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Trial registered on ANZCTR


Registration number
ACTRN12614000603617
Ethics application status
Approved
Date submitted
2/06/2014
Date registered
6/06/2014
Date last updated
28/08/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment or dementia? A Randomised control Trial.
Scientific title
Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment or dementia? A Randomised control Trial.
Secondary ID [1] 284518 0
NIL
Universal Trial Number (UTN)
U1111-1156-2215
Trial acronym
i-FOCIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
cognitive impairment or dementia 291776 0
falls prevention 291777 0
Condition category
Condition code
Neurological 292141 292141 0 0
Dementias
Injuries and Accidents 292142 292142 0 0
Other injuries and accidents
Physical Medicine / Rehabilitation 292434 292434 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will consist of a 12 month home-based, individualised exercise and home hazard reduction program. There will be a combined total of 11 visits from the occupational therapist and physiotherapist, with the ratio of visits determined by the identified needs of participants. We anticipate the first 4 visits will occur on a weekly basis (Weeks 1-4) then the next 2 visits will occur (Weeks 7 and 9) to establish the intervention program. Following that the intervention visits will take place at the following intervals (Weeks 13, 17, 22, 36 and 48).

This will be supplemented by regular phone calls in between visits to the participant / carer to encourage continued engagement and identify any problems with either the exercise or environmental recommendations. We anticipate phone calls to occur on weeks (6, 11, 15, 19, 24, 27, 30, 33, 40 and 44).

Both the physio and OT will follow up recommendations made and upgrade programs as this is an important part of the intervention.

All participants in the intervention group will undergo the Allen's Cognitive Assessment. The Allen’s model of functional cognition will be used to guide the therapists in tailoring the interventions to the skills and abilities of the participants. The functional cognition results of participants will be discussed with their carers to enhance their knowledge about optimal ways of communicating with the participant and skills with regard to assisting implement the intervention. This important aspect will facilitate active participation of carers without increasing carer burden.

A home exercise program based on the Weight-bearing Exercise for Better Balance program will be established. The exercises will be individually prescribed by experienced physiotherapists and will target postural control (balance) and lower limb muscle strength. The participants will be asked to continue to exercises for the 12-month study period. The frequency and duration will be individually prescribed and will be up to 30 minutes 3-6 times a week. It is anticipated that the majority of the intervention group will be offered this intervention and tailored to the needs of the individual based on the results of the baseline physical and functional cognition assessments and in discussion with the participant and their carer.

Participants will be provided with a folder outlining the exercises recommended. The format of the exercises will be adjusted to accommodate the cognitive abilities of the participant, with instructions adapted accordingly, i.e. written information, written and pictorial information etc. and the exercises will be progressed under instruction from the physiotherapist over the intervention period.

The occupational therapist will undertake a detailed home safety assessment using the Westmead Home Safety Assessment and will provide advice and recommendations to optimise safety within the home. Recommendations following the assessment will be prioritised according to functional cognition of the participant, level of perceived risk and in negotiation with both the participant and carer. Typical recommendations will include removing/ securing loose mats, highlighting step edges with fluorescent tape, sensor lighting to illuminate walkways and bathrooms at night. Grab rails are commonly recommended and individuals will be referred to local home modifications services. Any recommendation for equipment will be done through the local hospital Equipment Lending Pool.

The carer education session is conducted by the occupational therapist (OT) in participants’ homes and provides support and education to carers. Some participants with dementia are present during the session, while other sessions are conducted with the carer only. These visits can also be conducted at the research office. These arrangements are determined by the carer prior to the session.

The session is informed by the functional cognition assessment and the falls behavioural risk factor assessment of the participant, and the Task Management Strategy Index (TMSI) completed by carers (which identifies strategies carers already use). This information is used to provide tailored strategies to help the carer engage with the exercise program. These include understanding participant cognitive abilities and implications for functional skills and behaviour in positive terms, as well as effective teaching and supervision skills according to the specific cognitive abilities of the participant. While these strategies are targeted to enhancing engagement with the program, they can often be generalised to other situations in everyday life.

This visit is flexible in terms of timing within the program – it is usually the fourth OT visit, and occurs after the third or fourth physiotherapy visit (week 17). Depending on the needs of the participants. The carer visit is always within the first six months of the protocol. It usually has a duration of one hour.

