Protocol summary

Summary
Purpose:Effect of web-based daily care training on the quality of life of caregivers of children with cerebral palsy study design: Single-blind clinical trial study population: Caregivers of children with cerebral palsy Inclusion criteria: caregiver_ Mother of a child with cerebral palsy who spent most time on child care_Children with cerebral palsy aged 4 to 12 years old living in Alborz province that clinical diagnosis of cerebral palsy registered in their clinical records; Moderate and severe cerebral palsy (gross motor function levels 3 to 5); caregiver have facilities and basic knowledge of using Internet (Declared access to the Internet at least one hour a week) exclusion criteria: taking care of two or more children with disability; participated in previous training programs Sample size: 100 Intervention: Web-based daily care training intervention time: a 12-week Outcome of the study: the quality of life of caregivers

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015082223710N1
Registration date: 2015-09-18, 1394/06/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2015-09-18, 1394/06/27
Registrant information
Name
Zahra Nobakht
Name of organization / entity
University Of Social Welfare And Rehabilitation Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0037
Email address
za.nobakht@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-02-20, 1394/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of web-based daily care training on the quality of life of caregivers of children with cerebral palsy
Public title
web-based daily care training of children with cerebral palsy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: caregiver_ Mother of a child with cerebral palsy who spent most time on child care_Children with cerebral palsy aged 4 to 12 years old living in Alborz province that clinical diagnosis of cerebral palsy registered in their clinical records; Moderate and severe cerebral palsy (gross motor function levels 3 to 5); caregiver have facilities and basic knowledge of using Internet (Declared access to the Internet at least one hour a week) exclusion criteria: taking care of two or more children with disability; participated in previous training programs
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

1

Registry name
clinicaltrials.gov PRS
Secondary trial Id
NCT02545179
Registration date
2015-09-09, 1394/06/18

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of the University of Social Welfare and Rehabilitation Science
Street address
Kodakyar Ave, Daneshjo Blvd, Evin, Post code: : 1985713834
City
Tehrak
Postal code
Approval date
2015-09-02, 1394/06/11
Ethics committee reference number
IR.USWR.REC.1394.111

Health conditions studied

1

Description of health condition studied
cerebral palsy
ICD-10 code
G80
ICD-10 code description
Cerebral palsy

Primary outcomes

1

Description
caregiver quality of life
Timepoint
pre and post
Method of measurement
sf36

Secondary outcomes

1

Description
pain, deppression , participation
Timepoint
pre and post
Method of measurement
DASS-21, LIFE-H

Intervention groups

1

Description
12 week interactive web based caring training
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rehabilitation Center
Full name of responsible person
Zahra Nobakht
Street address
City
Albors and Teharn

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Eskurchy Fatemeh
Street address
kodakyar Ave, Daneshjo Blvd, Evin, Post code: 1985713834
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Social Welfare and Rehabilitation 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
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Zahra Nobakht
Position
PhD Student
Other areas of specialty/work
Street address
kodakyar Ave, Daneshjo Blvd ,Evin, Post code: 1985713834
City
Tehran
Postal code
Phone
+98 21 2218 0083
Fax
Email
nobakht.zahra@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences
Full name of responsible person
Mehdi Rassafiani
Position
Assistant Professor
Other areas of specialty/work
Street address
kodakyar Ave, Daneshjo Blvd, Evin, Post code: 1985713834
City
Tehran
Postal code
Phone
+98 21222180008
Fax
Email
mrassafiani@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfar and Rehabilitation Sciences
Full name of responsible person
Zahra Nobakht
Position
PhD Student
Other areas of specialty/work
Street address
kodakyar Ave, Daneshjo Blvd, Evin, Post code: 1985713834
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0037
Fax
Email
nobakht.zahra@gmail.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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