Protocol summary

Summary
The aim of this study was to investigate the effect of self care education on the quality of life of multiple sclerosis patients. 80 multiple sclerosis patients from shiraz multiple sclerosis society were enrolled to receive eight sessions of self care educational program for three months. Primary outcome was quality of life patient's.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2012120811691N1
Registration date: 2013-03-03, 1391/12/13
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-03-03, 1391/12/13
Registrant information
Name
Fariba Ghodsbin Jahromi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4250
Email address
ghodsbin@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2011-05-24, 1390/03/03
Expected recruitment end date
2011-08-25, 1390/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of self care education on quality of life of MS patient
Public title
Effect of self care education on quality of life of MS patient
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Presence of multiple sclerosis; ability to read and write Exclusion criteria: Presence of other diseases such as mental disorde; rcognitive disorde;raddiction; or other neurology
Age
No age limit
Gender
Both
Phase
N/A
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Medical Research Ethics Committee of Shiraz University of Medical Sciences
Street address
Shiraz
City
Shiraz
Postal code
Approval date
2010-11-11, 1389/08/20
Ethics committee reference number
07116474250

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
Immediately after the intervention
Method of measurement
using of qol questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
The self care education to Intervention group for 10 weeks.
Category
Lifestyle

2

Description
control group no intervention
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
MS Instito
Full name of responsible person
Fariba Ghodsbin
Street address
Square Namazi, Shiraz
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Deputyof Shiraz University of Medical Sciense
Full name of responsible person
Dr Gholam Reza Hattam
Street address
Square Namazi, Shiraz
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputyof Shiraz University of Medical Sciense
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
Shiraz University Medicine Sciences.
Full name of responsible person
Fariba Ghodsbin
Position
Masters Field
Other areas of specialty/work
Street address
Square Namazi, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4250
Fax
+98 71 1647 4250
Email
ghodsbin@sums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fariba Ghodsbin
Position
MS Nursing
Other areas of specialty/work
Street address
Square Namazi, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4250
Fax
Email
GHODSBIN@SUMS.AC.IR
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Esmail Parsayee Manesh
Position
Master of sciense
Other areas of specialty/work
Street address
Square Namazi, Shiraz
City
Shiraz
Postal code
Phone
+98 71 1647 4250
Fax
Email
salary_e@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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