Trial from ANZCTR


Trial ID ACTRN12611000503921
Trial Status: Registered
Date Submitted: 19/04/2011
Date Registered: 13/05/2011
Retrospectively registered

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Public title Fit to be Left at Home - An alternate model of care to safely assess, intervene and prevent future falls and fall related injury in older people who are not transported to hospital after calling an ambulance as a result of a fall.
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Study title in 'Participant- Intervention- Comparator- Outcome (PICO)' format Fit to be Left at Home - An alternate model of care to safely assess, intervene and prevent future falls and fall related injury in older people who are not conveyed to hospital after calling an ambulance as a result of a fall.
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Secondary ID [1] 259771 0
Nil
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UTN U1111-1119-8974
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Trial acronym iPREFER
Intervention to PREvent Falls after Emergency Response
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Health condition(s) or problem(s) studied:
Falls in older adults 261352 0
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Fall related injury in older adults 261353 0
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Condition category: Condition code:
Injuries and Accidents Other injuries and accidents
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259511 259511 0 0
Public Health Health service research
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266008 266008 0 0

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Descriptions of intervention(s) / exposure The intervention group will be assessed for risk factors for falls and fractures. This will include medical and medication history, falls and fracture history, cognitive (GPCog) and physical function (IADL) and an objective measure of falls risk – QuickScreen. Physical activity will be measured using the IPAQ and the home environment will be assessed using the Homefast assessment scale. Quality of Life will be measured using the EQ5D and affect using the GDS-15. The anticipated duration of the initial assessment is approximately 60 minutes. At the end of the assessment, the researcher will generate a list of risk factors identified and written suggestions as to how they might be addressed using a template and capacity for free text to individualise some advice.
The intervention group will then receive falls prevention strategies based on risk factors identified. The clinical researcher will pro-actively work with the older person to ensure that risk factors are addressed and interventions carried out.
Exercise in the form of strength and balance training will be recommended and it is anticipated that the majority of the intervention group will be offered this intervention. This will be in the form of the Otago Exercise Program and delivered by the PACS service physiotherapist. Participants will also be referred on to local evidence-based exercise programs (not all delivered through health care) to ensure that they continue exercising on completion of the Otago Exercise Program.
Issues related to safety in the home environment will be referred to the PACS Occupational Therapist.
People with poor vision (and no recent visual assessment) will be referred to their usual eye-care provider or a local optometrist.
Participants taking medications known to increase falls risk will be referred to their GP and encouraged to discuss the ongoing need for these medications. A Home Medication Review will also be encouraged particularly where there is evidence of impaired cognition or any reported difficulties taking medications. A template will be designed to minimise any additional work for GPs. PACS nurses will ensure that appropriate changes are followed through and assist in any issues arising regarding medication
For complex patients with multiple problems, a referral to the POW falls clinic or POW aged care clinics will be organised. Again, a template will be designed to aid with the referral process and minimise additional work for the local GP.
Participants from the intervention group will be asked to fill out an Attitudes to Falls-Related Interventions Scale, to possibly identify and then address the specific concerns raised by particular individuals.
Participants will be reassessed after 6 months using a shorted version of the initial assessment tool. Assessment is estimated to take about 30-45 minutes. Reassessment will be completed by a researcher blinded to group allocation and will be conducted at the participants home. Further, participants will be followed up using monthly calendars and reply paid envelopes for a period of 12 months. Information will be collected with respect to falls, fall related injury, subsequent use of the ambulance service or hospital system and any visits to health care providers in the community. The monthly falls calenders are a single page questionnaire with only 2 questions. Participants are asked to fill it out either after using health care services or after having a fall, or at the end of the month if the participant did not fall. This process is estimated to take no more than 5 minutes.
