Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000056695
Ethics application status
Approved
Date submitted
21/07/2005
Date registered
1/08/2005
Date last updated
13/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Home versus centre-based rehabilitation of older community dwelling fallers
Scientific title
Domiciliary versus centre-based rehabilitation of older community dwellers: Randomised trial with economic evaluation
Secondary ID [1] 252680 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Falls 127 0
Condition category
Condition code
Injuries and Accidents 144 144 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 145 145 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Centre-based service: Group balance, functional training, education and upper limb training interventions for 2 hours once per week for 8 weeks. 3 modules: 1.Warm-up of modified Tai Chi, workstations of balance and lower limb strengthening exercises. 2. Verbal education and discussion group covers topics of falls prevention, promoting physical activity, National Nutritional Guidelines, relaxation, stress management, future planning. 3. Upper limb strengthening and functional activities
Intervention code [1] 46 0
Rehabilitation
Comparator / control treatment
Domiciliary service: Home visits by Community Rehabilitation Service (CRS) staff of 45-60mins duration, 1-2 per week for 8 weeks. Visits include 30-45 mins personalised exercises and education modules as for the group program. Patients from both groups will also receive a tailored home exercise program from the CRS physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 183 0
Health Related Quality of Life measured using EuroQol
Timepoint [1] 183 0
Measured at 8 weeks and 6 month folow up.
Secondary outcome [1] 405 0
Falls
Timepoint [1] 405 0
Measured at initial assessment, eight week and six month follow up.
Secondary outcome [2] 406 0
Cost-Benefit
Timepoint [2] 406 0
Measured at initial assessment, eight week and six month follow up.
Secondary outcome [3] 407 0
Timed Up and Go
Timepoint [3] 407 0
Measured at initial assessment, eight week and six month follow up.
Secondary outcome [4] 408 0
Step Test
Timepoint [4] 408 0
Measured at initial assessment, eight week and six month follow up.
Secondary outcome [5] 409 0
Frenchay Activities Index
Timepoint [5] 409 0
Measured at initial assessment, eight week and six month follow up.
Secondary outcome [6] 410 0
Abbreviated Mental Test Score
Timepoint [6] 410 0
Measured at initial assessment, eight week and six month follow up.

Eligibility
Key inclusion criteria
Informed consent from patient directly or next of kin if patient previously demonstrated cognitive impairment (Mini-Mental State Examination score < 23 / 30).12. Availability of transportation to QEII hospital or Inala Community Health Centre sites.
Minimum age
60 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Nursing home resident, Non-ambulant.

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)
Sealed envelopes used to conceal allocation. After initial assessments have been taken and consent obtained, the next envelope is taken from a box. Inside is either "group" or "domiciliary".
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generated by random number generator using Microsoft Excel. Simple randomisation method - no restriction
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/06/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
156
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 199 0
Hospital
Name [1] 199 0
QHealth
Country [1] 199 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
QHealth
Address
Queen Elizabeth II Jubilee Hospital (QEII) Kessels Road Coopers Plains 4108 Queensland
Country
Australia
Secondary sponsor category [1] 148 0
None
Name [1] 148 0
Nil
Address [1] 148 0
Country [1] 148 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 960 0
QEII Hospital Health Service District
Ethics committee address [1] 960 0
Ethics committee country [1] 960 0
Australia
Date submitted for ethics approval [1] 960 0
Approval date [1] 960 0
Ethics approval number [1] 960 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 36396 0
Address 36396 0
Country 36396 0
Phone 36396 0
Fax 36396 0
Email 36396 0
Contact person for public queries
Name 9235 0
Michelle Currin
Address 9235 0
Community Rehabilitation Service
Queen Elizabeth II Hospital Health Service District
Private Bag 2
Acacia Ridge QLD 4110
Country 9235 0
Australia
Phone 9235 0
+61 7 32756318
Fax 9235 0
Email 9235 0
[email protected]
Contact person for scientific queries
Name 163 0
Tracy Comans
Address 163 0
Community Rehabilitation Service
Queen Elizabeth II Hospital Health Service District
Private Bag 2
Acacia Ridge QLD 4110
Country 163 0
Australia
Phone 163 0
0411 295 986
Fax 163 0
Email 163 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.