The aim of this study will be to determine the effect of patient-centered empowerment program through tele-nursing on self-management of patients with Multiple Sclerosis.
Design
Clinical trial with control group, with parallel groups, double-blind, randomized. we will use the block random allocation method for randomization, which requires 23 blocks of 4.
Settings and conduct
This study will be performed at the Iran MS Society in Tehran. Patients will be divided into intervention and control groups by block randomization method (23 blocks of 4). In order to be blind, a dark envelope will be prepared according to the sample size and the envelopes will be numbered according to the sample size. Random sequences will be recorded on a card and placed inside the envelope. At the time of registration, one of the envelopes will be opened in order based on the order of sample entry and the sample group will be specified.
Participants/Inclusion and exclusion criteria
Definitive diagnosis of MS for at least 6 months,
Age range 18 to 60 years,
Ability to use phone and smartphone,
No other physical or mental illness, and
Lack of cognitive and psychological disorders (self-expression and patient record); Reluctance to participate in research
Intervention groups
The intervention group will receive a patient-centered empowerment program to improve self-management in 5 main training sessions over 5 weeks. Patient-centered counseling sessions will be tailored to each patient's needs within 2 weeks. After 8 weeks from the end of the intervention, post-test will be performed and the level of self-management will be analyzed and evaluated using the Multiple Sclerosis Self-Management Scale–Revised.
The control group will receive routine care at the Iran MS Society and at the end of the intervention, educational content will be provided to them.
Main outcome variables
Level of self-management
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210824052281N1
Registration date:2021-09-13, 1400/06/22
Registration timing:prospective
Last update:2021-09-13, 1400/06/22
Update count:0
Registration date
2021-09-13, 1400/06/22
Registrant information
Name
Fateme Bayat
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8822 3165
Email address
f-bayat@razi.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-09-24, 1400/07/02
Expected recruitment end date
2022-01-07, 1400/10/17
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of patient-centered empowerment program through tele-nursing on self-management of patients with Multiple sclerosis
Public title
The effect of empowerment program on self-management of patients with Multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of MS for at least 6 months
Age range 18 to 60 years
Use of phone and smartphone
Exclusion criteria:
Reluctance to participate in research
Other physical or mental illness
Cognitive or psychological disorders (self-expression and patient record)
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
The allocation of samples to the two groups will be by block random allocation method and will be divided into two groups of intervention and control. Due to the sample size, 23 blocks of 4 are required for random block allocation. The intervention group will be displayed by A and the control group with B. Blocks of size 4 can have six modes 1AABB 2-ABAB 3-ABBA 4-BBAA
5BABA 6-BAAB. Then, we roll the dice, for example, 4 comes, it becomes BBAA. We roll the dice again, and for instance, 5 comes BABA, and ... we repeat and roll the dice until all the samples are allocated. In order to re-hide the random specification from the researcher, we will have a dark envelope with the sample size and number the envelopes as the sample size, in such a way that envelope number one is 1 and so on. Each random sequence created will be recorded on a card, placed inside the envelope, and finally pasted into the envelopes. At the time of enrollment in the study, according to the order of arrival of the samples, one of the envelopes will be opened in order and the group of the sample will be determined.
