Objectives: To assess the effect of peer educational program versus no education on self-efficacy in patients with multiple sclerosis.
Design: a randomized clinical trial.
Setting and conduct: The eligible patients with multiple sclerosis who will refer to Farshchian Hospital during the study period will be enrolled into the trial.
Inclusion criteria: age of 18 to 50 years; affected by multiple sclerosis.
Exclusion criteria: participating in the educational programs in the last previous six months; affected by other acute or chronic physical, mental, or psychological disorders; speech or hearing disorders; dependent to wheelchair; acute phase of the disease.
Intervention group: Routine care plus 4 educational sessions for 60 minutes twice a week.
Control group: Just routine care.
Primary outcome: Assessing the patient's self-efficacy before and one month after intervention using Shere questionnaire.
Secondary outcome: Nothing.
Randomization: The patients will be randomly assigned to intervention and control groups by drawing lot.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201608229014N112
Registration date:2016-08-23, 1395/06/02
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-08-23, 1395/06/02
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
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Expected recruitment start date
2016-01-05, 1394/10/15
Expected recruitment end date
2016-08-05, 1395/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peer educational program versus no education on self-efficacy in patients with multiple sclerosis a randomized clinical trial
Public title
Effect of peer educational program versus no education on self-efficacy in patients with multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age of 18 to 50 years; affected by multiple sclerosis.
Exclusion criteria: participating in the educational programs in the last previous six months; affected by other acute or chronic physical, mental, or psychological disorders; speech or hearing disorders; dependent to wheelchair; acute phase of the disease.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization: The patients will be randomly assigned to intervention and control groups by drawing lot.
Blinding: Not possible.
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 the Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Approval date
2015-12-25, 1394/10/04
Ethics committee reference number
IR.UMSHA.REC.1394.407
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
Assessing the patient's self-efficacy
Timepoint
before and one month after intervention
Method of measurement
using Shere questionnaire
Secondary outcomes
1
Description
Nothing
Timepoint
Nothing
Method of measurement
Nothing
Intervention groups
1
Description
Routine care plus 4 educational sessions for 60 minutes twice a week
Category
Treatment - Other
2
Description
Just routine care
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Farshchian Hospital
Full name of responsible person
Fatemeh Takarli
Street address
Farshchian Hospital, Mirzadeh Eshghi Ave.
City
Hamadan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research the Technology, Hamadan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Fatemeh Takarli
Position
Midwifery Student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
ftakarli2013@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
School of Nursing and Midwifery
Full name of responsible person
Nahid Mohammadi
Position
Nursing of Social Health
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Hamadan University of Medical Sciences, Shahid Fahmideh Ave.
City
Hamadan
Postal code
Phone
+98 81 3838 0535
Fax
Email
n.mohammadi46@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Epidemiology
Full name of responsible person
Dr Jalal Poorolajal
Position
Associate Professor
Other areas of specialty/work
Street address
School of Public Health, Hamadan University of Medical Sciences, Shahid Fahmideh Ave
City
Hamadan
Postal code
6517838695
Phone
+98 81 3364 0030
Fax
Email
poorolajal@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)