Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12619000500156
Ethics application status
Approved
Date submitted
25/03/2019
Date registered
27/03/2019
Date last updated
14/07/2022
Date data sharing statement initially provided
27/03/2019
Date results provided
6/08/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Frailty In Residential Sector Over Time (FIRST) Study
Scientific title
Frailty In Residential Sector Over Time (FIRST) Study: Confirming the Validity of the FRAIL-AC Scale
Secondary ID [1] 297801 0
None
Universal Trial Number (UTN)
Trial acronym
FIRST (Frailty In Residential Sector over Time)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frailty 312162 0
Condition category
Condition code
Public Health 310707 310707 0 0
Health service research

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
The FIRST Study is a 3 year prospective cohort study involving Resthaven Inc. and all 12 of its facilities including approximately 756 residential aged care residents living in South Australia.

The research involves the collection of a range of health data on medical status and diagnoses, malnutrition, mobility, qualify of life, quality of care, dementia, sleep, activities of daily living, strength and pain. This information will be collected at baseline and repeated 1 year later for trajectory analysis. Study nurses hired by Resthaven Inc. will be trained by the research team to obtain informed consent and undertake the data collection for this study.

The FIRST Study will also be used to validate a new frailty screening tool, the FRAIL-AC, which was developed specifically for its use in residential aged care. The FRAIL-AC is a 19 item screening tool, which is derivable from 3 validated instruments used in this study (Dementia Severity Rating Scale, Katz Activities of Daily Living Scale and the Quality Of Life Alzheimer’s Dementia Scale). We aim to confirm the predictive validity of this newly developed tool in this newly recruited cohort.

In addition, public health data containing medical information about mortality, hospital visits, treatment and health conditions, and the use of ambulance services will be collected at year 1, 2 and 3 using data linkage undertaking by SA NT DataLink. Medicare and Pharmaceutical Benefits Scheme data will be sought from the Department of Human Services.

This research will help to better determine the prevalence and progression of frailty in residential aged care, its associated health outcomes and health care costs.
Intervention code [1] 314042 0
Not applicable
Comparator / control treatment
The performance of the FRAIL-AC will be compared against our previously developed screening tool, the FRAIL-NH, as well as the previously developed 66-Item Frailty Index (FI). All tools are derivable from the validated instruments used in this study.
Control group
Active

Outcomes
Primary outcome [1] 319559 0
Frailty using the FRAIL-AC
Timepoint [1] 319559 0
Baseline and year 1
Primary outcome [2] 319569 0
Frailty using the FRAIL-NH
Timepoint [2] 319569 0
Baseline and year 1
Primary outcome [3] 319570 0
Frailty using the 66-Item Frailty Index (FI)
Timepoint [3] 319570 0
Baseline and year 1
Secondary outcome [1] 368706 0
Malnutrition using the Mini Nutritional Assessment Short Form (MNA-SF) - primary outcome
Timepoint [1] 368706 0
Baseline and year 1
Secondary outcome [2] 368707 0
Activities of daily living using the Katz Activities of Daily Living Scale (KATZ ADL) - primary outcome
Timepoint [2] 368707 0
Baseline and year 1
Secondary outcome [3] 368708 0
Pain using the Pasero Opioid Induced Sedation Scale (POSS) - primary outcome


Timepoint [3] 368708 0
Baseline and year 1
Secondary outcome [4] 368709 0
Pain using the Pain Assessment in Advanced Dementia (PAINAD) - primary outcome
Timepoint [4] 368709 0
Baseline and year 1
Secondary outcome [5] 368710 0
Strength using the Martin Vigorimeter - primary outcome
Timepoint [5] 368710 0
Baseline and year 1
Secondary outcome [6] 368711 0
Quality of care using the Consumer Choice Index 6 Dimension (CCI-6D) - primary outcome
Timepoint [6] 368711 0
Baseline and year 1
Secondary outcome [7] 368712 0
Quality of life using the Personal Wellness Index (PWI) - primary outcome
Timepoint [7] 368712 0
Baseline and year 1
Secondary outcome [8] 368713 0
Quality of life using the Quality of Life in Alzheimer’s Disease Scale (QoL-AD) - primary outcome
Timepoint [8] 368713 0
Baseline and year 1
Secondary outcome [9] 368714 0
Sleep quality using the Epworth Sleepiness Scale (ESS) - primary outcome
Timepoint [9] 368714 0
Baseline and year 1
Secondary outcome [10] 368715 0
Sleep quality using one question from the Sleep Quality Questionnaire - primary outcome
Timepoint [10] 368715 0
Baseline and year 1
Secondary outcome [11] 368716 0
Depression and anxiety using the PHQ-4 questionnaire - primary outcome
Timepoint [11] 368716 0
Baseline and year 1
Secondary outcome [12] 368734 0
Sarcopenia using the SARC-F - primary outcome
Timepoint [12] 368734 0
Baseline and year 1
Secondary outcome [13] 368735 0
Mobility using the Nursing Home Life Space Diameter (NHLSD) - primary outcome
Timepoint [13] 368735 0
Baseline and year 1
Secondary outcome [14] 368736 0
Dementia using the Dementia Severity Rating Scale (DSRS) - primary outcome
Timepoint [14] 368736 0
Baseline and year 1
Secondary outcome [15] 368737 0
Number of falls using residents' facility reports over the past 12 months - primary outcome
Timepoint [15] 368737 0
Baseline and year 1
Secondary outcome [16] 368738 0
Polypharmacy using residents' medication and warfarin chart - primary outcome
Timepoint [16] 368738 0
Baseline and year 1
Secondary outcome [17] 368739 0
South Australian Death Registry including date of death provided by SA NT DataLink - secondary outcome
Timepoint [17] 368739 0
Year 1, 2 and 3
Secondary outcome [18] 368740 0
Public Hospital Emergency Department Data Collection (EDDC) including emergency presentations (triage category and length of stay) provided by SA NT DataLink - secondary outcome
Timepoint [18] 368740 0
Year 1, 2 and 3
Secondary outcome [19] 368741 0
Public Hospital Inpatient Separations (ISAAC) data including hospital overnight and day admissions (dates/time admitted and dates/time discharged) provided by SA NT DataLink - secondary outcome
Timepoint [19] 368741 0
Year 1, 2 and 3
Secondary outcome [20] 368742 0
South Australian Ambulance Service (SAAS) data including ambulance transportation costs and health information (as it becomes available) provided by SA NT DataLink - secondary outcome
Timepoint [20] 368742 0
Year 1, 2 and 3
Secondary outcome [21] 368743 0
Medicare Benefits Scheme (MBS) data including doctor visits and associated costs provided by the Department of Human Services - secondary outcome
Timepoint [21] 368743 0
Year 1, 2 and 3
Secondary outcome [22] 368744 0
Pharmaceutical Benefits Scheme (PBS) data including information on prescription medications provided by the Department of Human Services - secondary outcome
Timepoint [22] 368744 0
Year 1, 2 and 3

