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Trial registered on ANZCTR


Registration number
ACTRN12617001305314
Ethics application status
Approved
Date submitted
30/08/2017
Date registered
12/09/2017
Date last updated
12/09/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
PhyzX 2U: An evaluation of a mobile and cloud based outreach service to improve chronic disease outcomes in underserviced rural communities
Scientific title
PhyzX 2U: An evaluation of a mobile and cloud based outreach service to improve chronic disease outcomes in underserviced rural communities
Secondary ID [1] 292774 0
nil known
Universal Trial Number (UTN)
U1111-1201-4654
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic disease 304567 0
Condition category
Condition code
Cardiovascular 303895 303895 0 0
Hypertension
Diet and Nutrition 303896 303896 0 0
Obesity
Musculoskeletal 303897 303897 0 0
Osteoarthritis
Metabolic and Endocrine 303898 303898 0 0
Diabetes
Musculoskeletal 303899 303899 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take part in a new 12 week mobile health service that uses a combination of face to face consultation, mobile exercise tracking and a health coaching service via telehealth to provide personalised exercise programs to people living with chronic disease in remote rural communities of NSW’s Central West. This health service will be conducted by qualified exercise physiologists and physiotherapists as well as existing undergraduate students on clinical placement. Mobile clinics will be conducted in a range of rural towns at which participants will undergo an initial assessment, duration 1 hour. Telehelath (online video calls) will be used to conduct the health coaching for follow up sessions, duration 30 minutes. Telehealth sessions will be conducted by exercise physiology and physiotherapy students under the supervision of their onsite clinical educator. Frequency of telehealth health coaching sessions will be fortnightly. Track Active, an online exercise prescription platform, utilised by PhyzX 2U which enables program participants to access their exercises via a web browser or an app, and to communicate with PhyzX 2U staff to seek remote support and ask questions will be used. Adherence to the program will be collected from Track Active data. For those participants without internet access, a record of phone calls between recipients and PhyzX 2U staff will be kept and this data will be used to measure their adherence.

Intervention code [1] 299006 0
Rehabilitation
Intervention code [2] 299049 0
Lifestyle
Comparator / control treatment
no control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303237 0
Self reported healthcare use- Self-reported hospitalisations and emergency department use in the past three months.
Timepoint [1] 303237 0
Baseline and 12 week follow up
Primary outcome [2] 303238 0
Exercise self-efficacy (ESEQ)
Timepoint [2] 303238 0
Baseline and 12 week follow up
Primary outcome [3] 303239 0
The Physical Activity Stages of Change Questionnaire (PASOCQ)
Timepoint [3] 303239 0
Baseline and 12 weeks follow up
Secondary outcome [1] 338331 0
Physical activity: Incidental and planned exercise Questionnaire (version WA)
Timepoint [1] 338331 0
Baseline and 12 weeks follow up
Secondary outcome [2] 338332 0
Quality of life: EQ-5D health questionnaire
Timepoint [2] 338332 0
Baseline and 12 weeks follow up
Secondary outcome [3] 338333 0
Feasibility and acceptance of program participants- interview
Feasibility will be measured using both
a. Clients’ uptake of, and adherence to, the PhyzX 2U 12-week intervention, collected by the TrackActive data and qualitative data from the interview
b. Clients’ quality of life (Eq-5D) and physical activity measures (Incidental and planned exercise Questionnaire(version WA)
Timepoint [3] 338333 0
12 week follow up
Secondary outcome [4] 338513 0
Feasibility and acceptance of program from facilitators - interview
Feasibility will be measured by both
a. Staffing costs in providing the service
b. Barriers to the provision of the program collected by qualitative data form the interview
Timepoint [4] 338513 0
12 week follow up
Secondary outcome [5] 338514 0
Participant goals - Goal Attainment Scale
Timepoint [5] 338514 0
baseline and Follow up 12 weeks