Blinding (investigator's opinion)
Double blinded
Blinding description
On the one hand, there is blindness to the research community that these people will not find out that they are in the experimental group or in the control group. The allocation for these individuals will be random and they will not be told that they are in the test or control group. The other side that will be blind is the person who will perform the statistical analysis and will not find out whether the data obtained belong to the experimental group or the control group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the School of Nursing and Midwifery and the School of Rehabilitation, Tehran Uni
Street address
North Kargar St., 16th St., Alley Complex, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1439957181
Approval date
2021-07-26, 1400/05/04
Ethics committee reference number
IR.TUMS.FNM.REC.1400.083
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
Self-management score on The Multiple Sclerosis Self-Management Scale–Revised
Timepoint
At the beginning of the study (before the start of the intervention) and after 8 weeks from the end of the intervention
Method of measurement
The Multiple Sclerosis Self-Management Scale–Revised
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the intervention group, individuals in 5 main training sessions over 5 weeks will recieve empowerment program designed in physical dimensions that include: nutrition and diet, sleep, physical activity and exercise, fatigue management, movement problems, pain, body temperature control, vaccination, unhealthy habits (alcohol consumption, smoking) and women's health (menstrual cycle, menopause) in the first and second sessions, topics related to psychological dimensions that include: stress and anxiety management, mood control and management, problem solving skills, promoting resilience and life satisfaction in the third and fourth sessions and finally the topics related to social dimensions that include: employment, participation in society and social performance, lifestyle at home, free time, friendship and relationship, identification of family needs (role structure, responsibilities, goals, etc.) in the fifth session. After these main training sessions, counseling sessions will be held for two weeks according to the needs of each patient. The number of these sessions will vary according to the conditions and needs of each patient. After 8 weeks from the end of the intervention, post-test will be performed and finally the data before and after the intervention will be analyzed and evaluated using the Multiple Sclerosis Self-Management Scale–Revised.
Category
Rehabilitation
2
Description
Control group: Control group: The control group will receive the routine care of the Iran MS Society and at the end of the intervention, educational content will be provided to them.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran MS Society
Full name of responsible person
Seyed Khosrow Sadegh Mousavi
Street address
No. 35, Shahid Mohammad Shams Alley, Tesghani Intersection, Vesal Shirazi St., Enghelab St.
City
Tehran
Province
Tehran
Postal code
1993753873
Phone
+98 21 6695 3907
Fax
+98 21 6649 9514
Email
info@iranms.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Sahraeian
Street address
No. 8, Unit 5, Alley 7.35, Simetri Niroohavayi St, Damavand St.
City
Tehran
Province
Tehran
Postal code
1748953637
Phone
+98 21 6142 6670
Email
msahrai@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Fateme Bayat
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (Nosrat Sharghi), School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
f-bayat@razi.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Bayat
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (Nosrat Sharghi), School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
f-bayat@razi.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Fateme Bayat
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Tohid Square, Dr. Mirkhani St. (Nosrat Sharghi), School of Nursing and Midwifery, Tehran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6692 7171
Fax
Email
f-bayat@razi.tums.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
Considering that the present study is an academic dissertation and a copy of it is provided to Tehran University of Medical Sciences; Therefore, all data can be shared after being unidentified.
When the data will become available and for how long
Access to the documentation of this study begins three months after the results are published.
To whom data/document is available
Data and documentation of this study will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
All researchers working in scientific and academic centers, including researchers in multiple sclerosis centers, professors, students of nursing, all medical and paramedical degrees, nurses working in hospitals and community health centers, doctors, educational and research officials of multiple sclerosis centers and individuals workers in other paramedical disciplines are allowed to request unidentified data from this study. The use of the documents of this study can be used for all the mentioned groups only by mentioning the source and without any interference in its texts.
From where data/document is obtainable
Considering that a copy of the dissertation will be provided to the library of the School of Nursing and Midwifery of Tehran University of Medical Sciences; Therefore, clients can visit the library of this center in person at: Tohid Square, Dr. Mirkhani St. (Eastern Nusrat), School of Nursing and Midwifery, Tehran University of Medical Sciences; Phone number: +982166927171; Or visit the library site of Tehran University of Medical Sciences in absentia at http://lib.tums.ac.ir/ to benefit from the documents of this study.
What processes are involved for a request to access data/document
If you visit the library of the School of Nursing and Midwifery of Tehran University of Medical Sciences in person, the client can read the research documents in the library by introducing himself to the librarian and presenting a valid ID card. It should be noted that the client will not be allowed to take the document out of the library and take a photo of it. If you visit the library site of Tehran University of Medical Sciences in absentia, the client will enter a part of the study title in the search box and a summary of the present study will be displayed for him.