Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000734864
Ethics application status
Approved
Date submitted
29/04/2021
Date registered
10/06/2021
Date last updated
13/05/2022
Date data sharing statement initially provided
10/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Examining the cost-effectiveness, acceptability, and efficacy of telehealth physiotherapy on mobility in older people receiving aged care services
Scientific title
The TOP UP Trial - Examining the effect of a physiotherapy-led telehealth and exercise intervention on mobility in older people receiving aged care services: an effectiveness and implementation randomised controlled trial.
Secondary ID [1] 303822 0
nil known
Universal Trial Number (UTN)
Trial acronym
Telehealth Physiotherapy for Older People (TOP UP) Trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mobility 321340 0
Falls 321341 0
Condition category
Condition code
Physical Medicine / Rehabilitation 319119 319119 0 0
Physiotherapy
Injuries and Accidents 319120 319120 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1: Participants allocated to the telehealth physiotherapy group will be offered 10 video-conferencing sessions with a physiotherapist over 6-months via zoom using a mobile tablet device. Participants will use their own mobile tablet device such as an iPad or will be provided one by the research team.

Participants will have an exercise program designed by a physiotherapist and will be asked to exercise for 4 times per week, 20 -30 minutes per session, up to 2 hours per week over 6 months. Participant's will be given a home exercise program booklet that has been specifically designed for this study as well as access to the trial's website to follow prescribed on-line exercise programs designed by physiotherapists to assist them to achieve the prescribed exercise dosage. Dosages will be individually prescribed to challenge the participants to work at a moderate level of intensity and will be assessed via the Borg CR10 scale. Each participant will aim to achieve 2–3 sets of 10–15 repetitions of each exercise. Dosages will be gradually adjusted as participants’ abilities change throughout the course of the program.

Exercise content will contain a mix of balance and lower limb strengthening exercises based on the Otago Exercise Program. The program will be tailored to participant ability and progression of difficulty for the exercise program will occur as skills and confidence increase. Intervention adherence will be recorded by participants and/or their carers in exercise diaries.

Strengthening exercises will include seated knee extension, standing knee flexion, standing hip abduction and extension, and squats. Strengthening exercises will be upgraded by adding ankle weights.

Balance exercises will include a combination of heel and toe raises, stepping in different directions, single-leg standing, and sit-to-stand practice. Balance exercises will be upgraded by: 1) reducing hand support and/or 2) narrowing the base of support.

Participants will be supported to access their physiotherapy telehealth sessions and follow their exercise programs by the care staff of the participant's aged care service provider (TOP UP coaches).
Intervention code [1] 320126 0
Rehabilitation
Intervention code [2] 320127 0
Prevention
Comparator / control treatment
Arm 2: Participant's allocated to the waitlist control group will continue with their normal daily routines. These participants will continue with usual care regarding their usual exercise, physiotherapy, mobility, and pain management programs. These participants will be offered a similar intervention after the 6-month intervention. This will consist of 4 zoom teleconferencing sessions over 8 weeks.
Control group
Active

Outcomes
Primary outcome [1] 327007 0
The primary effectiveness outcome is mobility assessed with the Short Performance Physical Battery (SPPB).
Timepoint [1] 327007 0
6-month period after randomisation
Secondary outcome [1] 393432 0
Number of falls in the 6 months after randomisation, assessed using monthly falls calendars
Timepoint [1] 393432 0
6-month period after randomisation
Secondary outcome [2] 393433 0
5 times sit to stand as a measure of lower limb strength and balance.
Timepoint [2] 393433 0
Baseline and 6-month period after randomisation
Secondary outcome [3] 393434 0
Quality of Life will be measured by the The EQ-5D-5L at baseline and 6 months. It comprises of 5 items and participants will be able to rate their level of impairment across dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and global health rating on a visual analogue scale (EQ-VAS). The EQ-5D-5L was found to be a highly reliable and valid measure of the quality of life in older people with mild to moderate dementia.
Timepoint [3] 393434 0
Baseline and 6-month period after randomisation
Secondary outcome [4] 393435 0
Goal attainment measured with the Goal Attainment Scale
Timepoint [4] 393435 0
Baseline and 6-month period after randomisation
Secondary outcome [5] 396699 0
Acceptability of the intervention in the intervention group only as assessed by a study-specific survey.
Timepoint [5] 396699 0
6-months post randomisation

