The Comparison of the Effect of Self-Care Education Based on Team Members Teaching Design and lecture on Quality of Life and Self-efficacy in Patients with Multiple Sclerosis
The purpose of this study was to determine and compare the effect of self-care education based on
Team Members Teaching Design and lecture on quality of life and self-efficacy in patients with multiple sclerosis.
Design
This is an experimental intervention study, without blinding with two intervention groups and one control group. The sample size is 60 patients and the samples are randomly selected and then randomly assigned into three groups of 20 each.
Settings and conduct
This study is performed on patients with multiple sclerosis referred to MS Association of Jahrom city in the year 2019. The study population included all patients with multiple sclerosis referred to MS Association of Jahrom city.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged between 18-60 years and literate, at least two years past first diagnosis, not in acute phase of illness and at least 6 weeks past last recurrence and ability Take care of yourself. Exclusion criteria: The patient withdrew from the study for any reason and missed more than two sessions during the intervention or was unable to carry out the self-care program due to complications.
Intervention groups
Interventions consisted of six sessions of lecture in the first group and six sessions of teaching in the second group according to the patients' educational needs and no intervention in the control group. Quality of life and self-efficacy before and immediately after the intervention and 30 days after the intervention by the questionnaire will be reviewed.
Main outcome variables
Improving quality of life and self-efficacy in MS patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190127042506N1
Registration date:2020-01-08, 1398/10/18
Registration timing:retrospective
Last update:2020-01-08, 1398/10/18
Update count:0
Registration date
2020-01-08, 1398/10/18
Registrant information
Name
fariba fakhravari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5444 7373
Email address
f.fakhravari@jums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-20, 1397/12/01
Expected recruitment end date
2019-03-01, 1397/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effect of Self-Care Education Based on Team Members Teaching Design and lecture on Quality of Life and Self-efficacy in Patients with Multiple Sclerosis
Public title
The Comparison of the Effect of Self-Care Education Based on Team Members Teaching Design and lecture on Quality of Life and Self-efficacy in Patients with Multiple Sclerosis
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1. The patient is informed to participate in the study of satisfaction.
A definitive diagnosis of MS by a neurologist.
Patients aged 18-60 years.
Have literacy to read and write
Not in the acute phase of the disease and at least 6 weeks after the last relapse of the disease
Have the ability to take care of yourself
At least 2 years after the first diagnosis of the disease.
Exclusion criteria:
Absence of more than 2 sessions during the intervention will exclude them from participating in the study.
Patient for any reason not to continue to participate in the study.
The patient will not be able to implement the self-care program due to the complications of the disease.
During the intervention, there are acute and critical attacks of the disease.
There are other acute illnesses, such as heart disease, kidney, respiratory, digestive and metabolic diseases other than MS.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Using computer and randomly assigned patients in one of the three groups of self-care education based on team members (intervention), self-care education is based on lecture (intervention) and control group. In random assignment, each patient is code-fed through a computer system, randomly, code one in the self-care training group based on team members (intervention), code 2 in the self-care education group based on lecture (intervention), and Code three is in the control group.
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 jahrom university of medical sciences
Street address
Motahari Ave
City
Jahrom
Province
Fars
Postal code
7414846199
Approval date
2019-03-13, 1397/12/22
Ethics committee reference number
IR.JUMS.REC.1397.152
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
Timepoint
Before intervention, immediately after intervention, 30 days after intervention
Method of measurement
Standard questionnaire Multiple sclerosis quality of life: MSQOL-54 -Barbara G. Vickrey (1995) University of California, Los Angeles
2
Description
Self-efficacy
Timepoint
Before intervention, immediately after intervention, 30 days after intervention
Method of measurement
Multiple sclerosis Self-efficacy Scale-Rigby et al. (2003) - England
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Self-Care Education Based on Team Members Teaching Design:The education plan will be held for 4-6 sessions per hour in accordance with the educational needs. The number of sessions may be more or less relevant to educational needs. 1. The patients will be divided into four teams of five people from a few days ago.2. The researcher will prepare a self-care education based on the outcome of the need assessment and share it in equal amounts and will be distributed among all patients one week before and they will be required to read the content in advance to expedite their implementation.3. On the day of the performance, according to the previous division of the members, the first persons of each of the four teams in one category, the second team of each team in a category and the third team of each team in another group, and so on, the fourth and fifth teams of each team Will be in another category. In fact, there will be four groups of five, each with a single item in their main teams.4. Then, patients are asked to discuss, discuss, and understand the contents of all five subjects with the same content in each of the categories for 10 minutes.5. After completing the first stage, all members of the team will return to their main teams and, for 10-15 minutes, they will provide their own materials in their teams, as well as ask questions and answer questions.6. At the end of the summary, the questions will be answered by the researcher.
Category
Lifestyle
2
Description
Intervention group: Effect of Self-Care Education Based on lecture:The education plan will be held for 4-6 sessions per hour in accordance with the educational needs. The number of sessions may be more or less relevant to educational needs.Teaching in the lecture group will include presenting the Content by lecture with questions and answers, summarizing the Contents and answering the questions by the researcher.
Category
Lifestyle
3
Description
Control group: They will not be given to the control group during the study, but in order to comply with the research ethics, after the patients completed the post-intervention questionnaire, for the control group the self-care education program was more efficiently based on the results of the research , Will be done by the researcher.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Multiple Sclerosis Society
Full name of responsible person
Mr Kambiz Sohrabi
Street address
Ayatollah Haghshenad Blvd.
City
Jahrom
Province
Fars
Postal code
74131-54232
Phone
+98 71 5426 0150
Email
MS.Society@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Kavus Solhjo
Street address
Ostsd Motahari Ave
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 0405
Email
jums@jums.ac.ir
Web page address
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
Dr Ali Dehghani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Ostad Motahari Ave
City
Jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 1501
Email
ali.dehghani2000@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Dr Ali Dehghani
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
ostad motahari Ave
City
jahrom
Province
Fars
Postal code
7414846199
Phone
+98 71 5434 1501
Email
ali.dehghani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Jahrom University of Medical Sciences
Full name of responsible person
Fariba Fakhravari
Position
Master student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
No 10. Khayam Ave
City
Jahrom
Province
Fars
Postal code
7413146199
Phone
+98 71 5444 7373
Email
f.fakhravari@jums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD