Trial Review

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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] 302720 0
None
Universal Trial Number (UTN)
U1111-1260-8693
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
falls 320570 0
gerontology 320571 0
Condition category
Condition code
Public Health 317577 317577 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
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] 318999 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 325618 0
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] 325618 0
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] 325619 0
Mobility as assessed by the Timed Up and Go (TUG) test.
Timepoint [2] 325619 0
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] 325620 0
Lower limb function as assessed by the Short Physical Performance Battery (SPPB)
Timepoint [3] 325620 0
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] 388591 0
Care service utilisation on discharge (community care services, residential care services) as determined by review of medical notes.
Timepoint [1] 388591 0
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?
No
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
20
Accrual to date
Final
26
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 17966 0
Prince of Wales Hospital - Randwick
Recruitment postcode(s) [1] 31840 0
2031 - Randwick

Funding & Sponsors
Funding source category [1] 307148 0
University
Name [1] 307148 0
Macquarie University
Country [1] 307148 0
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] 307736 0
None
Name [1] 307736 0
N/A
Address [1] 307736 0
N/A
Country [1] 307736 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307261 0
South Eastern Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 307261 0
Ethics committee country [1] 307261 0
Australia
Date submitted for ethics approval [1] 307261 0
08/10/2020
Approval date [1] 307261 0
22/01/2021
Ethics approval number [1] 307261 0
2020/ETH02205

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

Contacts
Principal investigator
Name 106606 0
Dr Lindsey Brett
Address 106606 0
Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109
Country 106606 0
Australia
Phone 106606 0
+61 2 9850 2487
Fax 106606 0
Email 106606 0
[email protected]
Contact person for public queries
Name 106607 0
Lindsey Brett
Address 106607 0
Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109
Country 106607 0
Australia
Phone 106607 0
+61 2 9850 2487
Fax 106607 0
Email 106607 0
[email protected]
Contact person for scientific queries
Name 106608 0
Lindsey Brett
Address 106608 0
Department of Health Professions,
Faculty of Medicine and Health Sciences,
Macquarie University,
Ground floor, 75 Talavera Road,
Macquarie University,
NSW 2109
Country 106608 0
Australia
Phone 106608 0
+61 2 9850 2487
Fax 106608 0
Email 106608 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
As per the protocol and consent form no individual participant data will be made available.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
9650Ethical 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.