In addition the intervention group will be required to fill out monthly falls calendars for 12 months and have a baseline, 6 month and 12 month re-assessment.
Intervention code [1] 289281 0
Prevention
Intervention code [2] 289283 0
Behaviour
Comparator / control treatment
Participants allocated to the control group will receive the usual care provided by their health service providers. In addition they will be required to fill out monthly falls calendars for 12 months. They will have no contact with the study physiotherapist or occupational therapists. They will also be required to have a baseline assessment, 6 month and 12 month re-assessment.
Control group
Active

Outcomes
Primary outcome [1] 292018 0
Rate of falls in the control and intervention group over the 1 year follow up period.
Timepoint [1] 292018 0
1 year follow-up using monthly falls calendars for all participants
Secondary outcome [1] 308005 0
Quality of life.
Timepoint [1] 308005 0
Quality of life will be measured using the EQ5D-5L in both the participants and their carers at baseline, 6 months and 12 months reassessment and change compared in the control and intervention group overtime and their carers.
Secondary outcome [2] 308006 0
Physical activity level
Timepoint [2] 308006 0
Physical activity levels will be ascertained at baseline and at the 12 month reassessment using the Incidental and Planned Exercise Questionnaire (IPEQ) and will provide change compared in the control and intervention group over time.
Secondary outcome [3] 308007 0
Disability assessment for everyday functioning
Timepoint [3] 308007 0
Disability Assessment for Dementia screen will be used to assess everyday functioning at baseline and at the 12 month reassessment in study participants and change compared in the control and intervention group overtime.
Secondary outcome [4] 308008 0
Fear of falling
Timepoint [4] 308008 0
Fear of falling will be ascertained at baseline and at the 12 month reassessment using the Icon-FES and change compared in the control and intervention group over time.
Secondary outcome [5] 308334 0
Depression
Timepoint [5] 308334 0
The 15-item Geriatric Depression Scale will assess symptoms of depression at baseline and at the 12 month reassessment and compared in the control and intervention group over time.
Secondary outcome [6] 308335 0
Anxiety
Timepoint [6] 308335 0
The 9-item Goldberg Anxiety Scale will assess symptoms of generalized anxiety at baseline and at the 12 month reassessment and compared in the control and intervention group over time.
Secondary outcome [7] 308336 0
Neuropsychological performance
Timepoint [7] 308336 0
Changes in cognition will be assessed using the
*Frontal Assessment Battery,
*Mini mental and
*Addenbrooke's cognitive examination (ACER -R)
at baseline and at the 12 month reassessment and compared in the control and intervention group over time.
Secondary outcome [8] 308337 0
Physical performance measures
Timepoint [8] 308337 0
Physical performance will be measure using the
*Physiological Profile Assessment (measures visual contrast sensitivity, proprioception, quadriceps strength, simple reaction time, and postural sway while standing on a foam rubber mat with eyes open),
*Short form physical performance battery (measures sit to stand, balance and walking speed),
*Maximal balance (measures maximum AP lean) and *Coordinated stability

at baseline, 6 months and 12 months reassessment and compared in the control and intervention group over time.

Secondary outcome [9] 308338 0
Carer burden
Timepoint [9] 308338 0
Measured using the Zarit Burden of care Index at baseline and at the 12 month reassessment and compared in the control and intervention group over time.
Secondary outcome [10] 308339 0
Caregiver skill enhancement
Timepoint [10] 308339 0
Caregiver skill enhancement will be measured using the Task Management Strategy Index at baseline and at the 12 month reassessment and compared in the control and intervention group over time.
Secondary outcome [11] 308340 0
Adherence to exercise
Timepoint [11] 308340 0
Adherence to exercise measure using monthly exercise diaries
within 12 months follow-up period for each participant in the intervention group
Secondary outcome [12] 308343 0
Up take of home modifications
Timepoint [12] 308343 0
Up take of home modifications within 12 months follow-up period for each participant in the intervention group calculated as a percentage of recommendations.
Secondary outcome [13] 308344 0
Planned and unplanned use of health services
Timepoint [13] 308344 0
Health services measured using data collected from monthly diaries within 12 months follow-up period for each participant and compared in the control and intervention group over time.
Secondary outcome [14] 351194 0
Number of fallers in the control and intervention group over a 1 year follow up period
Timepoint [14] 351194 0
1 year follow up period using monthly falls calendars

Eligibility
Key inclusion criteria
* Sex: Males & Females
* 65 + years
* Living in the community
* MMSE<24 or ACE-R <83 or specialist clinical diagnosis of cognitive impairment or dementia
* Must have an identifiable and consenting person responsible and a carer (likely to be the person responsible in many cases) who have a minimum of 3.5 hrs hours of face to face contact with the participant each week for the purposes of reporting of falls and supervising the exercise intervention (3 times per week).
* Willingness of participant and carer to give informed consent and to participate in and comply with the study protocol. Proxy consent and participant assent will be used where participants cannot give informed consent.
Minimum age
65 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Participants with a MMSE < 12/30, as it is considered unlikely such people will be able to engage with the intervention
* Participants with the following medical conditions: delirium, acute medical illnesses, severe psychiatric disorders, progressive neurological diseases other than dementia and blindness
* Residents of residential aged care facilities
* Non-english speaking and no readily available interpreter
* People in existing dependent or unequal relationships
* People who are highly dependent on medical care
* People who may be involved in illegal activity

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)
Potential participants will be identified through a range of existing services including cognitive disorders and memory clinics.

