Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000521820
Ethics application status
Approved
Date submitted
30/03/2021
Date registered
4/05/2021
Date last updated
4/05/2021
Date data sharing statement initially provided
4/05/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Professional Referral to Physical Activity, Sport and Exercise in older adults and adults with disability - PROPOSE study
Scientific title
The effect of a Telehealth Physiotherapy Physical Activity Advisory Service on Professional Referral to Physical Activity, Sport and Exercise and physical activity levels in older adults and adults with disability - PROPOSE study
Secondary ID [1] 303760 0
Nil known
Universal Trial Number (UTN)
Nil known
Trial acronym
Professional Referral to Physical Activity, Sport and Exercise( PROPOSE)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Physical inactivity 321262 0
Condition category
Condition code
Public Health 319039 319039 0 0
Other public health
Physical Medicine / Rehabilitation 319448 319448 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Trial of Physiotherapy Telehealth Physical Activity Advisory Service (TEPP)

What procedures
1)Assessment by the TEPP physiotherapist to identify the consumer’s current level of physical activity (PA) , level of impairments/medical issues, personal and social strengths, PA preferences and interests
2) Investigation and identification of suitable PA opportunities in the community and liaison with treating health professional
3) Development of a tailored PA plan developed in collaboration with the consumer to improve their PA and participation in community based structured exercise programs that includes goal setting.
4) Health coaching using motivational interviewing -all participants receive between two and six health coaching sessions over 3 months tailored to consumers’ needs and preferences (maximum sessions every 2 weeks for 20-30 minutes ).

What materials
-List of suitable PA opportunities- may include face to face and online options and depending on preferences group and individual options
-A tailored PA plan

Who provided
-Initial assessment, investigation of suitable PA options and liaison with treating health professional conducted by a physiotherapist seconded to the study from Sydney Local Health District (SLHD).
-Health coaching provided by a physiotherapist seconded to the study from SLHD who has clinical experience working with the study population and has completed training courses in health coaching and motivational interviewing through one of the following Wellness Coaching Australia; Health Change Australia and Medicoach as well as receiving skills training provided by other research physiotherapists in IMH in motivational interviewing.

How
-The initial physiotherapy assessment with the consumer will be conducted via telehealth (RPA virtual).
-Investigation of suitable PA options by the TEPP physiotherapist will utilise internet searching, telephone/email discussions and visits with community- based PA providers
-Liaison with treating health professional will be conducted by email or phone by the physiotherapist seconded to the TEPP service
-The information about suitable PA options and the physical activity plan will be developed via telehealth appointments and then emailed/ mailed to participants.
-The health coaching will be delivered via telehealth (RPA virtual).

Where
-The intervention will be delivered via telehealth through RPA virtual to consumers from the target groups (people aged 50+ and adults with a physical disability) attending outpatient/community- based services in Sydney LHD.
-Participating services will include Physiotherapy Departments, Rheumatology Outpatients, Rehabilitation outpatients, Geriatric/Aged Care outpatients and clients of the Health Promotion Service in Sydney LHD.
Health professionals
Health professionals working in these participating outpatient services who are treating clients in the target groups will also be invited to participate in the trial.

When and how much
-The assessment will occur at the beginning of the intervention period and will last for ~ 1 hour delivered by telehealth.
-Investigation of suitable PA options and liaison with the treating health professional will occur after the assessment and may take 5- 7 working days.
-The development of the individual PA plan will occur via a second telehealth appointment lasting for approximately 30-60 minutes.
-The physical activity plan and the PA options will be mailed (or emailed) after the development of the PA plan.
-The initial health coaching will occur via telehealth after the development of the PA plan and will last for 20-30 minutes. Subsequent health coaching sessions will be provided at a tailored frequency and duration (maximum sessions provided approximately every 2 weeks for 20-30 min) for a total duration of 3 months.

Tailoring
The individually-tailored, person-centred approach will work collaboratively with each person to identify their needs, preferences, barriers and strengths impacting on physical activity and will include the development of physical activity recommendations for each individual. The intervention will link participants to existing community programs, with a focus on identifying activities that participants will enjoy and are accessible.

Suitable options may include attendance at a group program, such as those indexed on the Active and Healthy website (https://www.activeandhealthy.nsw.gov.au/), and/or participation in sporting opportunities that cater for people with physical disabilities. Both face to face and online programs can be considered depending on preferences and COVID 19 restrictions.

The number of health coaching sessions beyond the initial two sessions will be tailored to the needs and preferences of the individual consumer with a maximum of 4 additional sessions of 20-30 minutes every two weeks for 3 months.

Strategies to monitor adherence to /fidelity of the intervention will include records of client participation in the essential intervention program components including the assessment session, PA plan development and health coaching sessions. Additional monitoring will include information on number and type of community based PA programs recommended to clients and records of liaison between TEPPS and the treating health professionals as well as community based PA service providers.
Intervention code [1] 320078 0
Lifestyle
Intervention code [2] 320079 0
Behaviour
Intervention code [3] 320383 0
Prevention
Comparator / control treatment
The control group will receive usual care which consists of an information brochure about the NSW Active and Healthy website and the Get Healthy coaching service.
Control group
Active

Outcomes
Primary outcome [1] 326948 0
Physical activity levels ( steps/day measured by an actigraph) of participants in the intervention group compared with participants in the control group.
Timepoint [1] 326948 0
At baseline and 3 months after they commence the study.
Participants will be asked to wear the actigraph for 7 consecutive days at baseline and at three months after the study commences. The actigraph is an activity monitor that can be worn on the waist or wrist. It can measure step count, activity intensity (light, moderate or vigorous), and time spent being active or inactive. The actigraph will be posted to participants with clear instructions for use and telephone support will be available. Participants will also be provided with pre-paid envelopes to return the device and questionnaires to the research centre.
Secondary outcome [1] 393210 0
Self-reported physical activity levels (measured by the Incidental and Planned Exercise Questionnaire (IPEQ)
Timepoint [1] 393210 0
At baseline and 3 months after they commence in the study
Secondary outcome [2] 393212 0
Patient reported outcome measures (PROMIS-29+2 Profile v2.1 (PROPr)
Timepoint [2] 393212 0
At baseline and 3 months after they commence the study
Secondary outcome [3] 393214 0
Types of physical activities (measured by the Incidental and Planned Exercise Questionnaire (IPEQ))
Timepoint [3] 393214 0
At baseline and 3 months after they commence the study
Secondary outcome [4] 393220 0
Implementation outcome
1)The dose of telehealth physiotherapy PA advisory service delivered to participants (implementation outcome).
The dose of the intervention is defined as the intended units of each intervention component delivered to participants by the PA advisory service. The dose will be a composite measure developed from the following data :
- Number of consumers referred to the service (data collection- study records of clients referred to the trial who consent to participate in the study. At randomisation we will collect data on those in control group and those in the intervention group)
- Number of consumers referred to community- based PA opportunities (data collection-audit of service records)
- Number of sessions of community- based PA attended by consumer participants (data collection- study specific follow- up questionnaire plus audit of service records)
- Number of sessions with consumers of the service (data collection- audit of service records)
- Number and type of interventions provided to consumers (data collection -audit of service records)
Timepoint [4] 393220 0
This data will be collected for individual clients at the end of the 3 month trial period.
Secondary outcome [5] 394580 0
Consumer acceptability

Measures will include:
- Consumer engagement with and views about the intervention and whether it is acceptable and useful collected via questionnaires where consumers rate the acceptability of the service using a 5-point Likert scale, Satisfaction and acceptability of the service will also be measured via qualitative interviews conducted using semi-structured interview questions.
Timepoint [5] 394580 0
Three months after commencing participation in the study
Secondary outcome [6] 394581 0
Acceptability and usefulness of the service to health professionals

This will be measured using questionnaires where health professionals use a 5 point likert scale to answer questions about the TEPPS.
Acceptability and usefulness of the TEPPS will also be assessed via qualitative data collected during interviews with health professionals using semi -structured interview questions.

Timepoint [6] 394581 0
Data will be collected from health professionals 6 months after the study has commenced via questionnaires and interviews.
Secondary outcome [7] 394583 0
Costs of the service

Costs involved with setting up and delivering the service will be collected from trial records.
Timepoint [7] 394583 0
Data will be finalised at the end of the intervention period - estimated October/November 2021.

Eligibility
Key inclusion criteria
Consumers aged 50+ and adults with a physical disability attending participating services in Sydney Local Health District (SLHD), including Physiotherapy, Rheumatology, Rehabilitation, Geriatrics/Aged Care and Health Promotion.
Health professionals providing clinical care to the target groups (people aged 50+ and/ or adults with physical disabilities) attending participating services in SLHD as above.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
• Health professionals who are not working in relevant clinical areas with the target groups;
• Consumers who are not from the target groups or receiving care from a participating SLHD outpatient/community based service

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)
Randomisation will use a centralised web-based randomisation system within REDCap (Research Electronic Data Capture) using The University of Sydney licence. This will ensure concealment of allocation to groups and an auditable process.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will use a centralised web-based randomisation system within REDCap (Research Electronic Data Capture) using The University of Sydney licence. This will ensure concealment of allocation to groups and an auditable process. We will utilise permuted block randomisation in this study.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
In this study, statistical models will assess between-group differences in quantitative outcomes at 3-month follow up. Linear regression adjusting for baseline values of outcomes where possible will be used for continuous outcomes and logistic regression will be used for dichotomous outcomes.

