Protocol summary

Summary
The aim of this study was to investigate the effect of family-center empowerment model on knowledge, attitude and skill of the multiple sclerosis patients. 140 multiple sclerosis patients from Iranian multiple sclerosis society were enrolled to receive eight sessions of educational program based on educational needs for three months. Primary outcome was knowledge, attitude, and skill in care givers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201010272861N8
Registration date: 2010-11-02, 1389/08/11
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-11-02, 1389/08/11
Registrant information
Name
Reza Masoodi
Name of organization / entity
Nursing department, Shahrekord University of Medical Science,
Country
Iran (Islamic Republic of)
Phone
+98 38 1333 5654
Email address
masoodi@skums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research Assistant of Isfahan University of Medical Sciences and Health Services
Expected recruitment start date
2010-06-22, 1389/04/01
Expected recruitment end date
2010-07-23, 1389/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family center empowerment model on skill, attitude and knowledge of multiple sclerosis patients
Public title
Family center empowerment model on skill, attitude and knowledge of multiple sclerosis
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: Presence of multiple sclerosis, membership of Iranian multiple sclerosis center, ability to read and write Exclusion criteria: Presence of other diseases such as mental disorder, cognitive disorder, addiction, or other neurologic disorder
Age
From 20 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 140
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
Isfahan University of Medical Sciences and Health Services
Street address
Isfahan University of Medical Sciences and Health Services, Hezar jerib Ave.
City
Isfahan
Postal code
819570000
Approval date
empty
Ethics committee reference number
1112/آب/15

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Demyelinating diseases of the central nervous system

Primary outcomes

1

Description
Knowledge, Attitude, Skill
Timepoint
3 months
Method of measurement
Specific questionnaire

Secondary outcomes

1

Description
Quality of life
Timepoint
three months
Method of measurement
Specific questionnaire

Intervention groups

1

Description
Administration of family centered impowerment model for 3 months in trial group
Category
Rehabilitation

2

Description
Routine activities was done for control group
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan multiple sclerosis society
Full name of responsible person
Leili Rabiei
Street address
Isfahan multiple sclerosis society
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences and Health Services
Full name of responsible person
Leili Rabiei
Street address
Isfahan University of Medical Sciences and Health Services, higiene school
City
Isfahan
Grant name
1132
Grant code / Reference number
1210/JB
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Sciences and Health Services
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
Ahvaz Jundishapour University of Medical Sciences and health services
Full name of responsible person
Reza Masoodi
Position
PH.D
Other areas of specialty/work
Street address
Nursing PH.D
City
Ahvaz
Postal code
00983113738331
Phone
+98 31 1373 8331
Fax
+98 61 3571 5794
Email
rezamasoodi@ajums.ac.ir
Web page address
ajums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ph.D in Nursing and member of faculty
Full name of responsible person
Reza Masoodi
Position
Ph.D in Nursing
Other areas of specialty/work
Street address
Ahvaz Jundishapour University of Medical Sciences and health services
City
Ahvaz
Postal code
613571-5794
Phone
+98 61 1373 8331
Fax
+98 61 1373 8333
Email
rezamasoodi@ajums.ac.ir
Web page address
ajums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Master of Science student
Full name of responsible person
Leili Rabiei
Position
Master
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences and Health Services. Higeine school
City
Isfahan
Postal code
8195700000
Phone
+98 31 1435 6647
Fax
+98 31 1435 6646
Email
leila_rabiei@yahoo.com
Web page address
IUMS.AC>IR

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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