Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000892617
Ethics application status
Approved
Date submitted
30/07/2014
Date registered
21/08/2014
Date last updated
21/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does feedback on physical activity levels lead to increased physical activity in older people undergoing inpatient rehabilitation?: I-PAct
Scientific title
Does feedback on physical activity levels lead to increased physical activity in older people undergoing inpatient rehabilitation compared to no feedback?
Secondary ID [1] 284688 0
Nil
Universal Trial Number (UTN)
Trial acronym
I-PAct
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical Activity
 292040 0
mobility disorders 292609 0
Condition category
Condition code
Physical Medicine / Rehabilitation 292377 292377 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Regular monitoring and goal setting using feedback on physical activity levels provided via an activity monitor device. Participants in the intervention group will wear a SenseWear armband and the SenseWear display monitor during waking hours (approximately 16 hours per day). The display unit will provide information about the participant's level of activity throughout the day. This information will be used by the physiotherapist and the participant to set individual daily and weekly activity targets. This will be done in the participants usual physiotherapy sessions. Participants in these wards typically recieve physiotherapy once or twice a day on weekdays. Sessions can be delivered on an individual basis or group basis, as is usual practice. Where appropriate, family members are invited to attend physiotherapy sessions if they are able. The length of the physiotherapy sessions will be determined by the treating physiotherapist, as per usual practice, however physiotherapists will be required to record the amount of time spent in physiotherapy sessions. Physiotherapists will educate participants, other staff and their families about the information provided on the display unit, so they can monitor progress towards goals. Techniques such as graphing progress towards activity goals will be used to increase the patient’s motivation and adherence towards achieving these goals. The intervention will cease either when the participant is discharged from rehabilitation or after a period of 3 weeks (which ever occurs first).
Intervention code [1] 289476 0
Rehabilitation
Comparator / control treatment
Participants in the control group will receive standard care, which includes treatment by a multidisciplinary team including physiotherapy. Participants in these wards typically recieve physiotherapy once or twice a day on weekdays. Sessions can be delivered on an individual basis or group basis, as is usual practice. Where appropriate, family members are invited to attend physiotherapy sessions if they are able. The length of the physiotherapy sessions will be determined by the treating physiotherapist, as per usual practice, however physiotherapists will be required to record the amount of time spent in physiotherapy sessions.Participants in the control group will have activity monitored using the SenseWear Armband. They will not be provided with a SenseWear Display Unit, and will not be provided with any feedback on physical activity levels
Control group
Active

Outcomes
Primary outcome [1] 292788 0
Feasibility of delivering intervention
1) Proportion of patients with weekly activity goals (target 100%). Physiotherapists will document weekly goals on a 'goal setting' form. Each participant will have their own goal setting form. When the participant has completed the intervention phase of the study, these forms will be collected.
2) Appropriateness of activity goals, determined by goals being met 80% of the time. Data from the SenseWear activity monitor will be compared with the weekly goal. If the goal is met/ exceeded it will be classified as 'met'. If the goal is not met, it will be classified as 'not met'. A target of 80% has been set based on clinical experience, in that acheiving a goal 100% of the time suggests the goals were not challenging enough.
Timepoint [1] 292788 0
End of intervention phase (maximum 3 weeks)
Secondary outcome [1] 309687 0
Time per day performing activity > 1.5 METs, as determined using the SenseWear armband
Timepoint [1] 309687 0
End of intervention phase (maximum 3 weeks)
Secondary outcome [2] 309688 0
average daily step count, Meausured using the SenseWear Armband
Timepoint [2] 309688 0
End of intervention phase (maximum 3 weeks)
Secondary outcome [3] 309689 0
average daily METS, measured using the SenseWear activity monitor.
Timepoint [3] 309689 0
end of intervention phase (3 weeks)
Secondary outcome [4] 309773 0
clinical utility of activity monitor, measured using via a survey of physiotherapists treating participants in the intervention group and a survey of participants. Both surveys have been sepecifically designed for this study
Timepoint [4] 309773 0
End of intervention phase (max 3 weeks)

Eligibility
Key inclusion criteria
To be eligible for inclusion, participants must:
* Be admitted to Mellor ward (Royal Talbot), ward 11 or 12 (Heidelberg Repatriation Hospital)
* Be aged over 18,
* have as a goal of admission ‘improve upright mobility or improve walking, as determined by either the admission referral or the treating therapist.
* Have an anticipated length of stay greater than one week. People with very short length of stays may not have sufficient time to modify activity based on feedback.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if
* the primary reason for admission is to await placement in residential care or primarily for carer training,
* they have been identified as not requiring physiotherapy on admission,
* there are medical restrictions on mobilization or activity (e.g. non weight bearing).
* The mobility goals are non-weight bearing goals (eg goal is to improve bed mobility/ slide board transfers)
* They are involved in another interventional study
* They have had a lower limb amputation. Upright mobility for this group is often dependent on factors such as wound healing and prosthesis fit.
* Are cognitively impaired or unable to give consent. Part of the intervention involves working with the participant to set and achieve goals. This would be difficult for participants who are cognitively impaired.
* They have an anticipated LOS of less than a week.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients admitted for rehabilitation to either Mellor ward at Royal Talbot Rehabilitation Centre or wards 11 and 12 at the Heidelberg Repatriation Hospital will be eligible for recruitment. Patients admitted to these wards are medically stable, but may have chronic or complex health conditions that require treatment and management by a geriatrician or rehabilitation physician and multidisciplinary team, and require a period of rehabilitation to maximise physical function. A cap of six participants can be in the trial at any one time, as only six armbands are available.

It is not possible to blind either participants or treating therapists to group allocation. Clinical data will be collected by the treating therapists. The activity data will be processed and entered by a research assistant who is blind to group assignment. Dr Blennerhassett and Mr Smith are likely to be unblinded as they will be working closely with clinicians during the intervention phase. Mr Smith may also be treating participants in the trial. Dr Said will remain blinded to group assignment and will be responsible for analysis of data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A blocked stratified randomisation procedure, based on functional level, will be used to allocate participants to either the intervention group, (activity feedback), or a control group (no feedback). Participants will be divided into two categories based on functional level; nonambulant and ambulant. Nonambulant participants include those who are unable to walk, defined as Functional Independence Measure (FIM) Locomotion score 1. Ambulant participants include those who are able to walk with assistance of one person, with supervision only or independently (FIM Locomotion scores 2-7). Randomisation will be computer generated and performed by a third party.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Baseline characteristics will be examined for the intervention and control groups, to determine whether the groups are similar. Time spent in physiotherapy will also be compared between groups, using either paremetric or non parametric statistics as appropriate.
To determine whether participants in the intervention group have weekly activity goals identified using data from the Sensewear, the number of weekly goals identified will be calculated and divided by the total number of intervention weeks.
To determine whether the intervention was delivered as intended, the total number of days for which activity goals were met for the intervention group will be calculated and divided by the total number of intervention days.
Activity data will be examined for normality, and descriptive data calculated for the intervention and control groups using either parametric or nonparametric statistics as appropriate. Effect size will be calculated and sample size will be estimated for the larger study. Note that as the study will not be sufficiently powered, tests for significance will not be conducted.
Feedback from participants and from therapists will be collated and analysed descriptively. Open ended responses will be examined by the research team to identify any common themes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
8/09/2014
Actual
5/02/2015
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
20
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 2513 0
Austin Health - Heidelberg Repatriation Hospital - Heidelberg West
Recruitment hospital [2] 2514 0
Royal Talbot Rehabilitation Centre - Kew
Recruitment postcode(s) [1] 8153 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 8154 0
3101 - Kew

Funding & Sponsors
Funding source category [1] 289310 0
Hospital
Name [1] 289310 0
Austin Medical Research Foundation
Country [1] 289310 0
Australia
Primary sponsor type
Individual
Name
Dr Catherine Said
Address
Austin Health 145 Studley Rd Heidelberg Victoria 3084
Country
Australia
Secondary sponsor category [1] 287980 0
Other
Name [1] 287980 0
Austin Medical Research Foundation
Address [1] 287980 0
Austin Health 145 Studley Rd Heidelberg Victoria 3084
Country [1] 287980 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291426 0
Austin Health Human Research Ethics Committe
Ethics committee address [1] 291426 0
145 Studley Rd
Heidelberg
3084
Vic
Ethics committee country [1] 291426 0
Australia
Date submitted for ethics approval [1] 291426 0
27/05/2014
Approval date [1] 291426 0
06/08/2014
Ethics approval number [1] 291426 0
HREC/14/Austin/254

Summary
Brief summary
The primary purpose of this pilot project is to demonstrate the feasibility of a randomised controlled trial (RCT) investigating whether older people undergoing rehabilitation who receive feedback on activity levels are more active than patients who do not receive feedback.
One of the main reasons older people are admitted for rehabilitation is to improve their mobility. There is increasing evidence indicating that mobility is improved by increasing physical activity. However, studies have shown that physical activity levels are very low in people undergoing rehabilitation. One difficulty for therapists is that to date there has been no way of easily measuring or monitoring activity levels in patients. It is therefore difficult to know how active a person really is, and whether their activity levels are improving during their rehabilitation stay. There are now devices available that can provide accurate feedback about activity levels, even in people who have very low levels of mobility and activity. One device is the SenseWear armband, which is the size of a watch and can measure even small changes in activity. The SenseWear armband has an optional display unit, which provides the person and their therapists with real time feedback about their level of activity.
Studies in community dwelling groups have shown that feedback about activity levels can be used to improve activity. However, older people undergoing rehabilitation are typically more frail and dependent on staff to assist them be active. Hence, it is not known whether providing feedback to older people undergoing rehabilitation will lead to increased activity levels.
Forty older people admitted for inpatient rehabilitation will be randomly allocated to either receive feedback and develop activity goals based on their activity level (intervention group) or monitoring of activity without feedback (control group). All participants will wear a Sensewear device for up to 3 weeks while undertaking inpatient rehabilitation. The results of the pilot will be utilised to inform the design and need for a future RCT. If we find that feedback provided by Sensewear device can promote activity, we shall further investigate if ongoing use can maximise activity level and mobility outcomes and reduce length of stay during inpatient rehabilitation.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 48786 0
Dr Catherine Said
Address 48786 0
Physiotherapy Department
Austin Health
PO Box 5555
Heidelberg , 3084
Victoria
Country 48786 0
Australia
Phone 48786 0
+61394963697
Fax 48786 0
Email 48786 0
[email protected]
Contact person for public queries
Name 48787 0
Dr Catherine Said
Address 48787 0
Physiotherapy Department
Austin Health
PO Box 5555
Heidelberg , 3084
Victoria
Country 48787 0
Australia
Phone 48787 0
+61394963697
Fax 48787 0
Email 48787 0
[email protected]
Contact person for scientific queries
Name 48788 0
Dr Catherine Said
Address 48788 0
Physiotherapy Department
Austin Health
PO Box 5555
Heidelberg , 3084
Victoria
Country 48788 0
Australia
Phone 48788 0
+61394963697
Fax 48788 0
Email 48788 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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