make this available