Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000838011
Ethics application status
Approved
Date submitted
28/09/2010
Date registered
6/10/2010
Date last updated
6/10/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Concord Falls and Bone Service Study: An evaluation of the effectiveness of a specialist service on reducing falls in community dwelling older people who have fallen.
Scientific title
In community-dwelling older people who have fallen, does the provision of falls prevention interventions and osteoporosis treatment through a specialist Falls and Bone service prevent more falls than care coordinated by General Practitioners.
Secondary ID [1] 252391 0
Nil
Universal Trial Number (UTN)
U1111-1116-7103
Trial acronym
CONFABS study (Concord Falls and Bone Service)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Accidental falls in the elderly 257902 0
Condition category
Condition code
Injuries and Accidents 258064 258064 0 0
Other injuries and accidents
Musculoskeletal 258217 258217 0 0
Osteoporosis
Public Health 258486 258486 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Specialist Falls and Bone service - coordinating targeted multifactorial falls prevention interventions and adequate assessment and treatment of osteoporosis. The falls prevention interventions are not the intervention of interest rather the service model to provide them.
The specialist service consists of a registered nurse who performs the baseline assessments. A geriatrician assesses participants in a hospital based clinic setting or domicilary visit. The first clinic visit lasts 90 minutes and includes a comprehensive geriatric medical assessment with focused clinical examination including gait and balance assessment with Timed Up and Go Test, Sit to Stand Times Five and Static Balance Assessment. Investigations performed at this clinic and ordered by the Geriatrician include blood tests to assess osteoporosis risk, Bone Mineral Denistometry (BMD), Computerised Tomography (CT) of the brain, x-rays of the thoraco-lumbo-sacral spine and 24 hour ambulatory blood pressure monitoring. The participant is seen again at 6 weeks, 4 months and 12 months after the initial assessment and seen initially within 2 weeks of randomization (aiming for 1 week). These subsequent visits will again be with a Geriatrician. At the week 6 visit the participant will have the results of the relevant investigations reviewed and treatment instituted, such as osteoporosis treatment according to national treatment guidelines including Calcium and Vitamin D supplementation. Falls prevention interventions will be coordinated and arranged by the Geriatrician with the assistance of community based physiotherapists, occupational therapists and podiatrists not employed by the research team per se. Telephone and postal communication with participants and their General Practitioner will be used to communicate changes in treatment. At the 4 month and 12 month visits the Geriatrician will review the falls prevention interventions employed and coordinate additional interventions depending on the outcome of these interventions. For example, should a participant wish to continue an exercise programme following the completion of a programme, community based classes will be sourced or the participant will be referred to a more complex class such as Tai Chi, if they were unable to participate in this previously. In addition, compliance with medication changes will be reviewed and additional changes made as necessary.
Intervention code [1] 256953 0
Prevention
Intervention code [2] 257314 0
Treatment: Drugs
Intervention code [3] 257315 0
Treatment: Other
Comparator / control treatment
General Practice (GP) coordinated use of targeted multifactorial falls prevention interventions. Enhanced GP service model with falls risk assessment and generic advice provided by the research team for coordination by the GP. The GP is the usual practitioner caring for the participant. There will be no specific GP education, but there exists ongoing education sessions given by the Principal Investigator to the local GP network as part of continuing medical education.
Control group
Active