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Intervention Code:
Early detection / Screening 264205 0
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Intervention Code:
Prevention 264206 0
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Comparator / control treatment The control group will receive standard ambulance care and will additionally be assessed for risk factors for falls and fractures. This will include medical and medication history, falls and fracture history, cognitive (GPCog) and physical function (IADL) and an objective measure of falls risk – QuickScreen. Physical activity will be measured using the IPAQ and the home environment will be assessed using the Homefast assessment scale. Quality of Life will be measured using the EQ5D and affect using the GDS-15. The anticipated duration of the initial assessment is approximately 60 minutes. At the end of the assessment, the researcher will generate a list of risk factors identified and written suggestions as to how they might be addressed using a template and capacity for free text to individualise some advice.
The control group will then receive a written copy of the risk factors identified during the baseline assessment. They will be encouraged to discuss the results with their local GP or other relevant health care provider.
Participants will be reassessed after 6 months using a shorted version of the initial assessment tool. Assessment is estimated to take about 30-45 minutes. Reassessment will be completed by a researcher blinded to group allocation and conducted at the participants home. Further, participants will be followed up using monthly calendars and reply paid envelopes for a period of 12 months. Information will be collected with respect to falls, fall related injury, subsequent use of the ambulance service or hospital system and any visits to health care providers in the community. The monthly falls calenders are a single page questionnaire with only 2 questions. Participants are asked to fill it out either after using health care services or after having a fall, or at the end of the month if the participant did not fall. This process is estimated to take no more than 5 minutes.
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Control group Active
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Primary Outcome: Number of falls in a 12 month follow up period (measured using falls calendar data) 262315 0
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Timepoint: monthly for 12 months for every participant 262315 0
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Primary Outcome: Number of fall related injuries in the 12 month follow up period, measured using falls calendar data on which participants are asked to record any falls including any injuries suffered. Further patient's health care service use will be recorded and retrieved using the Centre for Health Record Linkage, to which patients consent to at baseline. 262316 0
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Timepoint: monthly for 12 months for every participant 262316 0
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Secondary Outcome: Number of falls requiring ED attendance and/or hospitalisation (measured using calendar data and corroborated with NSW Centre for Health Record Linkage (CHeReL) data) 273518 0
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Timepoint: Within 12 months follow-up period for each participant 273518 0
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Secondary Outcome: Use of NSW Ambulance Service including time on scene (routinely collected Ambulance Service data) 273519 0
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Timepoint: Within 12 months follow-up period for each participant 273519 0
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Secondary Outcome: Any ED presentation or hospitalisation including DRG and LOS data (measured using calendar data and corroborated with CHeReL data) 273520 0
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Timepoint: Within 12 months follow-up period for each participant 273520 0
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Secondary Outcome: Use of community services, GP visits, HMRs, ACAT referrals, use of PACS services, specialists visits (measured using monthly calendar data) 273521 0
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Timepoint: Within 12 months follow-up period for each participant 273521 0
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Secondary Outcome: Uptake and adherence to recommendations, measured by a questionnaire with a three point scale which asks whether participants have followed recommendations completely, partially or not a all, for each individual recommendation listed following the baseline assessment. 273522 0
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Timepoint: At Baseline and 6 months assessment 273522 0
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Secondary Outcome: Quality of Life at baseline and follow-up measured using the EQ5D 273523 0
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Timepoint: At Baseline, 6 and 12 months 273523 0
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Secondary Outcome: Cost savings in regards to falls prevented, 000 call avoided, ED presentation avoided, hospital admission avoided, Quality adjusted life years gained. Cost savings are assessed from an institution's (hospital, the general health system etc) perspective 273524 0
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Timepoint: Assessed at 6 and 12 months for entire study duration 273524 0
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Secondary Outcome: Specific health service costs associated with this approach and cost savings due to health outcome improvements through implementing this approach. Cost savings are assessed from an institution's (hospital, the general health system etc) perspective 273525 0
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Timepoint: After 12 month study participation or until lost to follow-up. 273525 0
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Key inclusion criteria Elderly fallers, aged 65+
Attended to by ambulance service due to a fall
Not conveyed to hospital
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Minimum age 65 Years
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Maximum age No limit
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Gender Both males and females
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Healthy volunteers? No
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Key exclusion criteria Participants with cognitive impairment who do not have a regular carer because of the issue of consent and accurate recall of fall events
Participants with limited English language skills, who have no carer to translate for the duration of the study, which would prevent them from giving informed consent, complete assessments and understand instructions if in the intervention group.
