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Trial registered on ANZCTR


Registration number
ACTRN12616001518459
Ethics application status
Approved
Date submitted
20/08/2016
Date registered
3/11/2016
Date last updated
3/11/2016
Type of registration
Prospectively registered

Titles & IDs
Public title
Observing activity levels within an Acute Stroke and Sub-Acute Inpatient Rehabilitation Unit pre and post transition to a new hospital
Scientific title
Does the physical hospital environment have an impact on activity levels in patients recovering within an Acute Stroke and Sub-Acute Inpatient Rehabilitation Unit.
Secondary ID [1] 289966 0
nil known
Universal Trial Number (UTN)
U1111-1186-6284
Trial acronym
MONACT (monitoring activity)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 299963 0
orthopedic fractures 299964 0
de-conditioning 299965 0
Condition category
Condition code
Stroke 300521 300521 0 0
Haemorrhagic
Stroke 300522 300522 0 0
Ischaemic
Injuries and Accidents 300523 300523 0 0
Fractures

Intervention/exposure
Study type
Observational
Patient registry
True
Target follow-up duration
3
Target follow-up type
Days
Description of intervention(s) / exposure
SETTING:

Observation Period II:
The second observation period will be recorded at the Sunshine Coast University Hospital Acute Stroke Unit and Inpatient Rehabilitation units. Participants will receive the normal standard care and treatment of an Acute Stroke Unit and Sub-Acute Rehabilitation Unit. It will take place over the same length as the first observation period 2017 November, December and January 2018. Each participant will be observed from one Thursday until the Sunday of that week, a four day period.

Sunshine Coast University Hospital Acute Stroke Unit:
Bed configuration – open beds (16 x single, 2 x double)
Floor space /patient (once access is granted to the site floor space sqm will be calculated and will open with 20 patients)
Common areas
Therapy spaces ( one gym area located on ward level)
Outdoor access (via lifts to ground level)
Walking distances (bed to- toilet / gym / common area /outdoors

Sunshine Coast University Hospital Acute Rehabilitation unit:
Bed configuration – open beds (20 x single, 14 x double)
Floor space /patient (once access is granted to the site floor space sqm will be calculated and will open with 30 patients)
Common areas (2 lounge and 2 dining rooms)
Therapy spaces (one large gym with an outdoor mobility garden, one OT gym, one multi-purpose gym, two large assessment rooms)
Outdoor access (at the ward level a outdoor mobility garden and sitting area near the therapy gyms and doors from the 2 lounge and 2 dining rooms lead to a large sitting area)
Walking distances (will be calculated once we have access to the site)
Intervention code [1] 295655 0
Not applicable
Comparator / control treatment
Observation Period I:
The first observation period will occur at the current acute stroke unit in Nambour General Hospital and in the Caloundra Rehabilitation and Assessment Unit (RAU). Participants will receive standard care and treatment of an Acute Stroke Unit and Sub-Acute Inpatient Rehabilitation Unit. It will take place over the same length as the first observation period 2016 November, December and January 2017. Each participant will be observed from one Thursday until the Sunday of that week, a four day period.
ASU:
Acute Stroke Unit at Nambour General Hospital
Bed configuration – total beds (8 x single, 4 x double)
Floor space /patient (55.2 sqm and 16 patients )
Common areas (Reception Seating area 6.6sqm, Elevator Seating Area 11.7sqm, Corridor gym seating area 6.4sqm)
Therapy spaces ( Therapy Gym floor space 30 sqm)
Outdoor access (no access at level, distance from elevators to front of hospital is 114m, to courtyard level 87m, to outdoor undercover area is 42m)
Walking distances (bed to ensuite 2.7m -single and 5.6m -double / Pod A (room 1-6) 12.1m and Pod C (room 11-16) 45.4m mean distance to gym / common area /outdoors)
RAU:
Rehabilitation and Assessment Unit at Caloundra Hospital
Bed configuration – total beds (5 x single, 4 x double, 2 x 3 bed and 2 x 4 bed bays)
Floor space /patient ( m2 and 24 patients )
Common areas (one dining room with TV, lounge with TV/audio and puzzles, recreational room with puzzles, fuzzball and painting materials)
Therapy spaces (The physiotherapy gym is located an average of 71 meters from rooms on the east wing and 103 meters from rooms on the west. The room is 98 square meters and should not be used when no staff member is in this room. The occupational therapy gym is located an average of 65 meters from rooms on the east wing and 93 meters from rooms on the west wing. The room is 60 square meters and should not be used when no staff member is in this room. The Speech therapy room is located an average of 61 meters from rooms on the east wing and 93 meters from rooms on the west wing. The room is 9 square meters and should not be used when no staff member is in this room)
Outdoor access (wheelchair ramp access 22m from ward doorway to main undercover BBQ area it is located an average of 46 meters from rooms on the east wing and 40 meters from rooms on the west wing, in front of hospital is located a sitting area an average of 78 meters from rooms on the east wing and 115 meters from rooms on the west wing, outside room 5/6 located 8m from those rooms, outdoor area close to occupational therapy room is located an average of 65 meters from rooms on the east wing and 93 meters from rooms on the west wing).
Walking distances (bed to- toilet distance for rooms on the east wing is 6m and west wing 4m /The physiotherapy gym is located an average of 71 meters from rooms on the east wing and 103 meters from rooms on the west. The occupational therapy gym is located an average of 65 meters from rooms on the east wing and 93 meters from rooms on the west wing. The speech therapy room is located an average of 61 meters from rooms on the east wing and 93 meters from rooms on the west wing/ The Dining room is located an average of 53 meters from rooms on the east wing and 23 meters from rooms on the west wing/ The TV lounge room is located an average of 20 meters from rooms on the east wing and 24 meters from rooms on the west wing/ The recreational room is located an average of 20 meters from rooms on the east wing and 47 meters from rooms on the west wing)
Control group
Active

