Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000352202
Ethics application status
Approved
Date submitted
1/03/2018
Date registered
8/03/2018
Date last updated
16/04/2019
Date data sharing statement initially provided
16/04/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Active Recovery in Rehabilitation Environments: A descriptive study of patient activity in inpatient rehabilitation units.
Scientific title
Active Recovery in Rehabilitation Environments: A descriptive study of patient activity in inpatient rehabilitation units.
Secondary ID [1] 294201 0
Nil known
Universal Trial Number (UTN)
Trial acronym
ARRE
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
rehabilitation 306836 0
activity levels 306838 0
stroke 306840 0
spinal cord injury 306841 0
orthopaedic condition 306842 0
deconditioning 306843 0
acquired brain injury 306844 0
Condition category
Condition code
Physical Medicine / Rehabilitation 305939 305939 0 0
Other physical medicine / rehabilitation
Public Health 305978 305978 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
Observational study using behavioural mapping (for cognitive, social and physical activity) and accelerometry monitoring (for additional collection of physical activity data in those able to walk).

Data collection (behavioural mapping and accelerometry) will commence 10 +/- 3 days after admission to the rehabilitation unit.

Behavioural Mapping
- The patient activity will be collected using a behaviour mapping technique, where observations of participants in the health care setting are recorded in a standardised manner by a trained researcher. The protocol and checklist for collecting these observations was developed specifically for this study, modified based on AREiSSA protocol (Janssen et al., 2012, 2014a, 2014b), validated for use in rehabilitation settings in those studies.
- Observations of activity will occur every ten minutes. The observation of physical, cognitive, and social activity or no activity will be recorded through use of a mark against relevant categories. The location of the participant, their position (lying, sitting or upright), and any other people present will also be noted.
- A physical activity is defined as any purposeful physical movement – eg all aspects of mobility including transfers or ambulation, and/or participation in activities of daily living such as eating and drinking or getting dressed.
- A cognitive activity is defined as the participant actively engaging in a cognitive task – eg reading/writing/games such as crosswords/participating in a verbal activity such as reading aloud or speech therapy games/listening.
- Social activity is defined as any interaction involving engagement with the participant and other person/s (present or not) – eg talking/non-verbal communication such a laughter
- The category of people present will include: medical, nursing, allied health; other patients; visitors; other hospital staff (eg food services); and alone.
- The location of the participant will be recorded at each observation. Locations will be defined as: bedroom, bathroom, hallway, lounge/dining, outdoor courtyard, therapy, and other off-ward locations (café, library, garden).
- Duration of observation is for each participant is three non-consecutive days of observation from 6am - 8pm.
- Observation days will be a mix of weekday and weekend, as well as aim to observe at different times of the day (early morning and evenings).