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Study type Interventional
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Purpose of the study Prevention
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Allocation to intervention Randomised controlled trial
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Describe the procedure for enrolling a subject and allocating the treatment (allocation concealment procedures) Randomisation will occur after the baseline assessment has been undertaken but whilst the researcher is with the participant. Group allocation will be concealed from all study investigators and staff using consecutively numbered sealed opaque envelopes.
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Describe the methods used to generate the sequence in which subjects will be randomised (sequence generation) Randomisation will be achieved using computer generated random numbers and randomly permuted block sizes. The single centralised randomisation schedule will be developed by a colleague with no involvement in the study.
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Masking / blinding Blinded (masking used)
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Who is / are masked / blinded (choose all that apply)


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Assignment Parallel
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Other design features
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Type of endpoint(s) Safety/efficacy
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Statistical Methods/Analysis
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Phase Not Applicable
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Anticipated date of first participant enrolment 6/04/2011
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Date of first participant enrolment 7/04/2011
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Anticipated date last participant recruited/enrolled 30/04/2014
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Actual date last participant recruited/enrolled
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Target sample size 234
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Recruitment status Recruiting
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Recruitment in Australia

Recruitment state(s)
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Postcode: 2031 3867 0
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Postcode: 2035 3868 0
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Postcode: 2026 3869 0
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Postcode: 2020 3870 0
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Recruitment outside Australia

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Funding Source: Government body 264702 0
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Name: NSW Health Promotion Demonstration Research Grants Scheme 2010/2011 HP10/09 264702 0
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Address: NSW Health Department
Strategic Research and Development Branch
Centre for Health Advancement NSW Health
Locked Mail Bag 961
North Sydney
NSW 2059
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Country: Australia 264702 0
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Primary Sponsor Individual
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Name: Associate Professor Jacqueline Close
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Address: Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
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Country: Australia
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Secondary Sponsor: None 263834 0
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Other Collaborator: Individual 251881 0
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Name: Professor Stephen Lord 251881 0
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Address: Neuroscience Research Australia
Barker Street, Randwick, NSW 2031
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Country: Australia 251881 0
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Other Collaborator: Individual 251882 0
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Name: Dr Jason Bendall 251882 0
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Address: Ambulance Research Institute, Ambulance Service of NSW.
Level 1, Building 127 Church Street, Lilyfield
Rozelle, NSW, 2039
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Country: Australia 251882 0
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Other Collaborator: Individual 251883 0
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Name: Dr Anne Tiedemann 251883 0
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Address: The George Institute for International Health
Level 7, 341 George Street
Sydney NSW 2000
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Country: Australia 251883 0
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Other Collaborator: Individual 251884 0
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Name: Professor Gideon Caplan 251884 0
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Address: Prince of Wales Hospital
High Street, Randwick NSW 2031
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Country: Australia 251884 0
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Other Collaborator: Individual 251885 0
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Name: Dr Kirsten Howard 251885 0
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Address: University of Sydney
Edward Ford Building, A27
Camperdown, NSW 2006
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Country: Australia 251885 0
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Has the study received approval from at least one Ethics Committee? Yes
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Ethics Committee name: Royal Prince Alfred Hospital Ethics Review Committee 266697 0
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Address: Research Development Office Level 3, Building 92 Royal Prince Alfred Hospital Missenden Road CAMPERDOWN NSW 2050 266697 0
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Country: Australia 266697 0
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Approval Date: 11/02/2011 266697 0
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Submitted Date: 16/11/2010 266697 0
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HREC: HREC/10/RPAH/616 266697 0
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Brief summary In 2008-2009 the Ambulance Service of NSW responded to 672,000 emergency incidents. For the same period, “falls” was the reported problem to triple zero operators in almost 90,000 cases with those 65+ comprising 58% of all fallers. The non-conveyance rate for older fallers is 23% however little is known about the outcomes for these people. Work undertaken in the UK reported similar rates of non-conveyance and also demonstrated that 47% of older people not conveyed following a fall are re-attended by the Ambulance Service within two weeks.