Eligibility
Key inclusion criteria
All permanent (i.e. respite or transition care program excluded) residents of the aged care facilities who are living in the facility for at least 8 weeks.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those deemed by clinical staff to be medically unstable (e.g. experiencing delirium) or estimated by facility staff to have less than 3 months to live.
Residents where the Manager Residential Services deems it inappropriate.
Those not fluent in English or who have difficulty understanding English and where staff members or interpreters are not available to translate.

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis
A range of statistical analysis methods will be employed on the data obtained over time in this prospective study. The statistical analyses methods used will cover both descriptive and analytic methods that will allow us to answer key questions on the problems of frailty and disability. Chi-square tests and Cochran-Armitage trend tests for example may be used to compare categorical variables. Wilcoxon rank sum tests may be used to compare continuous variables with skewed distributions. Regression models (e.g. linear, Poisson, Cox etc.) will also be applied. Kaplan-Meier analyses may be used to determine the cumulative percentage of participants hospitalised or deceased over the various follow-up time points. We have epidemiologists as well as statisticians on our team of investigators who will provide advice with regards to the statistical methods required for the various aims and the examples provided above are not exhaustive.

A sample size of n=716 has been calculated for logistic regression based on G-Power, which will also provide an adequate sample size for other analyses in the study. Conservatively, we anticipate a 60% recruitment rate from 1259 residents= 756 residents. We expect a mortality rate of 25% with at least 567 people followed up at year 1.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
28/03/2019
Actual
28/03/2019
Date of last participant enrolment
Anticipated
28/09/2019
Actual
28/10/2019
Date of last data collection
Anticipated
28/10/2022
Actual
Sample size
Target
756
Accrual to date
Final
588
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 302325 0
Government body
Name [1] 302325 0
Premier’s Research and Industry Fund - Government of South Australia
Country [1] 302325 0
Australia
Primary sponsor type
University
Name
University of Adelaide
Address
Discipline of Medicine
28 Woodville Road
Woodville South, SA 5011
Country
Australia
Secondary sponsor category [1] 302206 0
Commercial sector/Industry
Name [1] 302206 0
Resthaven Inc.
Address [1] 302206 0
6 Bartley Cres, Wayville SA 5034
Country [1] 302206 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302998 0
University of Adelaide Human Research Ethics Committee
Ethics committee address [1] 302998 0
Ethics committee country [1] 302998 0
Australia
Date submitted for ethics approval [1] 302998 0
10/08/2018
Approval date [1] 302998 0
08/11/2018
Ethics approval number [1] 302998 0
H-2018-247

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

Contacts
Principal investigator
Name 92122 0
Prof Renuka Visvanathan
Address 92122 0
The Queen Elizabeth Hospital
Discipline of Medicine, Adelaide Medical School, University of Adelaide
28 Woodville Road
Woodville SA 5011
Country 92122 0
Australia
Phone 92122 0
+61 8 82228178
Fax 92122 0
Email 92122 0
[email protected]
Contact person for public queries
Name 92123 0
Agathe Daria Jadczak
Address 92123 0
The Basil Hetzel Institute for Translational Health Research
37a Woodville Road
Woodville SA 5011
Country 92123 0
Australia
Phone 92123 0
+61 8 81334012
Fax 92123 0
Email 92123 0
[email protected]
Contact person for scientific queries
Name 92124 0
Agathe Daria Jadczak
Address 92124 0
The Basil Hetzel Institute for Translational Health Research
37a Woodville Road
Woodville SA 5011
Country 92124 0
Australia
Phone 92124 0
+61 8 81334012
Fax 92124 0
Email 92124 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


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
SourceTitleYear of PublicationDOI
EmbaseLife-Space Mobility in Aged Care Residents: Frailty In Residential Sector over Time (FIRST) Study Findings.2022https://dx.doi.org/10.1016/j.jamda.2022.04.013
N.B. These documents automatically identified may not have been verified by the study sponsor.