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Effect of peer education method on life expectancy and quality of life in patients with multiple sclerosis: a before-after clinical trial

Protocol summary

Study aim
To assess the effect of peer education method on life expectancy and quality of life in patients with multiple sclerosis
Design
This is a before-after clinical trial, in which 40 eligible patients will be assigned to the intervention group.
Settings and conduct
The eligible patients with multiple sclerosis referring to the Sina Hospital in Hamadan city during the study period will be enrolled in the trial.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age of 18 to 65 years, Affected with multiple sclerosis, Exclusion criteria: The duration of the disease is less than 5 years
Intervention groups
Intervention group: Face-to-face training through peer education method for 60 minutes once a week for 2 weeks
Main outcome variables
Primary outcome: Life expectancy, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120215009014N346
Registration date: 2020-03-13, 1398/12/23
Registration timing: prospective

Last update: 2020-03-13, 1398/12/23
Update count: 0
Registration date
2020-03-13, 1398/12/23
Registrant information
Name
Jalal Poorolajal
Name of organization / entity
Department of Epidemiology & Biostatistics Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1838 0090
Email address
poorolajal@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-20, 1399/02/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peer education method on life expectancy and quality of life in patients with multiple sclerosis: a before-after clinical trial
Public title
Effect of peer education method on life expectancy and quality of life in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 to 65 years, Affected with multiple sclerosis,
Exclusion criteria:
The duration of the disease is less than 5 years
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
N/A
Randomization description
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
Ethics Committee of Hamadan University of Medical Sciences
Street address
Vice-chancellor for Research and Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.UMSHA.REC.1398.1059

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
Life expectancy
Timepoint
Before the intervention and one month after that
Method of measurement
Using Miller Health Scale (MHS) questionnaire

2

Description
Quality of life
Timepoint
Before the intervention and one month after that
Method of measurement
Using Ware & Sherbourne questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Face-to-face training through peer education method for 60 minutes once a week for 2 weeks
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital in Hamadan city
Full name of responsible person
Mohadese Jamehbozorg
Street address
Sina Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3827 4184
Email
mohadesejamehbozorg@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0717
Email
info.research@umsha.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Mohadese Jamehbozorg
Position
Student of Nursery
Latest degree
Master
Other areas of specialty/work
Nuclear Medicine
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mohadesejamehbozorg@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Morteza Shamsizadeh
Position
Master of Nursery
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0572
Email
mortezashamsizadeh@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr. Jalal Poorolajal
Position
Professor of Epidemiology
Latest degree
Ph.D.
Other areas of specialty/work
Epidemiology
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3838 0090
Email
poorolajal@umsha.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
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