Outcomes
Primary outcome [1] 299332 0
Determine if the physical hospital environment has an impact on total, physical activity levels using behavioral mapping and accelerometers in patients recovering in one acute stroke unit (ASU) and one sub-acute rehabilitation unit (RAU) pre and post transition to a newly built hospital ward
Timepoint [1] 299332 0
Activity monitoring data and Behavioral mapping data will the analysed following the first and then again the second observational period. The first observational period will occur from November 2016 until February 2017. The second observational period will occur from November 2017 until February 2018.
Primary outcome [2] 299333 0
Determine if the physical hospital environment has an impact on total cognitive activity levels using behavioral mapping and accelerometers in patients recovering in one acute stroke unit (ASU) and one sub-acute rehabilitation unit (RAU) pre and post transition to a newly built hospital ward
Timepoint [2] 299333 0
Activity monitoring data and Behavioral mapping data will the analysed following the first and then again the second observational period. The first observational period will occur from November 2016 until February 2017. The second observational period will occur from November 2017 until February 2018.
Primary outcome [3] 300055 0
Determine if the physical hospital environment has an impact on total social activity levels using behavioral mapping and accelerometers in patients recovering in one acute stroke unit (ASU) and one sub-acute rehabilitation unit (RAU) pre and post transition to a newly built hospital ward
Timepoint [3] 300055 0
Activity monitoring data and Behavioral mapping data will the analysed following the first and then again the second observational period. The first observational period will occur from November 2016 until February 2017. The second observational period will occur from November 2017 until February 2018.
Secondary outcome [1] 326864 0
Quantify body position, patient location and people present with the patient using behavioral mapping in patients recovering in one acute stroke unit (ASU) and one sub-acute rehabilitation unit (RAU) pre and post transition to a newly built hospital ward
Timepoint [1] 326864 0
Using Behavioral mapping we will determine body position, patient location and people present following the first and then again after the second observational period. The first observational period will occur from November 2016 until February 2017. The second observational period will occur from November 2017 until February 2018.
Secondary outcome [2] 328623 0
Determine baseline data for patient activity levels within the Sunshine Coast University Hospitals Acute Stroke and inpatient Rehabilitation Units
Timepoint [2] 328623 0
Using behavioral mapping and activity monitoring during the second observational period November 2017 until February 2018 base line data for patient activity (physical/social/cognitive) will be determined baseline activity levels within the Sunshine Coast University Hospital.
Secondary outcome [3] 328926 0
To compare the role of different methods of measuring physical activity and location: behavioral mapping and accelerometer in inpatient ward environments
Timepoint [3] 328926 0
Activity monitoring data and Behavioral mapping data will the analysed following the first and then again the second observational period. The first observational period will occur from November 2016 until February 2017. The second observational period will occur from November 2017 until February 2018. This will allow us to compare the activity levels recorded by Behavioral mapping and Activity monitoring techniques.

Eligibility
Key inclusion criteria
Participants in the ASU:
- The patient is admitted to the Acute Stroke Unit with the diagnosis of a stroke and enrollment to the study will occur within 7 days after stroke onset.
- Patient is an adult > 18 years.
- Patients have an expected stay of more than 2 days.
- The patient is fit for rehabilitation. The patient requires assistance for basic ADL’s at the time of recruitment.
- The patient is not deteriorating in the 24 hours before recruitment.
- The patient or their substitute decision maker is able to provide written informed consent.

Pre morbid status for ASU:
- The patient was walking independently.

