Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001651279
Ethics application status
Approved
Date submitted
1/10/2018
Date registered
5/10/2018
Date last updated
5/10/2018
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cost-effectiveness of Community-Based Rehabilitation (CBR) Programme for Disabled Children: A comparative study between Centre-Based versus Home-Based
Scientific title
Cost-effectiveness of Community-Based Rehabilitation (CBR) Programme for Disabled Children: A comparative study between Centre-Based versus Home-Based
Secondary ID [1] 295323 0
None
Universal Trial Number (UTN)
U1111-1221-5476
Trial acronym
None
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Disability 309856 0
Condition category
Condition code
Public Health 308648 308648 0 0
Other public health

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Health outcomes and health-related quality of life were used to measure the health improvement among disabled children. Also, costing questionnaires were used to estimates costs incurred by parents, caregivers, and provider in managing disabled children in CBR programmes.

The disabled children and their parents and caregivers were involved in this study. Barthel Index assessment form, Developmental Disability Children Global Assessment Scale (DD-CGAS) and Health-Related Quality of Life (EQ-5D-3L:2) were used to assess health outcome of the disabled child and the duration is taken about 30 to 45 minutes per participant. While, for cost estimation, the costing questionnaires emphasized on expenditure for participated in CBR programmes was applied. The duration is taken about 30- 45 minutes per participant.
Intervention code [1] 312549 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 307608 0
Health outcomes measures were assessed using Barthel Index Score. A comparison between centre-based care and home-based care was carried out.


Timepoint [1] 307608 0
The assessment was conducted at enrolment for the previous 6 month period
Primary outcome [2] 307609 0
Health outcome also determined using Developmental-disability Children Global Assessment Scale (DD-CGAS).
Timepoint [2] 307609 0
The assessment was conducted at enrolment.
Secondary outcome [1] 352415 0
The quality of life of disabled children was assessed using E-Q-5-D-3L assessment to determine the quality of life.
Timepoint [1] 352415 0
This assessment was conducted during enrolment
Secondary outcome [2] 352416 0
The quality of life of disabled children was assessed using Visual Analog Scale from E-Q-5-D-3L form to illustrate the health condition from an imaginary thermometer scale.
Timepoint [2] 352416 0
This outcome also assessed at enrolment
Secondary outcome [3] 352418 0
Cost estimation for parents and caregivers were collected for 12 months expenses for CBR programme. The costs were from 2014 prices.

The participants costing diary was used to identify all expenditure by parents and caregivers for CBR programmes.
Timepoint [3] 352418 0
Assessed at enrolment for preceding 12 months
Secondary outcome [4] 352430 0
Costs estimation for provider were collected for 12 months expenses for CBR programme. The costs were from 2014 prices.

The costing data were collected from the administrative record and Activity-Based Costing (ABC) method.
Timepoint [4] 352430 0
Assessed at enrolment for preceding 12 months
Secondary outcome [5] 352431 0
Costs estimation for societal perspective in managing CBR programme for disabled children in 2014.

The societal cost was calculated from the combination of parents and caregivers costs with provider costs based on step-down costing and Activity-Based Costing (ABC) methods.
Timepoint [5] 352431 0
The costs were estimated at enrolment for preceding 12 months

Eligibility
Key inclusion criteria
All disabled children participated in CBR programmes, had registered with the department of social welfare were recruited as a participant to assess the health outcome.

For parents and caregivers who had disabled children that fulfill the inclusion criteria were selected as participants. were Automatically their parents and caregivers were recruited.

Providers were CBR centre selected randomly.
Minimum age
2 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Disabled children aged below or over the stated in inclusion criteria will be excluded in the study.

No limit age for parents and caregivers. The exclusion of age was applied to their child.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Convenience sample
Timing
Both
Statistical methods / analysis
A qualitative analysis was done for the data collected. Data were analyzed using Statistical Package for Social Sciences ® (IBM-SPSS) version 20.0. Health outcomes measures and cost estimation were analyzed using chi-square test and Mann Whitney test. Data were illustrated in median (IQR) value. P-values less than 0.05 were considered as statistically significant.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
2/03/2015
Date of last participant enrolment
Anticipated
Actual
4/04/2016
Date of last data collection
Anticipated
Actual
1/09/2016
Sample size
Target
342
Accrual to date
Final
297
Recruitment outside Australia
Country [1] 20885 0
Malaysia
State/province [1] 20885 0
Pahang
Country [2] 20886 0
Malaysia
State/province [2] 20886 0
Terengganu
Country [3] 20887 0
Malaysia
State/province [3] 20887 0
Kelantan

Funding & Sponsors
Funding source category [1] 299912 0
Government body
Name [1] 299912 0
Ministry of Education Malaysia
Country [1] 299912 0
Malaysia
Primary sponsor type
Individual
Name
Prof. Dato'. Dr. Syed Mohamed Aljunid Syed Junid
Address
International Centre for Casemix and Clinical Coding
Faculty of Medicine
Universiti Kebangsaan Malaysia
56000 Cheras
Kuala Lumpur, Malaysia
Country
Malaysia
Secondary sponsor category [1] 299280 0
None
Name [1] 299280 0
Address [1] 299280 0
Country [1] 299280 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 300781 0
University Kebangsaan Malaysia Ethic Committee
Ethics committee address [1] 300781 0
Ethics committee country [1] 300781 0
Malaysia
Date submitted for ethics approval [1] 300781 0
01/10/2014
Approval date [1] 300781 0
15/01/2015
Ethics approval number [1] 300781 0
FF-2015-004

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 3128 3128 0 0
/AnzctrAttachments/375436-FF-2015-004(1)ethic approval ukm-HALIZA.pdf (Ethics approval)

Contacts
Principal investigator
Name 84802 0
Prof Syed Mohamed Aljunid Syed Junid
Address 84802 0
International Centre for Casemix and Clinical Coding
Faculty of Medicine
Universiti Kebangsaan Malaysia
56000 Cheras
Kuala Lumpur, Malaysia
Country 84802 0
Malaysia
Phone 84802 0
+60126383512
Fax 84802 0
Email 84802 0
[email protected]
Contact person for public queries
Name 84803 0
Haliza Hasan
Address 84803 0
International Centre for Casemix and Clinical Coding
Faculty of Medicine
Universiti Kebangsaan Malaysia
56000 Cheras
Kuala Lumpur, Malaysia
Country 84803 0
Malaysia
Phone 84803 0
+60129871404
Fax 84803 0
Email 84803 0
[email protected]
Contact person for scientific queries
Name 84804 0
Syed Mohamed Aljunid Syed Junid
Address 84804 0
International Centre for Casemix and Clinical Coding
Faculty of Medicine
Universiti Kebangsaan Malaysia
56000 Cheras
Kuala Lumpur, Malaysia
Country 84804 0
Malaysia
Phone 84804 0
+60126383512
Fax 84804 0
Email 84804 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.