Design and create a mobile-based self-care program as a new care plan for people with MS.
Design
Clinical trials with control group, with parallel groups, blinded, randomised
Settings and conduct
This study will be conducted in 1398 at the Center for MS Society of Chaharmahal and Bakhtiari province.
Participants/Inclusion and exclusion criteria
Having a smart phone and writing literacy, having no underlying problem
Intervention groups
After assigning individuals to intervention and control groups, the status of daily activities of life, balance and walking and tremor are measured in both groups. The intervention group will receive a mobile-based self-care program, and only routine care will be provided for the control group. After the end of 2 months of interventions (training and application of mobile applications), the status of everyday life, balance, walking and tremor in both groups is reassessed. To evaluate the efficacy of the interventions, the mean score of each variable before and after intervention in both groups as well as the mean of variables before and after the intervention will be compared between the two groups
Main outcome variables
Reducing and controlling symptoms, getting acquainted with the disease, improving lifestyle
General information
Reason for update
Acronym
MSP
IRCT registration information
IRCT registration number:IRCT20190318043087N1
Registration date:2019-04-29, 1398/02/09
Registration timing:prospective
Last update:2019-04-29, 1398/02/09
Update count:0
Registration date
2019-04-29, 1398/02/09
Registrant information
Name
Shirmohammad Davodvand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 38 3225 1988
Email address
sh.davodvand@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-30, 1398/02/10
Expected recruitment end date
2019-05-05, 1398/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of mobile-based self-care program on motor disorders and activity daily living of people with Multiple Sclerosis
Public title
The effect of mobile-based self-care program on motor disorders and activity daily living of people with MS
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis by neurologist
Age range from 20 to 50 years
Not having a history of underlying diseases such as orthopedic and cardiovascular diseases according to medical records of the patient
Not having severe mental disorders such as major depression
Have a smartphone
EDSS scores between zero and 4 if they get score from 0 to 4
The desire to participate in the study
Ability to read and write in Persian language
Ability to use smart phone
Exclusion criteria:
Unwillingness to continue participating in the study
Creating complications that cause the patient to not be able to continue studying
Failure to fill out self-reporting checklist at least 80% of the days of the study
Age
From 20 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Sample entry will be done by easy sampling method and then the distribution of samples in the test and control group is randomly assigned to the block
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, both the primary and secondary evaluators as well as those who analyze the data are unaware of the test and control groups.
Placebo
Not used
Assignment
Parallel
Other design features
In this study, a self-care program with MS-related content, symptom management, daily life with MS, nutrition, motor vehicle accessories, exercise movements, corrective movements and appropriate tensile movements on the wheelchair installation patients smart phones.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahrekord University of Medical Sciences
Street address
Kashani Blvd, Shahrekord University of Medical Sciences
City
Shahrekord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Approval date
2019-02-27, 1397/12/08
Ethics committee reference number
IR.SKUMS.REC.1397.290
Health conditions studied
1
Description of health condition studied
Multiple Sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system
Primary outcomes
1
Description
Motordisorders
Timepoint
At the beginning of the study and two months later
At the beginning of the study and two months later
Method of measurement
Barthel Index of Activities of Daily Living
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-care program is installed on the patient's mobile phone and patients should follow this program for 2 months. Before and after the study, the completed questionnaires will be completed for patients.
Category
Prevention
2
Description
Control group: This group will not receive any interventions during the study period and they will complete the questionnaires only before and 2 months after the start of the study.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
MS association
Full name of responsible person
Abbas Safian
Street address
Navab Safavi Street
City
Broujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8876135698
Phone
+98 38 3423 9960
Email
abbas.safian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Dr Kamal Solati
Street address
Kashani Blvd
City
ShahreKord
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8815713471
Phone
+98 38 3333 0061
Email
kamal_solati@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahre-kord 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
Shahre-kord University of Medical Sciences
Full name of responsible person
Abbas Safian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Barati street
City
Boldaji
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8876133337
Phone
+98 38 3464 0091
Email
abbas.safian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Abbas Safian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Barati street
City
Boldaji
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8876133337
Phone
+98 38 3464 0091
Email
abbas.safian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahre-kord University of Medical Sciences
Full name of responsible person
Abbas Safian
Position
Masters student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Shahid Barati street
City
Boldaji
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8876133337
Phone
+98 38 3464 0091
Email
abbas.safian@yahoo.com
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
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available