We have powered the trial on the primary outcome i.e., steps per day. The trial sample of 200 will enable us to detect an absolute difference between groups of 1000 steps per day, SD 2500 80% power, p=0.05, and a dropout rate of 20%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
31/05/2021
Actual
Date of last participant enrolment
Anticipated
1/11/2021
Actual
Date of last data collection
Anticipated
31/12/2021
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 18995 0
Royal Prince Alfred Hospital - Camperdown
Recruitment hospital [2] 18996 0
Concord Repatriation Hospital - Concord
Recruitment hospital [3] 18997 0
Balmain Hospital - Balmain
Recruitment hospital [4] 18998 0
Canterbury Hospital - Campsie
Recruitment postcode(s) [1] 33535 0
2050 - Camperdown
Recruitment postcode(s) [2] 33536 0
2139 - Concord
Recruitment postcode(s) [3] 33537 0
2041 - Balmain
Recruitment postcode(s) [4] 33538 0
2194 - Campsie

Funding & Sponsors
Funding source category [1] 308168 0
Government body
Name [1] 308168 0
Australian Government Department of Health
Country [1] 308168 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Institute for Musculoskeletal Health
Faculty of medicine and Health
The University of Sydney
Level 10 King George V Building,
Royal Prince Alfred Hospital
Camperdown Sydney NSW 2050
Country
Australia
Secondary sponsor category [1] 308950 0
None
Name [1] 308950 0
None
Address [1] 308950 0
None
Country [1] 308950 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 308153 0
Sydney Local Health District (SLHD)-RPA zone
Ethics committee address [1] 308153 0
Research Ethics and Governance Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 308153 0
Australia
Date submitted for ethics approval [1] 308153 0
Approval date [1] 308153 0
03/03/2021
Ethics approval number [1] 308153 0

Summary
Brief summary
We will undertake an individually randomised controlled trial: effectiveness implementation hybrid type 1 (n=200) to test the impact of a telehealth physiotherapy PA advisory service on physical activity of clients in the target groups.

Implementation outcomes will be assessed alongside effectiveness outcomes and will include dose and implementation determinants.

The PA advisory service will be staffed by a physiotherapist who will provide support to both health professionals and clients in the target groups to promote PA. The PA advisory service will provide a range of services including motivational interviewing, assistance in locating suitable community activities (in-person and on-line), advice on transport and subsidised/low- cost programs, liaison with community providers and where necessary supporting the person to attend these activities. Assistance for health professionals seeking information on these issues will also be available.

Clients in the intervention group will receive services provided by the telehealth physiotherapy PA service. The control group will receive usual care which consists of an information brochure about the NSW Active and Healthy website and the Get Healthy coaching service. Clients in both groups will complete a baseline survey and after 3 months, a follow up survey. The intervention group will also complete an additional survey about their impressions of the intervention at 3 months. Clients will complete actigraph data collection at baseline and 3 month follow up to collect data on PA levels (specifically number of steps/day).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 109718 0
Prof Cathie Sherrington
Address 109718 0
Institute for Musculoskeletal Health
Sydney Local Health District
Level 10N, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box M179, Missenden Road
Camperdown NSW 2050
Country 109718 0
Australia
Phone 109718 0
+61 2 8627 6265
Fax 109718 0
Email 109718 0
[email protected]
Contact person for public queries
Name 109719 0
Ms Kate Purcell
Address 109719 0
Institute for Musculoskeletal Health
Sydney Local Health District
Level 10N, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box M179, Missenden Road
Camperdown NSW 2050
Country 109719 0
Australia
Phone 109719 0
+61 2 8627 6248
Fax 109719 0
Email 109719 0
[email protected]
Contact person for scientific queries
Name 109720 0
Prof Cathie Sherrington
Address 109720 0
Institute for Musculoskeletal Health
Sydney Local Health District
Level 10N, King George V Building, Royal Prince Alfred Hospital (C39)
PO Box M179, Missenden Road
Camperdown NSW 2050
Country 109720 0
Australia
Phone 109720 0
+61 2 8627 6265
Fax 109720 0
Email 109720 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?
Deidentified participant data underlying published results
When will data be available (start and end dates)?
Immediately after publication for 3 years
Available to whom?
Available on a case by case basis at the discretion of the primary sponsor
Available for what types of analyses?
Available for relevant population health related research
How or where can data be obtained?
Available from the principal investigator Prof Cathie Sherrington
Please email the study co-ordinator [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
11138Study protocol  [email protected]



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

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