Participants in the Rehabilitation Unit:
- The patient is admitted with one of the following AN-SNAP codes; Stroke 3-204, 3-206, 3-208, 3-209; Orthopaedic fractures 3-227, 3-228, 3-229, and Re-conditioning 3-242, 3-243 and 3-244.
- Patient enrollment will occur within 7 days of admission to the rehab unit
- Patient is an adult > 18 years and older.
- The patient or their substitute decision maker is able to provide written informed consent.
- Patients are in the Rehabilitation Assessment Unit (RAU) during their admission or Acute Inpatient Rehabilitation ward at the Sunshine Coast University Hospital.
- Patients expected length of stay is of no less than 14 days on admission to the inpatient rehabilitation unit

Pre morbid status for Rehabilitation Unit:
- The patient was walking independently.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants in the Acute Stroke Unit
- with an extensive psychiatric history and who are unable to participate in rehabilitation due to current active medical condition/s

Participants in the Rehabilitation Unit
- with an extensive psychiatric history and who are unable to participate in rehabilitation due to current active medical condition/s

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
For the primary outcome we will use one-way ANCOVA to determine difference in activity levels between groups adjusting for covariates of age in all participants and stroke severity (NIHSS) in stroke patients only. We will determine the difference in activity levels for ‘total activity’ and for the physical, social and cognitive activity domains. We will also determine total percentage time spent in different postural positions, location and people present with the participant. Consistent with previous research in this field, missing and unobserved data will be excluded from the statistical analysis for the primary outcome (Janssen, H., et al., An enriched environment increases activity in stroke patients undergoing rehabilitation in a mixed rehabilitation unit: a pilot non-randomized controlled trial. Disabil Rehabil, 2014. 36(3): p. 255-62)

We will analyze percentage observed total, physical, social and cognitive activity shown in participants occupying single, two or multiple bedrooms while present in their hospital room pre and post transition. We will also determine percentage observed total, physical, social and cognitive activity shown in communal and outdoor areas pre and post transition.

Activity data from the accelerometer will be analyzed using the proprietary software or established algorithms for identifying outcome measures implemented in custom written software. This will consist of loading the raw data into the software and extracting the steps per day (Stepwatch) or arm movements (Actigraph), along with the duration of intervals per day in which no steps or arm movements are recorded. These data will then be averaged across the three days to obtain the average score per day for that patient.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/11/2016
Actual
Date of last participant enrolment
Anticipated
1/02/2018
Actual
Date of last data collection
Anticipated
4/02/2018
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 6501 0
Nambour General Hospital - Nambour
Recruitment hospital [2] 6502 0
Caloundra Hospital - Caloundra
Recruitment postcode(s) [1] 14065 0
4560 - Nambour
Recruitment postcode(s) [2] 14066 0
4551 - Caloundra

Funding & Sponsors
Funding source category [1] 294339 0
Government body
Name [1] 294339 0
Transition and Transformation Strategic Research Funding, Sunshine Coast Hospital and Health Service
Country [1] 294339 0
Australia
Primary sponsor type
Individual
Name
isaac tonello
Address
Malney Soildiers and Memorial Hospital
19 bean Street
Maleny 4552 QLD
Country
Australia
Secondary sponsor category [1] 293178 0
University
Name [1] 293178 0
university of the sunshine coast
Address [1] 293178 0
University of the Sunshine Coast
School of Sport and Exercise Science,
90 Sippy Downs Road,
Sippy Downs 4556
Queensland
Country [1] 293178 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295771 0
The Prince Charles Hospital Human Research Ethics Committee
Ethics committee address [1] 295771 0
Ethics committee country [1] 295771 0
Australia
Date submitted for ethics approval [1] 295771 0
26/05/2016
Approval date [1] 295771 0
11/08/2016
Ethics approval number [1] 295771 0
HREC/16/QPCH/150

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 1038 1038 0 0
/AnzctrAttachments/371327-MONACT Research Protocol version 1.0.docx (Protocol)
Attachments [2] 1039 1039 0 0
/AnzctrAttachments/371327-MASTER PICF MONACT Rehabilitation Participant version 2.0 with FINAL.doc (Participant information/consent)
Attachments [3] 1040 1040 0 0
/AnzctrAttachments/371327-MASTER PICF MONACT Substitute Decision Maker version 2.0 FINAL.doc (Participant information/consent)
Attachments [4] 1041 1041 0 0
/AnzctrAttachments/371327-Ethics approval MONACT 11.08.16.pdf (Ethics approval)

Contacts
Principal investigator
Name 68366 0
Mr Isaac Tonello
Address 68366 0
Maleny Soldiers and Memorial Hospital
19 Bean Street
Maleny QLD 4552
Country 68366 0
Australia
Phone 68366 0
+61754205056
Fax 68366 0
+61754205001
Email 68366 0
isaac.tonello@health.qld.gov.au
Contact person for public queries
Name 68367 0
Isaac Tonello
Address 68367 0
Maleny Soldiers and Memorial Hospital
19 Bean Street
Maleny QLD 4552
Country 68367 0
Australia
Phone 68367 0
+61754205056
Fax 68367 0
+61754205001
Email 68367 0
isaac.tonello@health.qld.gov.au
Contact person for scientific queries
Name 68368 0
Isaac Tonello
Address 68368 0
Maleny Soldiers and Memorial Hospital
19 Bean Street
Maleny QLD 4552
Country 68368 0
Australia
Phone 68368 0
+61754205056
Fax 68368 0
+61754205001
Email 68368 0
isaac.tonello@health.qld.gov.au

No information has been provided regarding IPD availability


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No Supporting Document Provided



Results publications and other study-related documents

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