At the initial home visit, the researcher will explain the study and provide a chance for the participant and their carer to ask questions. If both the person with cognitive impairment or dementia and the carer are agreeable to participate, then both will be asked to sign the relevant consent forms. If needed a person responsible may need to consent on behalf of the participant.

The participant and carer will be enrolled into the study after the informed consent process has been completed and the participant has met all inclusion criteria and none of the exclusion criteria. The participant will receive a study enrollment number and this will be documented in the participant’s study record and on all study documents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to intervention or control groups will occur after completion of the baseline assessment and will be stratified by site. Concealed randomisation will be performed centrally using a web-based randomisation service.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
Power analysis (with 5% significance levels, 80% power) has been undertaken using data from our previous work and similar studies. A total of 360 participants (180 per group) will provide 80% power to detect a significant 30% lower rate of falls for intervention participants than control participants (i.e. IRR = 0.70). We assumed alpha (measure of over-dispersion in negative binomial regression model) to be 0.8) and assumed the control group rate of falls would be 1.8 falls/person year over the 12-month follow-up period - based on our FOCIS cohort study. An average follow-up period of 11 months (rather than the planned 12 months) was used to account for loss to follow-up. A total of 360 participants will also allow us to detect a minimal increase of 5 points on the ADRQL (assuming control group mean of 79.7 and SD= 13.8) and provide us with over 90% power to detect between-group differences of the other measures.

An intention-to-treat approach will be used for all analyses. The number of falls per person-year in the intervention and control groups will be compared using negative binomial regression. This provides a more powerful analysis than a simple comparison of the proportion of fallers in the follow-up period, as it takes into account all falls during the trial, and also the distribution of falls, which is Poisson-like but has a fatter tail. General linear models will be used to assess the effect of group allocation on the continuously scored secondary outcome measures. Modified Poisson regression models will be used to compare groups on dichotomous outcome measures. Predictors of adoption and adherence will be analysed using multivariate modelling techniques such as multiple linear and logistic regression.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Lack of funding/staff/facilities
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 2385 0
Hornsby Ku-ring-gai Hospital - Hornsby
Recruitment hospital [2] 2386 0
Prince of Wales Hospital - Randwick
Recruitment hospital [3] 5474 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [4] 5475 0
The Sutherland Hospital - Caringbah
Recruitment hospital [5] 5476 0
St George Hospital - Kogarah
Recruitment postcode(s) [1] 8039 0
2031 - Randwick
Recruitment postcode(s) [2] 8040 0
2077 - Hornsby
Recruitment postcode(s) [3] 12958 0
2217 - Kogarah
Recruitment postcode(s) [4] 12959 0
2050 - Camperdown
Recruitment postcode(s) [5] 12960 0
2229 - Caringbah

Funding & Sponsors
Funding source category [1] 289158 0
Government body
Name [1] 289158 0
National Health and Medical Research Council, Australia
Address [1] 289158 0
Level 1
16 Marcus Clarke Street
Canberra ACT 2601

Postal National Health and Medical Research Council
GPO Box 1421
Canberra ACT 2601
Country [1] 289158 0
Australia
Primary sponsor type
Individual
Name
Professor Jacqueline Close
Address
Neuroscience Research Australia,
Barker Street, Randwick NSW 2031.

PO Box 1165, Randwick NSW 2031.

Country
Australia
Secondary sponsor category [1] 287828 0
Individual
Name [1] 287828 0
Professor Lindy Clemson
Address [1] 287828 0
Discipline of Occupational Therapy, Faculty of Health Sciences,
The University of Sydney; PO Box 170, Lidcombe, NSW 2141.
Country [1] 287828 0
Australia
Secondary sponsor category [2] 287829 0
Individual
Name [2] 287829 0
Professor Cathie Sherrington
Address [2] 287829 0
The George Institute for Global Health, The University of Sydney, PO Box M201, Missenden Rd, Sydney, NSW 2050.
Country [2] 287829 0
Australia
Secondary sponsor category [3] 287830 0
Individual
Name [3] 287830 0
Professor Keith Hill
Address [3] 287830 0
Curtin University, Building 408 Business and Physiotherapy
Kent St Bentley WA 6102.