Accelerometry monitoring
- Participants that are able to walk (either independent or with assistance) will also be asked to wear an activity monitor (Stepwatch brand) to provide an additional measure of their physical activity. This will record their number of steps/day, and the pattern of activity over their waking hours.
- Duration of accelerometry - Stepwatch monitor worn for all waking hours (taken off for bathing and sleeping) for seven consecutive days during their inpatient stay, with at least one of those days coinciding with behavioural mapping observation.
Intervention code [1] 300489 0
Not applicable
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 304976 0
Description of participant physical activity in each of the rehabilitation units through behavioural mapping checklist (designed specifically for this study)
- proportion (%) of time compared to total observation time (mean/SD)
Timepoint [1] 304976 0
Following 3 days of observation of waking hours (6am to 8pm).
Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.
Primary outcome [2] 305029 0
Description of participant cognitive activity in each of the rehabilitation units through behavioural mapping checklist (designed specifically for this study)
- proportion (%) of time compared to total observation time (mean/SD)
Timepoint [2] 305029 0
Following 3 days of observation of waking hours (6am to 8pm).
Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.
Primary outcome [3] 305030 0
Description of participant social activity in each of the rehabilitation units through behavioural mapping checklist (designed specifically for this study)
- proportion (%) of time compared to total observation time (mean/SD)
Timepoint [3] 305030 0
Following 3 days of observation of waking hours (6am to 8pm).
Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.
Secondary outcome [1] 343778 0
Accelerometry monitor (Stepwatch)
- mean (SD) duration of daily steps in each of the rehabilitation units
This is a primary outcome
Timepoint [1] 343778 0
Measured during waking hours over seven days using the Stepwatch.
Participant data will be included if at least 3 days of data is collected
Secondary outcome [2] 343787 0
Description of participant location throughout the day in each of the rehabilitation units through behavioural mapping checklist (designed specifically for this study)
- proportion (%) of time in each location compared to total observation time (mean/SD)
Timepoint [2] 343787 0
Following 3 days of observation of waking hours (6am to 8pm).
Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.
Secondary outcome [3] 343788 0
Description of who the participant is with (or alone) throughout the day in each of the rehabilitation units through behavioural mapping checklist (designed specifically for this study)
- proportion (%) of time in alone/with others (categories including medical/nursing/allied health/ compared to total observation time (mean/SD)
Timepoint [3] 343788 0
Following 3 days of observation of waking hours (6am to 8pm).
Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.
Secondary outcome [4] 343789 0
Level of independence as measured on the Functional Independence Measure.
Timepoint [4] 343789 0
On admission to the study
Secondary outcome [5] 343792 0
Mood as measured on the Depression Anxiety Stress Scale 21 (DASS21)
Timepoint [5] 343792 0
On admission to the study
Secondary outcome [6] 343793 0
Previous, current and desired activity as measured on the “Everyday Activities – Hospital Questionnaire” (EA-HQ).
Timepoint [6] 343793 0
On admission to the study
Secondary outcome [7] 343794 0
Pattern of type and amount of activity compared with time of day measured through the behavioural mapping checklist (designed specifically for this study)
Timepoint [7] 343794 0
Following 3 days of observation of waking hours (6am to 8pm).
Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.
Secondary outcome [8] 343795 0
Pattern of participant presence in specific locations compared with activity levels measured through the behavioural mapping checklist (designed specifically for this study) and accelerometry monitoring where there is concurrent additional physical activity data collected.
Timepoint [8] 343795 0
Following 3 days of observation of waking hours (6am to 8pm).
Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.
Secondary outcome [9] 343796 0
Pattern of type and amount of activity compared with day of the week (ie weekday vs weekend) measured through the behavioural mapping checklist (designed specifically for this study)
Timepoint [9] 343796 0
Following 3 days of observation of waking hours (6am to 8pm).
Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.
Secondary outcome [10] 343917 0
Accelerometry monitor (Stepwatch)
- mean (SD) duration of distance walked in each of the rehabilitation units
Timepoint [10] 343917 0
Measured during waking hours over seven days using the Stepwatch.
Participant data will be included if at least 3 days of data is collected
Secondary outcome [11] 343918 0
Accelerometry monitor (Stepwatch)
- mean (SD) duration of cadence in each of the rehabilitation units
Timepoint [11] 343918 0
Measured during waking hours over seven days using the Stepwatch.
Participant data will be included if at least 3 days of data is collected
Secondary outcome [12] 343919 0
Accelerometry monitor (Stepwatch)
- mapping bouts of level of physical activity (eg low/high) and trends related to time of day
Timepoint [12] 343919 0
Measured during waking hours over seven days using the Stepwatch.
Participant data will be included if at least 3 days of data is collected
Secondary outcome [13] 344210 0
Description of any activity (physical, cognitive and/or social) in each of the rehabilitation units through behavioural mapping checklist (designed specifically for this study) - proportion (%) of time compared to total observation time (mean/SD). This is a primary outcome.
Timepoint [13] 344210 0
Following 3 days of observation of waking hours (6am to 8pm). Participant data will be included in analysis if they have at least 7 hours of observed time, on at least 2 observations days, recorded.

