Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610001049066
Ethics application status
Approved
Date submitted
17/06/2010
Date registered
30/11/2010
Date last updated
30/11/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Using Personal and environmental resources to reduce falls risk for older people with dementia
Scientific title
A pilot randomised trial of a functional cognitive framwork used to tailor fall prevention envrionmental and exercise intervention components to reduce falls risk in community-residing people with dementia .
Secondary ID [1] 252361 0
Nil
Universal Trial Number (UTN)
Trial acronym
I-FOCIS Intervention-Falls prevention for older people with cognitive impairment
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls prevention in older people with dementia 256473 0
Condition category
Condition code
Injuries and Accidents 256641 256641 0 0
Other injuries and accidents
Neurological 258035 258035 0 0
Dementias
Public Health 258036 258036 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The i-FOCIS intervention will encompass:
1. Assessing functional cognition to determine personal resources; fall risk factors using evidence–based protocol; and, daily routines and preferred activities by interview.
2. Based on the assessment, developing tailored and prioritized intervention goals:
a. Identifying and modifying environmental risk factors and simplifying environmental press to match cognitive abilities.
b. Providing exercise and functional tasks matched to capacity that will improve balance and increase lower limb strength.
c. Developing personal strategies to address safety and behavioral risk factors by focusing on meaningful activity that is associated with a high risk of falling for the individual (e.g., task analysis and simplification).
d. Training for caregiver in the above problem solving strategies and generic principles of risk reduction, and in specific communication strategies to facilitate management of the person and environment and ongoing engagement in falls prevention.
The planned program is four occupational therapy visits of 1-2hours duration and 4 physiotherapy visits of 1-1.5 hours duration, plus three follow up phone calls. The sessions will finish in the 12th week and be more frequent over the first 6 weeks.
Intervention code [1] 255758 0
Prevention
Comparator / control treatment
No-intervention control- The control subjects will not receive an intervention.
Control group
Active

Outcomes
Primary outcome [1] 258633 0
Physical activity measure: Hill step test, number of steps, timed
Timepoint [1] 258633 0
100 days post baseline assessment
Primary outcome [2] 258634 0
Adherence to program, 50% compliance to exercise and home safety recommendations by self report diary and survey
Timepoint [2] 258634 0
100 days post baseline assessment
Primary outcome [3] 258635 0
Caregiver coping skills- Task Management Strategy Index, mean score
Timepoint [3] 258635 0
100 days post baseline assessment
Secondary outcome [1] 262764 0
Physical Activity- questionnaire
Timepoint [1] 262764 0
100 days post baseline assessment
Secondary outcome [2] 262765 0
Daily living activities- self report, standardised interview format
Timepoint [2] 262765 0
100 days post baseline assessment
Secondary outcome [3] 262766 0
Caregiver Burden of care- standardised measure of caregiver burden, interview questionnaire
Timepoint [3] 262766 0
100 days post baseline assessment
Secondary outcome [4] 262768 0
Depression- standardised measure - interview questionnaire
Timepoint [4] 262768 0
100 days post baseline assessment

Eligibility
Key inclusion criteria
Diagnosed with dementia
Have a main caregiver who has a ninimum of 3.5 hours face to face weekly contact
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Diagnosed delerium
Severe psychiatric disorder
Parkinson's Disease
Living in a nursing home or hostel

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)
Randomisation conducted by investigator not involved in the intervention. Placed in opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted blocks of various sizes.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
control, no intervention
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
9/08/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 3003 0
2031
Recruitment postcode(s) [2] 3004 0
2032
Recruitment postcode(s) [3] 3005 0
2033

Funding & Sponsors
Funding source category [1] 257147 0
Charities/Societies/Foundations
Name [1] 257147 0
US Alzheimers Association
Country [1] 257147 0
United States of America
Funding source category [2] 257148 0
Commercial sector/Industry
Name [2] 257148 0
Alzheimer's Australia
Country [2] 257148 0
Australia
Primary sponsor type
University
Name
Prince of Wales Medical Research Institute
Address
Prince of Wales Medical Research Institute
Barker Street
Randwick
Sydney
NSW 2031
Country
Australia
Secondary sponsor category [1] 256408 0
University
Name [1] 256408 0
University of Sydney
Address [1] 256408 0
East St
Lidcombe
NSW 1825
Country [1] 256408 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258336 0
Human Research Ethics Committee- Northern Hospital Network
Ethics committee address [1] 258336 0
Room G71 East Wing
Edmund Blacket Bldg
Prince of Wales Hospital
Cnr High and Avoca Streets
Randwick, NSW 2031
Ethics committee country [1] 258336 0
Australia
Date submitted for ethics approval [1] 258336 0
Approval date [1] 258336 0
07/08/2009
Ethics approval number [1] 258336 0
1/09/0063

Summary
Brief summary
Seventy to eighty-five percent of people with cognitive impairment fall each year. This alarming rate is twice that seen in cognitively normal older people. In addition, people with cognitive impairment and dementia are at increased risk of serious injury and have a poorer prognosis following a fall. Falling in older age can markedly change an individual’s health trajectory, having debilitating and isolating consequences. Falls can start a downward spiral of immobility, reduced confidence and incapacity leading to institutionalization, and can be a cause of premature death. Typically, fall studies conducted with community-residing people exclude those with cognitive impairment. Thus little is known about how to best conduct falls prevention in this population.
This project will refine, trial and pilot a program that integrates the known evidence for falls prevention for environmental adaptation along with a dementia-specific approach to safe activity engagement in fall risk situations. Assessment of functional abilities and functional cognition will be conducted using Allen’s Cognitive Disability Model of practice. This will frame the intervention which will utilise the older person’s personal and environmental resources to make adaptations to the environment and behaviours that will significantly reduce their risk of falling.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30662 0
Address 30662 0
Country 30662 0
Phone 30662 0
Fax 30662 0
Email 30662 0
Contact person for public queries
Name 13909 0
Lindy Clemson
Address 13909 0
University of Sydney
East St
Lidcombe
NSW 1825
Country 13909 0
Australia
Phone 13909 0
+61 2 9351 9372
Fax 13909 0
Email 13909 0
[email protected]
Contact person for scientific queries
Name 4837 0
Lindy Clemson
Address 4837 0
University of Sydney
East St
Lidcombe
1825
Country 4837 0
Australia
Phone 4837 0
+61 2 9351 9372
Fax 4837 0
Email 4837 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.