ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

ACTRN12621000123842

Ethics application status

Approved

Date submitted

5/11/2020

Date registered

8/02/2021

Date last updated

23/02/2023

Date data sharing statement initially provided

8/02/2021

Type of registration

Prospectively registered

Titles & IDs

Public title

Activity levels of individuals admitted to an acute aged care ward after falling

Scientific title

Activity levels of individuals admitted to an acute aged care ward after falling

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1260-8693

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

falls

gerontology

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

Older adults admitted to the acute aged care ward at the Prince of Wales Hospital due to sustaining a fall will be recruited for this study. Once consent has been provided, participants will complete two functional outcome measures: Timed Up and Go (TUG) test (assesses functional mobility, balance, and fall risk in older adults), and Short Physical Performance Battery (SPPB) (assess lower extremity function, mobility, and physical performance in older adults). The outcome measures will be completed within 72 hours of admission to the acute ward, and then again prior to discharge from the ward by their treating physiotherapist.

Once the initial outcome measures are completed, participants will be observed across a two-day period (one weekday and one day over the weekend) every 10 minutes from 8am to 5pm. The days of the week will be randomly selected from the six days following completion of consent and functional outcome measures. Participants are not required to interact with the research team during the observation sessions. They will be aware and consent to being observed on two days between 8am and 5pm during their admission to the acute aged care ward, but will not be informed of which actual days the observations will take place.

Intervention code [1]

Not applicable

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

Activity levels as assessed by behaviour mapping using the Work Observation Method by Activity Timing app to record data (location, body position, type of activity and time).

Timepoint [1]

Two randomly selected days during participant's inpatient stay (one weekday and one weekend day).
Observations will be conducted for 1 minute at 10 minute intervals between 8am and 5pm on the two days.

Primary outcome [2]

Mobility as assessed by the Timed Up and Go (TUG) test.

Timepoint [2]

Timepoint 1: around admission onto the acute aged care ward - once informed consent to participate in study obtained.

Timepoint 2: prior to D/C from the acute aged care ward.

Primary outcome [3]

Lower limb function as assessed by the Short Physical Performance Battery (SPPB)

Timepoint [3]

Timepoint 1: around admission onto the acute aged care ward - once informed consent to participate in study obtained.

Timepoint 2: prior to D/C from the acute aged care ward.

Secondary outcome [1]

Care service utilisation on discharge (community care services, residential care services) as determined by review of medical notes.

Timepoint [1]

At discharge from the Prince of Wales Hospital

Eligibility

Key inclusion criteria

- Aged 65 years or older
- Admitted to the Prince of Wales Hospital acute aged care ward due to sustaining a fall
- Walking with or without aid (mobility aid or physical assistance) prior to admission
- Able to provide written informed consent, or have a person responsible that can provide written informed consent on their behalf

Minimum age

65 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

- Expected length of stay on the acute care ward of less than nine days
- Terminally ill or on end of life pathway
- On bed rest
- Transferred or discharged from the acute aged care ward at the POWH prior to completion of at least one day of activity levels observation.

Study design

Purpose

Screening

Duration

Cross-sectional

Selection

Defined population

Timing

Prospective

Statistical methods / analysis

Sample size calculation
Sample size (n=50) was determined using Ausvet’s Epitools sample size calculation for estimating a single mean. An assumed population SD of 18 (based on a previous, similar study), Confidence Interval (CI) of 0.95, and desired precision of 5 were used to determine the study’s target sample size. This is larger than previous research, which had a mean sample size of 35 participants, accommodating for potential attrition during the study.

Analysis plan
Descriptive analyses and regression modelling will be used to quantitatively examine the associations between activity levels and other study variables (sociodemographics, functional ability, mobility status, healthcare services use on discharge, and day of the week). Mean, standard deviation (SD), median, 95% CI, and range of proportion of observations spent in each category, as well as summation of time spent in each category will be calculated. Comparison of activity levels by room size (number of beds) will be analysed using either the independent t-test or Mann-Whitney U test (dependent on data distribution). Comparison of activity levels by day of the week (weekday vs. weekend) will be analysed using either the paired t-test or Wilcoxon paired signed rank test (dependent on data distribution). Statistical significance will be set to p < .05.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

15/02/2021

Actual

22/03/2021

Date of last participant enrolment

Anticipated

30/05/2021

Actual

10/05/2021

Date of last data collection

Anticipated

30/07/2021

Actual

28/05/2021

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Prince of Wales Hospital - Randwick

Recruitment postcode(s) [1]

2031 - Randwick

Funding & Sponsors

Funding source category [1]

University

Name [1]

Macquarie University

Address [1]

Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109

Country [1]

Australia

Primary sponsor type

Individual

Name

Dr Lindsey Brett

Address

Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109

Country

Australia

Secondary sponsor category [1]

None

Name [1]

N/A

Address [1]

N/A

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

South Eastern Sydney Local Health District Human Research Ethics Committee

Ethics committee address [1]

G71 East Wing , Edmund Blacket Building Prince of Wales Hospital Barker Street Randwick NSW 2031

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

08/10/2020

Approval date [1]

22/01/2021

Ethics approval number [1]

2020/ETH02205

Summary

Brief summary

During hospitalisation for an acute illness, an estimated 23% to 33% of older adults experience low mobility. Low levels of activity and older age are predictors of functional deterioration and poor health outcomes during hospitalisation. Yet activity levels of hospitalised older Australians has not been investigated, with previous behaviour mapping research focusing on general rehabilitation and stroke. This project will use behaviour mapping to determine the activity levels of older adults admitted to an acute aged care ward in an Australian hospital due to sustaining a fall, and examine associations between activity levels and health-related variables (e.g. functional ability, community services use, discharge destination). Falls were selected as the condition to focus on among this population as it is one of the most common reasons for admission to hospital among older adults. This project will identify potential and modifiable risk factors that could be addressed to improve patient care and outcomes for older Australians.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Lindsey Brett

Address

Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109

Country

Australia

Phone

+61 2 9850 2487

Fax

lindsey.brett@mq.edu.au

Contact person for public queries

Name

Lindsey Brett

Address

Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109

Country

Australia

Phone

+61 2 9850 2487

Fax

lindsey.brett@mq.edu.au

Contact person for scientific queries

Name

Lindsey Brett

Address

Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109

Country

Australia

Phone

+61 2 9850 2487

Fax

lindsey.brett@mq.edu.au

Data sharing statement

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

No/undecided IPD sharing reason/comment

As per the protocol and consent form no individual participant data will be made available.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
9650	Ethical approval					380887-(Uploaded-03-02-2021-09-52-51)-Study-related document.pdf

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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically