ANZCTR - Registration

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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 information initially provided

6/03/2020

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]

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

Condition category

Condition code

Public Health

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]

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]

Frailty using the FRAIL-AC

Timepoint [1]

Baseline and year 1

Primary outcome [2]

Frailty using the FRAIL-NH

Timepoint [2]

Baseline and year 1

Primary outcome [3]

Frailty using the 66-Item Frailty Index (FI)

Timepoint [3]

Baseline and year 1

Secondary outcome [1]

Malnutrition using the Mini Nutritional Assessment Short Form (MNA-SF) - primary outcome

Timepoint [1]

Baseline and year 1

Secondary outcome [2]

Activities of daily living using the Katz Activities of Daily Living Scale (KATZ ADL) - primary outcome

Timepoint [2]

Baseline and year 1

Secondary outcome [3]

Pain using the Pasero Opioid Induced Sedation Scale (POSS) - primary outcome

Timepoint [3]

Baseline and year 1

Secondary outcome [4]

Pain using the Pain Assessment in Advanced Dementia (PAINAD) - primary outcome

Timepoint [4]

Baseline and year 1

Secondary outcome [5]

Strength using the Martin Vigorimeter - primary outcome

Timepoint [5]

Baseline and year 1

Secondary outcome [6]

Quality of care using the Consumer Choice Index 6 Dimension (CCI-6D) - primary outcome

Timepoint [6]

Baseline and year 1

Secondary outcome [7]

Quality of life using the Personal Wellness Index (PWI) - primary outcome

Timepoint [7]

Baseline and year 1

Secondary outcome [8]

Quality of life using the Quality of Life in Alzheimer’s Disease Scale (QoL-AD) - primary outcome

Timepoint [8]

Baseline and year 1

Secondary outcome [9]

Sleep quality using the Epworth Sleepiness Scale (ESS) - primary outcome

Timepoint [9]

Baseline and year 1

Secondary outcome [10]

Sleep quality using one question from the Sleep Quality Questionnaire - primary outcome

Timepoint [10]

Baseline and year 1

Secondary outcome [11]

Depression and anxiety using the PHQ-4 questionnaire - primary outcome

Timepoint [11]

Baseline and year 1

Secondary outcome [12]

Sarcopenia using the SARC-F - primary outcome

Timepoint [12]

Baseline and year 1

Secondary outcome [13]

Mobility using the Nursing Home Life Space Diameter (NHLSD) - primary outcome

Timepoint [13]

Baseline and year 1

Secondary outcome [14]

Dementia using the Dementia Severity Rating Scale (DSRS) - primary outcome

Timepoint [14]

Baseline and year 1

Secondary outcome [15]

Number of falls using residents' facility reports over the past 12 months - primary outcome

Timepoint [15]

Baseline and year 1

Secondary outcome [16]

Polypharmacy using residents' medication and warfarin chart - primary outcome

Timepoint [16]

Baseline and year 1

Secondary outcome [17]

South Australian Death Registry including date of death provided by SA NT DataLink - secondary outcome

Timepoint [17]

Year 1, 2 and 3

Secondary outcome [18]

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]

Year 1, 2 and 3

Secondary outcome [19]

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]

Year 1, 2 and 3

Secondary outcome [20]

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]

Year 1, 2 and 3

Secondary outcome [21]

Medicare Benefits Scheme (MBS) data including doctor visits and associated costs provided by the Department of Human Services - secondary outcome

Timepoint [21]

Year 1, 2 and 3

Secondary outcome [22]

Pharmaceutical Benefits Scheme (PBS) data including information on prescription medications provided by the Department of Human Services - secondary outcome

Timepoint [22]

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?

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)

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

Premier’s Research and Industry Fund - Government of South Australia

Address [1]

Government of South Australia
Department for Industry and Skills
11 Waymouth Street
Adelaide SA 5000

Country [1]

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]

Commercial sector/Industry

Name [1]

Resthaven Inc.

Address [1]

6 Bartley Cres, Wayville SA 5034

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Adelaide Human Research Ethics Committee

Ethics committee address [1]

Research Services
The University of Adelaide
SA 5005

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

10/08/2018

Approval date [1]

08/11/2018

Ethics approval number [1]

H-2018-247

Summary

Brief summary

Research focusing on frailty in residential aged care services (RACS) is sparse. A better understanding of the relationship between frailty progression, residents’ use of life space and their perspectives on quality of care, combined with residents’ health data will help to better determine the progression of frailty, its associated health outcomes and costs, and assist in developing interventions that could improve the health circumstances of residential aged care residents in the long term.

The aims of this study are:
1. To confirm the validity of the FRAIL-AC in comparison to the FRAIL-NH and 66-Item FI
2. To describe the trajectory of frailty and its relationship with factors such as malnutrition, mobility, qualify of life, quality of care, dementia, sleep, activities of daily living, strength and pain
3. To investigate the association between frailty, hospitalisation, emergency department presentations and mortality via data linkage

Hypothesis:
We have recently investigated the frailty trajectory of older people living in the community and have demonstrated that frailty levels are dynamic with improvement and stability possible. Through this study, we aim to investigate if similar findings are present within RACS. We hypothesise that frailty and its trajectory may be associated with characteristics of the care provided in RACS to older adults.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Renuka Visvanathan

Address

The Queen Elizabeth Hospital
Discipline of Medicine, Adelaide Medical School, University of Adelaide
28 Woodville Road
Woodville SA 5011

Country

Australia

Phone

+61 8 82228178

Fax

[email protected]

Contact person for public queries

Name

Dr Agathe Daria Jadczak

Address

The Basil Hetzel Institute for Translational Health Research
37a Woodville Road
Woodville SA 5011

Country

Australia

Phone

+61 8 81334012

Fax

[email protected]

Contact person for scientific queries

Name

Dr Agathe Daria Jadczak

Address

The Basil Hetzel Institute for Translational Health Research
37a Woodville Road
Woodville SA 5011

Country

Australia

Phone

+61 8 81334012

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Study results article	Yes		Publication Date: 02/2021, Citation: Jadczak, AD; ... [More Details]

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Life-Space Mobility in Aged Care Residents: Frailty In Residential Sector over Time (FIRST) Study Findings.	2022	https://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.

Trial Review

Documents added manually

Documents added automatically