Eligibility
Key inclusion criteria
Eligible participants will:
a) Age: 65 + years
b) Living in the community or in residential aged care facilities receiving Commonwealth funded aged care services
c) Able to walk 10 m +/- walking aid
d) Have internet connectivity to access mobile device/tablet
e) Life expectancy > 6 months and sufficient sensory, neurological , cognitive, and English language skills for exercise and video-based interventions
f) Participants will need to be assessed by their aged care provider as having normal or mild cognitive impairment by one of the following cognitive assessments: attain a score of 18 or more on the Mini State Mental Examination (MMSE), or 20 or more on the Rowland Universal Dementia Assessment Scale (RUDAS), or 10 or less on the Psychogeriatric Assessment Scales Cognitive Impairment Scale (PAS-Cog) or 4 or more on the Memory Impairment Scale (MIS)
g) Obtain participant consent or from their person responsible if the participant has mild cognitive impairment
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The trial will exclude adults who:
a) are expected to live for less than 6 months
b) Having participated in a similar physiotherapy program in the last 12 months
c) Having physical, sensory, mental health or behavioural issues that would prevent participation in the intervention as identified by our aged care partners
d) People who are unable to cooperate with an intervention program. Cognitive impairment per se is not an exclusion criterion but older people with moderately severe dementia assessed by a score of 17 or less on the MMSE, a score of 19 or less on the RUDAS, a score more than 10 on the PAS-Cog, or a score of 20 or less on the Modified Telephone Interview Cognitive Status may not be able to participate.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Group allocation will be determined using REDCap (Research Electronic Data Capture), a centralised web-based randomisation system within the Sydney Local Health District. This will ensure concealment of allocation to groups and an auditable process. Randomisation will occur after participants have completed all baseline measures to avoid recruitment bias.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation schedule will be created by a researcher not involved in recruitment/eligibility assessment using Stata software (StataCorp) and embedded in the study REDCap database. Allocation to either the intervention group or the control group will be stratified according to the home care or the residential aged care setting.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size of 240 participants will provide 80% power to detect a substantial change of a 0.9 point between-group difference in 12-point SBBP scores at 6 months (assuming SD of 2.8, p =0.05 and 20% dropouts).
A quantitative data analysis using Stata statistical software will use linear models for continuously scored primary and secondary outcomes to compare intervention to control with baseline scores as a covariate. Negative binomial regression will compare fall rates between groups over the 6-month study period. Analyses will follow a pre-specified Statistical Analysis Plan, will be conducted while masked to group allocation and will use an intention-to-treat approach. Analyses will utilise Stata software and will be overseen by an experienced biostatistician.
A trial-based economic evaluation will be performed using the mean costs and the mean health outcomes in each trial arm, the incremental cost per 1) additional person avoiding mobility deterioration, 2) additional fall prevented, 3) additional person with an improvement in quality of life in the intervention group compared with control group will be calculated. Bootstrapping will estimate a distribution around costs and health outcomes and calculate the confidence intervals around the incremental cost-effectiveness ratios. The results will be plotted on the cost-effectiveness plane, and as cost-effectiveness acceptability curves.
A mixed methods quantitative and qualitative approach will be used to analyse the implementation outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/08/2021
Actual
1/08/2021
Date of last participant enrolment
Anticipated
30/12/2022
Actual
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
240
Accrual to date
53
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC

Funding & Sponsors
Funding source category [1] 308219 0
Government body
Name [1] 308219 0
National Health and Medical Research Council
Country [1] 308219 0
Australia
Funding source category [2] 311428 0
Charities/Societies/Foundations
Name [2] 311428 0
Dementia Australia
Country [2] 311428 0
Australia
Primary sponsor type
Hospital
Name
Concord Repatriation General Hospital
Address
Concord Repatriation General Hospital
Hospital Road, Concord, NSW, 2139.
Country
Australia
Secondary sponsor category [1] 309004 0
None
Name [1] 309004 0
Address [1] 309004 0
Country [1] 309004 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308201 0
Sydney Local Health District Human Research Ethics Committee – Concord Repatriation General Hospital
Ethics committee address [1] 308201 0
Ethics committee country [1] 308201 0
Australia
Date submitted for ethics approval [1] 308201 0
28/02/2021
Approval date [1] 308201 0
28/05/2021
Ethics approval number [1] 308201 0
CH62/6/2021-009

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

Contacts
Principal investigator
Name 109906 0
Mr Rik Dawson
Address 109906 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd, Camperdown, NSW 2050
Country 109906 0
Australia
Phone 109906 0
+61 2 8627 6265
Fax 109906 0
Email 109906 0
[email protected]
Contact person for public queries
Name 109907 0
Rik Dawson
Address 109907 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd, Camperdown, NSW 2050
Country 109907 0
Australia
Phone 109907 0
+61 2 8627 6265
Fax 109907 0
Email 109907 0
[email protected]
Contact person for scientific queries
Name 109908 0
Rik Dawson
Address 109908 0
Institute for Musculoskeletal Health, School of Public Health, The University of Sydney, PO Box M179 Missenden Rd, Camperdown, NSW 2050
Country 109908 0
Australia
Phone 109908 0
+61 2 8627 6265
Fax 109908 0
Email 109908 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant de-identified data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Data will be available on a case-by-case basis at the discretion of the Principal Chief Investigator
Available for what types of analyses?
For meta-analysis
How or where can data be obtained?
Access subject to approvals by Principal Chief Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11204Study protocol  [email protected]
11205Statistical analysis plan  [email protected]
11206Ethical approval  [email protected]
11207Informed consent form  [email protected]



Results publications and other study-related documents

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

Documents added automatically
SourceTitleYear of PublicationDOI
EmbasePhysiotherapy-led telehealth and exercise intervention to improve mobility in older people receiving aged care services (TOP UP): Protocol for a randomised controlled type 1 hybrid effectiveness-implementation trial.2023https://dx.doi.org/10.1136/bmjnph-2022-000606
N.B. These documents automatically identified may not have been verified by the study sponsor.