Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000234718
Ethics application status
Not yet submitted
Date submitted
25/02/2013
Date registered
27/02/2013
Date last updated
27/02/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
TRialing Individualised Interventions to prevent FunctionaL decline in at-risk older adults (TRIIFL): A nested randomized controlled trial
Scientific title
The effectiveness of an individualised community-based intervention program, compared to usual care, to prevent functional decline in at-risk older adults.
Secondary ID [1] 282024 0
Nil
Universal Trial Number (UTN)
Trial acronym
TRIIFL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Functional decline 288472 0
Condition category
Condition code
Other 288818 288818 0 0
Conditions of unknown or disputed aetiology (such as chronic fatigue syndrome/myalgic encephalomyelitis)

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In line with a patient-centred philosphy an individualised lifestyle intervention program will be provided, following comprehensive assessment and functional goal setting by trained physiotherapists and/or occupational therapists. The intervention will be structured to meet individuals' needs and so the frequency of contacts per week and the overall duration of the program will vary (3 to 14 weeks). Intervention could include attendance at day therapy centres, exercise, fitness, balance-retraining and/or socialisation, organisation of home help or community care packages, motivational interviewing or counselling.
NOTE: This RCT will be nested within a larger longitudinal cohort study that will evaluate functional decline over 13 months in older people who present to an Emergency Dept with non-catastrophic illness. All participants will be assessed at 1, 4, 7 13 months. Those participants assessed at 1 month follow-up to be at risk for functional decline (Score of <55 on the Mental Componenet Score of the SF-12) will enter the RCT.
Intervention code [1] 286608 0
Lifestyle
Intervention code [2] 286609 0
Prevention
Intervention code [3] 286610 0
Early detection / Screening
Comparator / control treatment
No intervention, simply observed.
Control group
Active

Outcomes
Primary outcome [1] 288957 0
Functional decline.
Functional decline will be assessed as change from baseline measures for the following :
One or more falls increase from the baseline rate.
More than one event of hospitalisation from the baseline rate.
Functional change ie Decrease of one point in any item of the ADL instrument, or 2+ points decrease from baseline total iADL score, or any decrease in baseline score in the domains of home activities, doing laundry, shopping and getting places.
Scores decreasing from above median at baseline in either physical or mental domain, to below median in the SF12.
Any decrease in AQoL_4D.
Change to a more assistive gait aid (eg a one point stick to a four-pronged stick).
Change in living arrangements to more supported care.
Increased carer involvement.
Greater type and frequency of use of formal community services, or informal supports.
More frequent GP attendances.
Timepoint [1] 288957 0
At 4, 7 and 13 months
Secondary outcome [1] 301435 0
Functional ability as assessed through face-to-face survey at baseline (recruitment), and via telephone followups, using: Short Form-12 Health Survey (SF12),
Activities of Daily Living (ADLs),
Instrumental Activities of daily Living (IADL)
Timepoint [1] 301435 0
At baseline, 1, 4, 7 and 13 months
Secondary outcome [2] 301436 0
Mobility status and falls rates assessed from participants' self-reporting during face-to-face survey at baseline (recruitment), and via telephone at followups.
Timepoint [2] 301436 0
At baseline, 1, 4, 7 and 13 months
Secondary outcome [3] 301437 0
Quality of life assessed using the Assessment of Quality of Life Instrument (AQoL). Face-to-face survey at baseline (recruitment), and via telephone at followups.
Timepoint [3] 301437 0
At baseline, 1, 4, 7 and 13 months
Secondary outcome [4] 301438 0
Hospitalisation rates assessed through participants' self-reporting during face-to-face survey at baseline (recruitment), and via telephone at followups
Timepoint [4] 301438 0
At baseline, 1, 4, 7 and 13 months
Secondary outcome [5] 301439 0
Formal community supports will be assessed from participants' self-reporting during face-to-face survey at baseline (recruitment), and via telephone at followups.
Data will include type of supports in use (eg home nursing, domestic help, shopping), frequency of visits
Timepoint [5] 301439 0
At baseline, 1, 4, 7 and 13 months
Secondary outcome [6] 301456 0
Informal carer supports as assessed from participants' self-reporting during face-to-face survey at baseline (recruitment), and via telephone at lowups. This would include details of type of care provided (eg shopping, laundry, personal care) and frequency of visits.
Timepoint [6] 301456 0
At baseline, 1,4,7,13 months
Secondary outcome [7] 301457 0
Living arrangements assessed from participants' self-reporting during face-to-face survey at baseline (recruitment), and via telephone at followups
Timepoint [7] 301457 0
At baseline, 1,4, 7 and 13 months
Secondary outcome [8] 301458 0
General Practitioner (GP) visits (rate or number/month) as assessed from participants' self-reporting during face-to-face survey at baseline (recruitment), and via telephone at followups
Timepoint [8] 301458 0
Baseline, 1, 4, 7, 13