This study proposes to test the hypothesis that: rapid, timely and tailored intervention in older people who are not conveyed to hospital following a fall will lead to a significant reduction in future falls, fall related injury and unplanned use of emergency and acute hospital services.
A randomised controlled trial design (n=234) will be used to test the impact of rapid access to a comprehensive assessment and intervention program. The study population will consist of people aged 65+ years who live in Randwick, Botany or Waverly, are attended by an ambulance as a result of a fall and who are considered to be appropriate to be left at home. Follow-up telephone contact will be made with all non-conveyed fallers initially to establish that there has been no acute deterioration in their health or level of function following their fall. Consenting patients will undergo a baseline assessment in their home within 72hrs of initial attendance and be provided with a written report with regard to falls risk factors identified.
Intervention: The intervention group will receive falls prevention strategies based on the risk factors identified. The clinical researcher will pro-actively work with the older person to ensure that risk factors are addressed and interventions carried out. This will involve close liaison with the local Post Acute Care Service who will be part of delivering interventions including an evidence based exercise program and home safety assessment.
Follow-up: Both the control and intervention groups will be followed up using monthly calendars and reply paid envelopes for a period of 6 months. Information will be collected with respect to falls, fall related injury, subsequent use of the ambulance service or hospital system and any visits to health care providers in the community. At the end of the six months, all participants will be reassessed by a researcher blinded to group allocation.
Outcomes: The primary outcome measure will be the number of fallers and falls in the 6 month follow up period (measured using falls calendar data)
Additional secondary outcome measures include: Number of falls requiring ED attendance and/or hospitalisation measured using calendar data and corroborated with NSW Centre for Health Record Linkage (CHeReL) data), Use of NSW Ambulance Service including time on scene (routinely collected Ambulance Service data) and re-attendance rates, Any ED presentation or hospitalisation including DRG and LOS data (measured using calendar data and corroborated with CHeReL data), Use of community services – GP visits, HMRs, ACAT referrals, use of PACS services etc (measured using monthly calendar data), Uptake and adherence to recommendations (based on initial and final assessments), Quality of Life at baseline and follow-up measured using the EQ5D
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Trial website nil
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Trial related presentations / publications nil
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Public Notes
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Principal Investigator
Title: A/Prof
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Name: Jacqueline Close
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Address: Neuroscience Research Australia, Barker Street Randwick NSW 2031
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Country: Australia
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Tel: +61 2 9399 1055
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Email: j.close@neura.edu.au
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Contact person for public queries
Title: A/Prof
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Name: Associate Professor Jacqueline Close
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Address: Neuroscience Research Australia Barker Street, Randwick NSW 2031
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Tel: +61 2 9399 1055
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Fax: +61293991204
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Email: j.close@neura.edu.au
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Contact person for scientific queries
Title: A/Prof
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Name: Associate Professor Jacqueline Close
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Address: Neuroscience Research Australia Barker Street, Randwick NSW 2031
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Tel: +61 2 9399 1055
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Fax: +61 2 93991204
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Email: j.close@neura.edu.au
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Contact person responsible for updating information
Title:
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Name: Associate Professor Jacqueline Close
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Address: Neuroscience Research Australia Barker Street, Randwick NSW 2031
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Tel: +61 2 9399 1055
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Fax: +61 293991204
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Email: j.close@neura.edu.au
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Addition Cancer fields
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