Eligibility
Key inclusion criteria
1) Enrolled PhyzX 2U program recipients:
a. With one or more chronic diseases (diabetes, osteoarthritis, obesity, cardiovascular disease, musculoskeletal pain) for 6+ months
b. Are eligible for a general practitioner (GP) management plan and team care arrangement (TCA).
Minimum age
18 Years
Maximum age
65 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Individuals contraindicated to undertake exercise (eg, acutely unwell or deteriorating medical condition such as late stage cancer)
2) Individuals unable to communicate remotely with PhyzX 2U, ie, they do not have a telephone contact number or email/internet access
3) Individuals with a diagnosis of dementia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
na
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
na
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
Statistical methods / analysis
As this is a program evaluation of a newly implemented service, our aim is to sample as broadly and completely as possible. PhyzX 2U currently runs one mobile clinic per month servicing 20 clients per clinic, so our aim is to recruit at least 50% of program recipients per clinic for the study duration. This would provide a conservative estimated total sample size of 80 program recipients with outcome measures. Power calculations indicate that 80 participants will be sufficient to detect a 22% change in goal attainment, assuming 80% power, 5% alpha and 15% drop outs
Descriptive statistics will be used to describe the sample of PhyzX 2U program recipients in terms of age, sex, number and types of chronic conditions they present with. Parametric and non-parametric paired t-tests will be used to compare changes in outcomes from baseline to post intervention to ascertain the impact of the remote health coaching intervention on clients’ goal attainment, quality of life, physical activity levels and self-reported health service use.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 297403 0
University
Name [1] 297403 0
University of Sydney
Address [1] 297403 0
Faculty of Health Sciences
East St
Lidcombe
NSW 2141
Country [1] 297403 0
Australia
Funding source category [2] 297404 0
Commercial sector/Industry
Name [2] 297404 0
PhyzX clinic
Address [2] 297404 0
Orange Arcade,
150 Summer Street,
Orange
NSW 2800
Country [2] 297404 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
Faculty of Health Sciences
East St
Lidcombe
NSW 2141
Country
Australia
Secondary sponsor category [1] 296394 0
Commercial sector/Industry
Name [1] 296394 0
PhyzX
Address [1] 296394 0
Orange Arcade, 150 Summer Street, Orange NSW 2800
Country [1] 296394 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298509 0
University of Sydney
Ethics committee address [1] 298509 0
Level 2 Margaret Telfer Building (K07)
The University of Sydney, NSW 2006
Ethics committee country [1] 298509 0
Australia
Date submitted for ethics approval [1] 298509 0
30/05/2017
Approval date [1] 298509 0
22/08/2017
Ethics approval number [1] 298509 0
2017/484

Summary
Brief summary
Physical activity is an effective intervention for managing many chronic diseases. The majority of the general population are not sufficiently active to meet physical activity guidelines and physical inactivity is more prevalent in people living with chronic disease. People with chronic disease require guidance from healthcare professionals to make lifestyle changes to manage their condition and improve health outcomes, however, there is a lack of healthcare professionals and services available people living in regional and remote NSW. PhyzX 2U is a new mobile service that uses a combination of face to face consultation, mobile exercise tracking and a health coaching service via telehealth to provide exercise programs to people living with chronic disease in remote rural communities of NSW’s Central West.
Objectives: To evaluate the delivery of the PhyzX2U service in its pilot phase. The specific aims are to determine the (i) feasibility, uptake and impact of the PhyzX 2U program in improving health and quality of life for people with chronic disease living in rural and remote communities; and (ii) acceptability of the PhyzX 2U program, including facilitators and barriers to implementation, from the perspectives of the providers and recipients.
Study plan: An observational mixed methods study will be used. Health and goal outcomes from recipients of the PhyzX 2U program will be compared between program initiation and following completion of the 12-week program. Client adherence to the 12-week exercise intervention and PhyzX resources to run the program will also be determined. Semi-structured interviews will be conducted with a subsample of program recipients and program providers to determine the acceptability of the program, and to identify facilitators and barriers to program implementation. Data will be collected between September 2017 and 30 June 2018.
Trial website
na
Trial related presentations / publications
na
Public notes

Contacts
Principal investigator
Name 77302 0
Dr Serene Paul
Address 77302 0
Faculty of Health Sciences, University of Sydney
Rm 228, J Block
75 East Street
Lidcombe
NSW , 2141
Country 77302 0
Australia
Phone 77302 0
+61 2 93519093
Fax 77302 0
Email 77302 0
serene.paul@sydney.edu.au
Contact person for public queries
Name 77303 0
Dr Serene Paul
Address 77303 0
Faculty of Health Sciences, University of Sydney
Rm 228, J Block
75 East Street
Lidcombe
NSW , 2141
Country 77303 0
Australia
Phone 77303 0
+61 2 93519093
Fax 77303 0
Email 77303 0
serene.paul@sydney.edu.au
Contact person for scientific queries
Name 77304 0
Dr Serene Paul
Address 77304 0
Faculty of Health Sciences, University of Sydney
Rm 228, J Block
75 East Street
Lidcombe
NSW , 2141
Country 77304 0
Australia
Phone 77304 0
+61 2 93519093
Fax 77304 0
Email 77304 0
serene.paul@sydney.edu.au

No data has been provided for results reporting
Summary results
Not applicable