Eligibility
Key inclusion criteria
Aged 65 years or older.
Presented to an Emergency Department with non-catastrophic health conditions which will not result in admission to hospital for further care.
A score of <55 on the Mental Component Score of the SF12 instument one month after Emergency Department presentation.
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Suffering communicable diseases requiring isolation.
Current mental health crisis.
Under detention.
Diagnosis of dementia.
Unable to communicate in English.
Profoundly deaf (such as would limit telephone communication at follow-up).

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)
Concealled allocation will randomly allocate participants to the intervention or control arm. Allocation will involve contacting the holder of the allocation schedule who is at a central administration site.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computerised random numbers sequence will be used.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
The RCT will be nested within a larger longitudinal cohort study
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The study groups (arms) will be assessed at time of allocation for homogeneity in key socio-demographic characteristics and immutable factors (eg gender, age, schooling, postcode, diagnosis), and all baseline outcome measures.

Change over time in each outcome measure will be calculated using repeated measures ANOVA models, with study contact point, group and key demographic features as independent variables. Partial Least Squares models (PLS) using pathway analysis will be applied to the multiple outcome, immutable and mutable independent variables at each time point, to determine different spatial arrangements and the significant factors which impact on data clusters.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/03/2014
Actual
Date of last participant enrolment
Anticipated
31/07/2014
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
570
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 676 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 6416 0
5001 - Adelaide

Funding & Sponsors
Funding source category [1] 286798 0
Self funded/Unfunded
Name [1] 286798 0
Country [1] 286798 0
Australia
Primary sponsor type
University
Name
University of South Australia
Address
North Tce, Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 285588 0
None
Name [1] 285588 0
none
Address [1] 285588 0
NA
Country [1] 285588 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 288864 0
University of South Australia Human Research Ethics Committee
Ethics committee address [1] 288864 0
North Tce, Adelaide SA. 5000
Ethics committee country [1] 288864 0
Australia
Date submitted for ethics approval [1] 288864 0
29/03/2013
Approval date [1] 288864 0
Ethics approval number [1] 288864 0
Ethics committee name [2] 288865 0
Royal Adelaide Hospital Human Research Ethics Committee
Ethics committee address [2] 288865 0
RAH, North Tce, Adelaide, SA. 5000
Ethics committee country [2] 288865 0
Australia
Date submitted for ethics approval [2] 288865 0
29/03/2013
Approval date [2] 288865 0
Ethics approval number [2] 288865 0

Summary
Brief summary
The project will focus on older adults living independently in the community, and who are on the cusp of Functional Declune (FD). We will conduct a nested RCT within a 13 month longitudinal observational study. In the observational study we will apply a simple, previously untested quality of life screen to detect incipient Functional Decline, one month following an Emergency Dept presentation that did not result in an inpatient admission. Those individuals with low scores at the point of screening will enter the RCT, which will test the effectiveness of a novel, early, home-based, personalised program (compared with ‘usual care’) in arresting or slowing Functional Decline.
Trial website
Nil
Trial related presentations / publications
TBA
Public notes

Contacts
Principal investigator
Name 38134 0
Prof Karen Grimmer
Address 38134 0
University of SA
North Tce
Adelaide, SA. 5000
Country 38134 0
Australia
Phone 38134 0
+61 8 83022769
Fax 38134 0
Email 38134 0
karen.grimmer@unisa.edu.au
Contact person for public queries
Name 38135 0
Dr Julie Luker
Address 38135 0
University of SA
North Tce
Adelaide, SA. 5000
Country 38135 0
Australia
Phone 38135 0
+61 8 83022080
Fax 38135 0
Email 38135 0
julie.luker@unisa.edu.au
Contact person for scientific queries
Name 38136 0
Prof Karen Grimmer
Address 38136 0
University of SA
North Tce
Adelaide, SA. 5000
Country 38136 0
Australia
Phone 38136 0
+61 8 83022769
Fax 38136 0
Email 38136 0
karen.grimmer@unisa.edu.au

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.