GPO Box U1987
Perth WA 6845
Country [3] 287830 0
Australia
Secondary sponsor category [4] 287831 0
Individual
Name [4] 287831 0
Professor Sue Kurrle
Address [4] 287831 0
Hornsby Hospital,
Palmerston Rd
Department of Rehabilitation and aged care,
Hornsby NSW 2077.
Country [4] 287831 0
Australia
Other collaborator category [1] 277927 0
Individual
Name [1] 277927 0
Professor Stephen Lord
Address [1] 277927 0
Neuroscience Research Australia,
Barker Street, Randwick NSW 2031.

PO Box 1165 Randwick Sydney NSW 2031.
Country [1] 277927 0
Australia
Other collaborator category [2] 277928 0
Individual
Name [2] 277928 0
Professor Henry Brodaty
Address [2] 277928 0
Dementia Collaborative Research Centres (DCRC)
Room 302, Level 3
AGSM Building (G27)
University of New South Wales (UNSW)
NSW 2052.

Country [2] 277928 0
Australia
Other collaborator category [3] 277929 0
Individual
Name [3] 277929 0
Professor Laura Gitlin
Address [3] 277929 0
Johns Hopkins University
School of Nursing Center for Innovative Care in Aging
525 North Wolfe Street, Suite 316
Baltimore, MD 21205
Country [3] 277929 0
United States of America
Other collaborator category [4] 277930 0
Individual
Name [4] 277930 0
Professor Kirsten Howard
Address [4] 277930 0
School of Public Health, A27 Edward Ford Building,
The University of Sydney, Sydney, NSW 2006.
Country [4] 277930 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290931 0
South Eastern Sydney Local Health District Human Research Ethics Committee.
Ethics committee address [1] 290931 0
Research Support Office
HUMAN RESEARCH ETHICS COMMITTEE
Room G71 East Wing
Edmund Blacket building
RANDWICK NSW 2031
Ethics committee country [1] 290931 0
Australia
Date submitted for ethics approval [1] 290931 0
25/03/2014
Approval date [1] 290931 0
07/05/2014
Ethics approval number [1] 290931 0
14/046

Summary
Brief summary
There is currently no evidence indicating that it is possible to prevent falls in community dwelling older people with dementia despite this group having a disproportionately higher rate of falls and fractures and poorer outcomes post event.

However, there is evidence that a dementia specific approach to care, in which interventions are based on the individuals’ preserved abilities and in which the caregiver is provided with the skills to work effectively with the person with dementia, can be effective in improving daily function for the person with dementia and sense of competence for the carer.


The purpose is to investigate whether a home-based exercise program and home hazard reduction program can:
1) reduce the risk of falls in older people with cognitive impairment or dementia, and
2) improve the quality of life of the person with cognitive impairment or dementia and their carer(s).
Trial website
Trial related presentations / publications
Close JC, Wesson J, Sherrington C, Hill KD, Kurrle S, Lord SR, Brodaty H, Howard K, Gitlin LN, O'Rourke SD, Clemson L.

Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment: protocol paper for the i-FOCIS randomised controlled trial.
BMC Geriatr. 2014 Aug 15;14:89.
doi: 10.1186/1471-2318-14-89.
Public notes

Contacts
Principal investigator
Name 48038 0
Prof Jacqueline Close
Address 48038 0
Neuroscience Research Australia,
Barker Street, Randwick NSW 2031.

PO Box 1165
Randwick NSW 2031
Country 48038 0
Australia
Phone 48038 0
(612) 9399 1055
Fax 48038 0
(612) 9399 1204
Email 48038 0
j.close@neura.edu.au
Contact person for public queries
Name 48039 0
Mrs Sandra O'Rourke
Address 48039 0
Neuroscience Research Australia,
Barker Street, Randwick NSW 2031.
PO Box 1165
Randwick NSW 2031
Country 48039 0
Australia
Phone 48039 0
(612) 9399 1851
Fax 48039 0
(612) 9399 1204
Email 48039 0
s.orourke@neura.edu.au
Contact person for scientific queries
Name 48040 0
Mrs Sandra O'Rourke
Address 48040 0
Neuroscience Research Australia,
Barker Street, Randwick NSW 2031.

PO Box 1165
Randwick NSW 2031
Country 48040 0
Australia
Phone 48040 0
(612) 9399 1851
Fax 48040 0
(612) 9399 1204
Email 48040 0
s.orourke@neura.edu.au

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary