Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618000774224
Ethics application status
Approved
Date submitted
15/01/2018
Date registered
8/05/2018
Date last updated
8/05/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Maintaining physical activity of people living at home with advanced disease
Scientific title
A sit-to-stand intervention to maintain functional capacity of palliative care recipients in the community
Secondary ID [1] 292281 0
None
Universal Trial Number (UTN)
U1111-1199-6650
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cancer 304118 0
COPD 304119 0
Neurodegenerative diseases 304120 0
advanced or end stage disease
 306458 0
Condition category
Condition code
Cancer 303448 303448 0 0
Any cancer
Respiratory 303449 303449 0 0
Chronic obstructive pulmonary disease
Neurological 303450 303450 0 0
Neurodegenerative diseases
Physical Medicine / Rehabilitation 303451 303451 0 0
Occupational therapy
Physical Medicine / Rehabilitation 303452 303452 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Training sessions: Initial training will occur at baseline and be delivered by a trained occupational or physiotherapist. Both Arm 1 (Intervention) and Arm 2 (Control) will receive a low back chair with arms and education on the safest and most effective way to complete a sit-to-stand transfer from a chair at baseline. All participants will be shown how to access to the Physitrack app on the iPad and its video demonstration of correct procedures for completing a sit-to-stand transfer.
Arm 1 (Intervention) will be taught the intervention at baseline.
Mode of administration: individual face-to-face session in the patient’s home
Frequency and duration: Arm 1 will be asked to complete 5 repetitions of 5x Sit-to-Stand at ~ 2 hourly intervals or as able each day for 6 weeks.
Research assistants who deliver the intervention at baseline will be either an occupational therapist or physiotherapist depending on recruitment. They will be trained in methods for assessing baseline and completion measures to ensure consistency (Weeks 1 and 6).
An Allied Health Assistant trained in the study protocol will visit at Weeks 2-5 to monitor transfer status, apply or remove an activity monitor and prompt participants to self-report function and wellbeing via an iPad. Intervention adherence will be monitored by the activity monitor and the Allied Health Assistant who will remind participants to complete self-reports at their weekly visit.
Intervention code [1] 298669 0
Rehabilitation
Comparator / control treatment
Baseline measures for the control group will be the same as for the intervention group. They will receive the same low back chair with arms with seat height set at ~ 46-48 cms. Participants will also be taught the safest and most efficient method to complete a STS transfer by an OT or PT. They will be able to access a video application (Physitrack) on their iPad that will remind them of the correct way to complete a transfer if they choose. Videos of their transfer ability will be taken via the iPad at baseline and completion. The activPAL will be applied at baseline and worn for 1 week. An Allied Health Assistant will visit at the end of weeks 2-5 to review transfer techniques for safety. They will remove the activPAL at week 2 and 4 and reapply at weeks 3 and 5.
patients will self report functional status measure (AKPS) and palliative care specific capability related quality of life measure (ICECAP-SCM) via an iPad.
Participants will be assessed at week 6 by a trained occupational therapist (OT) or physiotherapist (PT) who will collect final outcome measures as noted above. The control group will receive reminders via the calendar function on the iPad to complete their weekly self report measures. However, they will NOT be asked to complete the 5x Sit-To-Stand five times a day.
Control group
Active

Outcomes
Primary outcome [1] 303814 0
Functional status as measured by the Australian Karnofsky performance Status scale (AKPS), self reported on iPad
Timepoint [1] 303814 0
Baseline and at weeks 2,3,4 and 5 after intervention commencement and at 6 weeks [Primary timepoint]
Primary outcome [2] 305532 0
Transfer ability (i.e. sit-to-stand) as measured by the 5xSTS.
Timepoint [2] 305532 0
Timepoint: at baseline and at 6 weeks at intervention completion.
Secondary outcome [1] 340214 0
QOL or wellbeing when receiving palliative and supportive care as measured by the ICECAP-SCM, self reported on iPad
Timepoint [1] 340214 0
Timepoint: at Baseline and at weeks 2,3,4 and 5 after intervention commencement and at 6 weeks (Completion).
Secondary outcome [2] 345637 0
Video of sit-to-stand transfer to measure transfer characteristics not captured by the 5xSTS. These include but are not limited to positioning of hands, feet, and trunk, stability while transferring, speed of transfer.
Timepoint [2] 345637 0
Timepoint: Baseline (week 1) and completion (week 6)
Secondary outcome [3] 345784 0
Time spent lying measured by the activPAL accelerometer.
Timepoint [3] 345784 0
Timepoint: at weeks 2 and 4 after intervention commencement and at 6 weeks (Completion).
Secondary outcome [4] 345894 0
Time spent sitting measured by the activPAL accelerometer.
Timepoint [4] 345894 0
Timepoint: at weeks 2 and 4 after intervention commencement and at 6 weeks (Completion).
Secondary outcome [5] 345895 0
Time spent mobilising measured by the activPAL accelerometer.
Timepoint [5] 345895 0
Timepoint: at weeks 2 and 4 after intervention commencement and at 6 weeks (Completion).
Secondary outcome [6] 346399 0
Number of of sit-to-stand transitions measured by the activPAL accelerometer.
Timepoint [6] 346399 0
Timepoint: at weeks 2 and 4 after intervention commencement and at 6 weeks (Completion).
Secondary outcome [7] 346400 0
Participant acceptability: a purposive sample of participants from the intervention and control groups will be invited to participate in semi-structured interviews in their home. interviews will explore participant perspectives about the feasibility and acceptability of self reporting and the role of STS in everyday activities, The intervention group participant's interviews will also include questions about the intervention feasibility and acceptability.
Timepoint [7] 346400 0
Within 1 month of completion

Eligibility
Key inclusion criteria
AKPS score of 60-70 at commencement
Resource Utilisation Group - Activities of Daily Living (RUG-ADL) transfer score of 1
(i.e. requires no physical assistance to complete a sit-to-stand transfer)
Montreal Cognitive Assessment (MoCA) score of greater than or equal to 18 (i.e mild or no cognitive impairment)
Participants will be community palliative care clients and will be reasonably familiar with or willing to use an iPad
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
AKPS: 50 or below, 80 and above

RUG-ADL: transfer score between 3-5

MoCA score of equal to or less than 17.

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)
A person external to the study will generate the randomisation sequence and place the allocations in sealed opaque envelopes. The envelopes will be given to the Palliative Care research nurses who are consenting participants. The study nurses will allocate consented participants to intervention or control groups as per envelope contents.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation: Sequence generation will be created using a computer software (Excel and Random function) to create a random order of participants for each study arm.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Descriptive statistics will be calculated for baseline variables. In order to test our hypothesis that completion of STS repetitions will lead to an improvement in function, we will compare incidental activity (number of STS’s aside from repetitions and number of steps) between groups. In the intervention group we expect to see (i) a decrease in time taken to complete the 5xSTS or (ii) the ability to complete a 5xSTS by study completion if unable to complete at entry. We expect no change in with 5xSTS capacity in the control group over the same time period. Secondary analyses will compare AKPS and RUG-ADL scores related to STS capability and/or incidental activity as measured by activPAL. Structured analysis of videorecorded STS performance pre and post intervention will also be completed.
Feasibility criteria: Recruitment of 5 participants per month with ongoing monitoring of retention rates, participant ability to complete the intervention, use and complete self- report tools according to study protocols and adherence to wearing of the activPAL.
Qualitative analysis will be inductive and thematic, employing invivo and process coding. A one page summary of interview transcripts will be made available to participants in order to confirm it accurately represents their comments and to provide them with the opportunity to delete any comments or add additional ones. Member checking serves to strengthen trustworthiness of qualitative data and will be a valuable addition to study findings about feasibility and acceptability

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/05/2018
Actual
Date of last participant enrolment
Anticipated
20/08/2018
Actual
Date of last data collection
Anticipated
27/09/2018
Actual
Sample size
Target
24
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 9772 0
Southern Adelaide Palliative Services - Bedford Park
Recruitment postcode(s) [1] 18550 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 296823 0
Charities/Societies/Foundations
Name [1] 296823 0
Flinders Foundation
Country [1] 296823 0
Australia
Primary sponsor type
University
Name
Flinders University, College of Nursing and Health Sciences
Address
Flinders University
Sturt Rd
Bedford Park
South Australia 5042
Country
Australia
Secondary sponsor category [1] 296913 0
None
Name [1] 296913 0
Address [1] 296913 0
Country [1] 296913 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298058 0
SAC HREC
Ethics committee address [1] 298058 0
Ethics committee country [1] 298058 0
Australia
Date submitted for ethics approval [1] 298058 0
15/05/2017
Approval date [1] 298058 0
25/10/2017
Ethics approval number [1] 298058 0
95.17

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

Contacts
Principal investigator
Name 75850 0
Dr Deidre Morgan
Address 75850 0
Palliative and Supportive Services
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 75850 0
Australia
Phone 75850 0
+61872218220
Fax 75850 0
NA
Email 75850 0
[email protected]
Contact person for public queries
Name 75851 0
Deidre Morgan
Address 75851 0
Palliative and Supportive Services
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 75851 0
Australia
Phone 75851 0
+61872218220
Fax 75851 0
NA
Email 75851 0
[email protected]
Contact person for scientific queries
Name 75852 0
Deidre Morgan
Address 75852 0
Palliative and Supportive Services
College of Nursing and Health Sciences
Flinders University
GPO Box 2100
Adelaide SA 5001
Country 75852 0
Australia
Phone 75852 0
+61872218220
Fax 75852 0
NA
Email 75852 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

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.