Protocol summary

Summary
The aim of this study was to investigate the effect of family-centered empowerment model on the quality of life of the care–givers of multiple sclerosis patients. 70 multiple sclerosis patients from Iranian multiple sclerosis society were enrolled to receive eight sessions of educational program based on educational needs of caregivers or no intervention for three months. Primary outcome was quality of life of care givers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138901162861N3
Registration date: 2010-05-04, 1389/02/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-05-04, 1389/02/14
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
Tarbiat Modares University
Expected recruitment start date
2006-04-21, 1385/02/01
Expected recruitment end date
2006-05-22, 1385/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of family-centered empowerment model on the quality of life of multiple sclerosis caregivers
Public title
The effect of family-centered empowerment model on the quality of life of multiple sclerosis caregivers
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 disorders
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
Tarbiat Modares University
Street address
Tarbiat Modares University, Gisha Bridge, Tehran
City
Tehran
Postal code
Approval date
empty
Ethics committee reference number
2124/م.ا

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
Quality of Life
Timepoint
3 months
Method of measurement
specific questionnaire

Secondary outcomes

1

Description
Caregivers Empoverment
Timepoint
3 months
Method of measurement
Questionnaire

Intervention groups

1

Description
Family-centered empoverment program on caregivers in intervention group
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Iranian Multiple Sclerosis center
Full name of responsible person
Reza Masoudi
Street address
Iranian Multiple Sclerosis center, Vesal St., Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Dr. Fatemeh Alhani
Street address
Medical Department, Gisha Bridge, Tehran,
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tarbiat Modares University
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

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Reza Masoodi
Position
PhD Student in Nursing
Other areas of specialty/work
Street address
Nursing department, nursing and midwifery college, Rahmatie, Shahrekord
City
Shahrekord
Postal code
8813833435
Phone
+98 3813335653316
Fax
+98 38 1334 6714
Email
masoodi@skums.ac.ir-masoodi1383@yahoo.com
Web page address
skums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahrekord University of Medical Sciences and Health Services
Full name of responsible person
Reza Masoodi
Position
Member of Faculty and Ph.D student in Nursing
Other areas of specialty/work
Street address
nursing department, nursing and midwifery college, Rahmatie, Shahrekord
City
Shahrekord
Postal code
Phone
+98 38 1333 5653
Fax
Email
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
Loading...