Eligibility
Key inclusion criteria
This study occurs in two phases - the existing sites and the new site

Existing site inclusion criteria
- Any new patient admitted to the inpatient rehabilitation unit over the data collection phase March - May 2018 (convenience sample)
- any condition requiring rehabilitation
- anticipated length of stay of at least 14 days

New site inclusion criteria
- Equivalent 3 month data collection period
- Defined sample recruited of an approximately equivalent number of participants, selected for general factors (eg condition requiring rehabilitation, disability as per FIM score, age, etc) to the participants from the existing site data set to ensure a similar sample.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
The project aims to recruit at least 15 participants in each of the two data collection phases (existing and new units). This sample size is based on previously published studies collecting activity data in the same manner in inpatient settings (Janssen et al., 2014).

Data analysis
Descriptive statistical analyses using Excel:
- the proportion (%) of time compared to total observation time (mean/SD) will be presented for all categories (eg location, people present, position, and the proportion of time the participant engagement in one or multiple of the categorised activities ie any activity; and physical, cognitive, and/or social) collected during behavioural mapping.
-Aggregated participant data will be reported as mean (SD) duration of daily steps, distance walked and cadence from accelerometry monitoring.
-Participant activity bouts will also be aggregated (mean/SD) to describe any potential trends of low/high physical activity time across the day.
- Pearson’s correlations are planned to explore levels of activity with patient demographic measures collected at admission to the study of: independence (FIM), emotional status (DASS21), and self-reported activity domains (EA-HQ). Given this is a pilot study and only powered as such, we will analyse the trend towards change in these outcomes.
- All outcomes will be compared between each of the two data collection phases (2018 compared with 2019) using a between group comparison calculated as: mean difference (95% confidence interval) for each of the primary and secondary outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
12/03/2018
Actual
9/03/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
25
Final
Recruitment in Australia
Recruitment state(s)
ACT
Recruitment hospital [1] 10238 0
The Canberra Hospital - Garran
Recruitment hospital [2] 10239 0
Calvary Public Hospital ACT - Bruce
Recruitment hospital [3] 13625 0
The University of Canberra Hospital: Specialist Centre for Rehabilitation, Recovery and Research - Bruce
Recruitment postcode(s) [1] 21903 0
2605 - Garran
Recruitment postcode(s) [2] 21904 0
2617 - Bruce
Recruitment postcode(s) [3] 26293 0
2617 - Bruce

Funding & Sponsors
Funding source category [1] 298840 0
Government body
Name [1] 298840 0
Rehabilitation, Aged and Community Care, ACT Health
Country [1] 298840 0
Australia
Primary sponsor type
Individual
Name
Rosalyn Stanton
Address
Rehabilitation, Aged and Community Care, ACT Health
PO Box 11,
WODEN ACT 2606
Country
Australia
Secondary sponsor category [1] 298039 0
None
Name [1] 298039 0
Address [1] 298039 0
Country [1] 298039 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 299782 0
ACT Health Research Ethics and Governance Office Low Risk Sub-Committee
Ethics committee address [1] 299782 0
Ethics committee country [1] 299782 0
Australia
Date submitted for ethics approval [1] 299782 0
17/01/2018
Approval date [1] 299782 0
09/02/2018
Ethics approval number [1] 299782 0
ETHLR.18.023

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

Contacts
Principal investigator
Name 81550 0
Dr Rosalyn Stanton
Address 81550 0
Rehabilitation, Aged and Community Care, ACT Health
PO Box 11,
WODEN ACT 2606
Country 81550 0
Australia
Phone 81550 0
+61 2 61745663
Fax 81550 0
Email 81550 0
[email protected]
Contact person for public queries
Name 81551 0
Rosalyn Stanton
Address 81551 0
Rehabilitation, Aged and Community Care, ACT Health
PO Box 11,
WODEN ACT 2606
Country 81551 0
Australia
Phone 81551 0
+61 2 61745663
Fax 81551 0
Email 81551 0
[email protected]
Contact person for scientific queries
Name 81552 0
Rosalyn Stanton
Address 81552 0
Rehabilitation, Aged and Community Care, ACT Health
PO Box 11,
WODEN ACT 2606
Country 81552 0
Australia
Phone 81552 0
+61 2 61745663
Fax 81552 0
Email 81552 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
No additional documents have been identified.