Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000676617
Ethics application status
Approved
Date submitted
13/09/2005
Date registered
21/10/2005
Date last updated
21/10/2005
Type of registration
Retrospectively registered

Titles & IDs
Public title
Functioning & Disability and Quality of Life in an Australian Community Cohorts with Multiple Sclerosis
Scientific title
Functional outcomes, disability and quality of life following rehabilitation in patients with multiple sclerosis
Secondary ID [1] 201 0
University of Melbourne HREC: University of Melbourne HREC No. 040334
Secondary ID [2] 202 0
Royal Melbourne Hospital HREC: Royal Melbourne Hospital HREC No. 2004.101
Universal Trial Number (UTN)
Trial acronym
MS Rehabilitation Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Multiple Sclerosis 824 0
Condition category
Condition code
Neurological 888 888 0 0
Multiple sclerosis
Physical Medicine / Rehabilitation 889 889 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Routine rehabilitation inervention in patients with MS. This comprises of medical and nursing input, physiotherapy, occupational therapy, speech pathology, neuropsychology, compared with a "control" group on the waiting list for rehabilitation intervention. Duration of intervention is 6 weeks.
Intervention code [1] 551 0
Rehabilitation
Comparator / control treatment
Control group
Active

Outcomes
Primary outcome [1] 1151 0
Improvement in fatigue levels in MS patients.
Timepoint [1] 1151 0
Outcome will be measured at 13 months since recruitment.
Primary outcome [2] 1152 0
Improvement in psychological well being including depression in MS patients.
Timepoint [2] 1152 0
Outcome will be measured at 13 months since recruitment.
Primary outcome [3] 1153 0
Improvement in fatigue levels and psychological well being including stress in MS patients.
Timepoint [3] 1153 0
Outcome will be measured at 13 months since recruitment.
Primary outcome [4] 1154 0
Improvement in psychological well being including anxiety in MS patients.
Timepoint [4] 1154 0
Outcome will be measured at 13 months since recruitment.
Secondary outcome [1] 2116 0
Improvement in function and activities of daily living ie. Disability
Timepoint [1] 2116 0
13 months follow up.
Secondary outcome [2] 2117 0
Quality of life
Timepoint [2] 2117 0
13 months follow up.
Secondary outcome [3] 2118 0
Carer Burder in multiple sclerosis
Timepoint [3] 2118 0
13 months follow up.
Secondary outcome [4] 2119 0
Utilisation of health services
Timepoint [4] 2119 0
13 months follow up.

Eligibility
Key inclusion criteria
Confirmed diagnosis of MS (Paty)- Community dwelling participants with known neurological and psychological deficits per EDSS groups. - Male and female participants.- Residing within 60kms of metropolitan Melbourne.- Have mobility problem.- Adequate cognition (KFS=2).
Minimum age
19 Years
Maximum age
64 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients residing in nursing home and other residential care.- Those with severe cognitive problems KFS>2.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
using opaque envelopes with patient ID numbers
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
using a computer statistical software program SPSS
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
3/12/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 981 0
Hospital
Name [1] 981 0
Royal Melbourne Hospital
Country [1] 981 0
Australia
Funding source category [2] 982 0
Charities/Societies/Foundations
Name [2] 982 0
AFRM RACP research fund for 2005
Country [2] 982 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
Country
Australia
Secondary sponsor category [1] 846 0
University
Name [1] 846 0
Department of Medicine, University of Melbourne
Address [1] 846 0
Country [1] 846 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2290 0
Royal Melbourne Hospital
Ethics committee address [1] 2290 0
Ethics committee country [1] 2290 0
Australia
Date submitted for ethics approval [1] 2290 0
Approval date [1] 2290 0
Ethics approval number [1] 2290 0
Ethics committee name [2] 2291 0
University of Melbourne
Ethics committee address [2] 2291 0
Ethics committee country [2] 2291 0
Australia
Date submitted for ethics approval [2] 2291 0
Approval date [2] 2291 0
Ethics approval number [2] 2291 0

Summary
Brief summary
This project seeks to study the impact of the WHO international classification of functioning and disability looking at contextural factors affecting people with MS. Secondly to provide specific targetted rehabilitation intervention to the identified problem areas reported by the MS cohort and further to measure and quantify the selected functional and social outcomes from rehabilitation intervention.

Specific research questions include:
- establishment of a database to document the prevelence of medical social and functional parameters for a community dwelling cohort of patients with MS.
- to study and compare the effects of disablement on everyday living activities and participation in these persons. This will be done by:
a. record the patient's perceived problems due to MS and their coping ability using an open ended questionnaire.
b. to determine the perspective of their partners/carers regarding problems living with MS.
c. determine the perspective of the treating general practitioner/neurologist regarding problems living with MS.
d. to determine the impact of these listed problems and the distress caused on these patients with measured effects on activities and participation using the WHO ICF classification.
- Determine burden of care for the partner/carer,
- Study the impact of fatigue in persons with MS in the everday activities of daily living and function.
- To measure the impact of defined personal factors such as (depression, anxiety, stress) on the everyday activities and participation.
- Measure the impact of defined environmental factors that affect function and participation in this group.
- Record a generic indicator of health status measure using a general health questionnaire.
- To ascertain self efficacy in this patient group and their carers.
- To provide targetted rehabilitation intervention for these identified problems and measure specific functional and social outcomes.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36042 0
Address 36042 0
Country 36042 0
Phone 36042 0
Fax 36042 0
Email 36042 0
Contact person for public queries
Name 9740 0
Fary Khan
Address 9740 0
Royal Melbourne Hospital
Royal Park Campus
Administration Building 21
34 - 54 Poplar Road
Parkville VIC 3052
Country 9740 0
Australia
Phone 9740 0
+61 3 83872000
Fax 9740 0
+61 3 83872506
Email 9740 0
[email protected]
Contact person for scientific queries
Name 668 0
Fary Khan
Address 668 0
Royal Melbourne Hospital
Royal Park Campus
Administration Building 21
34 - 54 Poplar Road
Parkville VIC 3052
Country 668 0
Australia
Phone 668 0
+61 3 83872000
Fax 668 0
+61 3 83872506
Email 668 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.