Outcomes
Primary outcome [1] 258924 0
Number of falls (rate of falls)
Using monthly falls calendar to record falls and telephone follow-up phone calls.
Timepoint [1] 258924 0
12 months after randomisation
Primary outcome [2] 258925 0
Number of fallers
Using monthly falls calendar to record falls and telephone follow-up phone calls.
Timepoint [2] 258925 0
12 months after randomisation
Secondary outcome [1] 265096 0
Number of injurious falls (injurious fall rate) intervention versus control
Using monthly falls calendar to record falls and telephone follow-up phone calls. Details on the injuries sustained are obtained from follow-up phone calls and data linkage including hospital admissions, Emergency Department attendances and any investigations performed. Injurious falls will be defined as minor or major depending on the injury sustained and the treatment required by the research team in accordance with previously published definitions. For example lacerations or abrasions which do not require sutures or repeated dressings by community nurses would be termed a minor injury.
Timepoint [1] 265096 0
12 months after randomisation
Secondary outcome [2] 265367 0
All cause mortality (mortality rate) intervention versus control.
Using telephone follow-up phone calls and data linkage to New South Wales (NSW) Register of Births Deaths and Marriages and / or the Australian Institute of Health and Welfare National Death Index for deaths outside NSW.
Timepoint [2] 265367 0
12 months after randomisation
Secondary outcome [3] 265368 0
Number of fractures (fracture rate) intervention versus control
Using monthly falls calendar to record falls and telephone follow-up phone calls and data linkage to medical records.
Timepoint [3] 265368 0
12 months after randomisation
Secondary outcome [4] 265574 0
Admission rate to residential aged care facilities intervention versus control.
Using telephone follow-up phone calls and data linkage to medical records.
Timepoint [4] 265574 0
12 months after randomisation
Secondary outcome [5] 265575 0
Time to first fall intervention versus control
Using monthly falls calendar to record falls and telephone follow-up phone calls.
Timepoint [5] 265575 0
12 months after randomisation
Secondary outcome [6] 265576 0
Time to first injurious fall intervention versus control.
Using monthly falls calendar to record falls and telephone follow-up phone calls and data linkage to medical records.
Timepoint [6] 265576 0
12 months after randomisation
Secondary outcome [7] 265577 0
Emergency Department attendance rate intervention versus control.
Using monthly falls calendar to record falls and telephone follow-up phone calls and data linkage to medical records.
Timepoint [7] 265577 0
12 months after randomisation
Secondary outcome [8] 265578 0
Acute hospital admission rate intervention versus control.
Using monthly falls calendar to record falls and telephone follow-up phone calls and data linkage to medical records.
Timepoint [8] 265578 0
12 months after randomisation
Secondary outcome [9] 265749 0
Effect of intervention on rate of falls in subgroups of single fallers and recurrent fallers.
Using monthly falls calendar to record falls and telephone follow-up phone calls.
Timepoint [9] 265749 0
12 months after randomisation
Secondary outcome [10] 265750 0
Effect of intervention on rate of falls in subgroups of subjects 65 - 79 years and subjects 80 years and over.
Using monthly falls calendar to record falls and telephone follow-up phone calls.
Timepoint [10] 265750 0
12 months after randomisation
Secondary outcome [11] 265751 0
Effect of interventionon rate of falls in those with mild cognitive impairment (Mini Mental State Examination (MMSE) 20-24) and cognitively intact (MMSE 25 and above).
Using monthly falls calendar to record falls and telephone follow-up phone calls.
Timepoint [11] 265751 0
12 months after randomisation
Secondary outcome [12] 265752 0
Change in quality of life in intervention group versus control group.
Change in score of Short Form 12 (SF-12) Quality of Life Questionnaire.
Timepoint [12] 265752 0
12 months after randomisation
Secondary outcome [13] 265753 0
Change in Physical Activity Score of the Elderly (PASE) in intervention group versus control group.
Timepoint [13] 265753 0
12 months after randomisation
Secondary outcome [14] 265754 0
Qualitative assessment of bisphosphonate tolerability in the intervention group.
Gastrointestinal Experience Survey of the Osteoporosis Patient Treatment Satisfaction Survey at 4, 8 and 12 months.
Timepoint [14] 265754 0
4, 8 and 12 months after randomisation
Secondary outcome [15] 265755 0
Difference in bisphosphonate use in intervention group versus control group.
Telephone follow-up phone call asking about bisphosphonate use with baselines research nurse assessment identifying medication use initially.
Timepoint [15] 265755 0
12 months after randomisation
Secondary outcome [16] 265756 0
Qualitative assessment of appropriateness and compliance with exercise interventions in both groups.
Questionnaire on completion of exercise intervention. This questionnaire has been developed for use in a clinical trial coordinated by a peer group of researchers but has not been validated to date.
Timepoint [16] 265756 0
12 months after randomisation
Secondary outcome [17] 265757 0
Prevalence of postural hypotension on 24 hour ambulatory blood pressure monitoring in the intervention group
Timepoint [17] 265757 0
At 6 weeks following randomisation
Secondary outcome [18] 265758 0
Prevalence of subcortical ischaemic changes on computerised tomography (CT) of the brain
Timepoint [18] 265758 0
At 6 weeks following randomisation

Eligibility
Key inclusion criteria
1. One or more fall in the preceding 12 months
2. Community dwelling (house, flat, retirement village, hostel)
3. Independently mobile with or without walking aids
4. Resident within the study area for the following 12 months
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Cognitive impairment MMSE <20/30
2. Terminal illness with life expectancy less than 12 months
3. Parkinson’s Disease or other neurodegenerative conditions
4. Unable to understand participant information or consent in English
5. Comprehensive Geriatric Assessment in the preceding 12 months
6. Has not attended a General Practitioner in the preceding 12 months
7. No usual General Practitioner
8. Living outside the study area

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Potentially eligible subjects are recruited from Emergency Department and the community through referrals from health care professionals, or self referrals.
Allocation concealment was achieved by contacting the holder of the allocation schedule at central administration.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified permuted block randomisation using a computer program.
The strata used were:
1. age - 65-79 years and 80 years and older.
2. Fall history - one fall in the prior 12 months and 2 or more falls in the prior 12 months.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
13/09/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257640 0
Charities/Societies/Foundations
Name [1] 257640 0
Ageing and Alzheimer's Research Foundation
Country [1] 257640 0
Australia
Primary sponsor type
Other Collaborative groups
Name
Centre for Education and Research on Ageing
Address
Building 18
Concord Repatriation General Hospital
Hospital Road
Concord NSW 2139
Country
Australia
Secondary sponsor category [1] 256863 0
University
Name [1] 256863 0
University of Sydney
Address [1] 256863 0
Research Office
Level 6 Jane Foss Russell Building
City Road - Darlington Campus
The University of Sydney NSW 2006
Country [1] 256863 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259741 0
Sydney South West Area Health Service - Human Research and Ethics Committee - Concord Repatriation General Hospital (CRGH)
Ethics committee address [1] 259741 0
Ethics committee country [1] 259741 0
Australia
Date submitted for ethics approval [1] 259741 0
16/02/2010
Approval date [1] 259741 0
02/06/2010
Ethics approval number [1] 259741 0
HREC/10/CRGH/30 CH62/6/2010-024

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

Contacts
Principal investigator
Name 31485 0
Address 31485 0
Country 31485 0
Phone 31485 0
Fax 31485 0
Email 31485 0
Contact person for public queries
Name 14732 0
Dr Nichola Boyle
Address 14732 0
Centre for Education and Research on Ageing
Building 18
Concord Hospital
Hospital Road
Concord NSW 2139
Country 14732 0
Australia
Phone 14732 0
+61 2 9767 8356
Fax 14732 0
+61 2 9767 5419
Email 14732 0
[email protected]
Contact person for scientific queries
Name 5660 0
Dr Nichola Boyle
Address 5660 0
Centre for Education and Research on Ageing
Building 18
Concord Hospital
Hospital Road
Concord NSW 2139
Country 5660 0
Australia
Phone 5660 0
+61 2 9767 8356
Fax 5660 0
+61 2 9767 5419
Email 5660 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.