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Trial registered on ANZCTR


Registration number
ACTRN12620000889954
Ethics application status
Approved
Date submitted
7/07/2020
Date registered
10/09/2020
Date last updated
10/09/2020
Date data sharing statement initially provided
10/09/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparison of a discharge system and usual care, for supporting people after completing hospital physiotherapy treatment for chronic low back pain: a randomised controlled trial
Scientific title
A randomised controlled trial investigating the effectiveness, cost-effectiveness, and scalability of a coordinated discharge system linking NSW public hospitals and NSW Health, involving the Get Healthy Coaching Service®, in people with chronic low back pain.
Secondary ID [1] 301712 0
GNT1180474
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic low back pain 318165 0
Condition category
Condition code
Musculoskeletal 316182 316182 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The project will involve a randomised, clinical, single-blind, parallel, superiority study with 1:1 allocation ratio to either a discharge support system (incorporating referral to the Get Healthy Service® health coaching intervention) or usual care control group. The total sample will include 368 participants.

Discharge support system (Intervention group):
Participants in the intervention group will be enrolled into a discharge support system that incorporates referral to the Get Healthy Service. The Get Healthy Service is a free, well-establish service funded and managed by the NSW Ministry of Health that delivers telephone-based health coaching programs. Participants will be offered up to 10 health coaching sessions, delivered over 6 months, from the standard Get Active coaching module. Up to a maximum total of 10 sessions, the participant will decide on the frequency of the telephone-based health coaching sessions. Up to a maximum total of 10 sessions, the participant will also decide on the number of sessions they wish to attend. The health coaching sessions will be delivered by university-qualified health care professionals (e.g. exercise physiologists, dietitians) who have undergone training procedures to comply with the standards of NSW Health.

During the health coaching sessions, health coaches will motivate and support participants to remain physically active and sustainably achieve personal health-related goals. For example, this may include the provision or revision of a tailored exercise plan, recommendations for local community opportunities to increase physical activity participation (e.g. local recreational centers or community exercise programs), or a personalised diet plan, depending on the participant's goals. In accordance with Get Healthy Service®'s standard operations, each session will be up to 17 minutes in duration. Adherence will be monitored by the number of health coaching sessions attended, recorded by the Get Healthy Service®.
In accordance with the current specifications of the Get Healthy Service® coaching program, after completing their program of health coaching sessions, participants will be given the option to: (1) ‘graduate’ from the health coaching program, (2) re-enrol for further health coaching sessions, or (3) opt-in to a free SMS program for a further 6 months called the Get Active Stay Active SMS program.

For participants who opt-in for the Get Active Stay Active SMS program, they will receive automatic, standardised motivational SMS reminders tailored towards 3 distinct goal categories: (1) physical activity, (2) diet or (3) weight maintenance. A health coach will first phone the participant to confirm their preference for 1-2 goal categories. The health coach will also establish the participant’s preference for the frequency of receiving SMS reminders (i.e. specific day(s) and time(s) of the week), and the number of SMS reminders they wish to receive per goal category. There will be no minimum frequency for receiving SMS reminders (i.e. the frequency of receiving SMS reminders will be decided entirely by the participant). An example of a motivational SMS reminder is: Hi {Participant Name}, remember your goal to {Goal} this week. Long term change takes time, but you can get there by moving forward one step at a time. {GHSH_Coach}.” At 3 months after joining the Get Healthy Stay Healthy SMS program, the health coach will phone the participant to monitor their progress and adjust goals or SMS reminder preferences as needed. At 6 months after joining the Get Healthy Stay Healthy SMS program, the health coach will phone the participant to confirm completion (‘graduation’) from the SMS program, and encourage participants to continue ongoing self-maintenance of positive health behaviours.
Intervention code [1] 318013 0
Treatment: Other
Intervention code [2] 318014 0
Lifestyle
Intervention code [3] 318015 0
Behaviour
Comparator / control treatment
Standard usual care (Control group):
The control group will receive the standard usual care that is prescribed at discharge from conservative one-to-one physiotherapy treatment for chronic low back pain at the Musculoskeletal Outpatient Physiotherapy Departments at Western Sydney Local Health District Hospitals. Commonly, this involves the prescription of advice, education and a home-exercise program with no further intentional follow-up with the participant. Participants may be referred to a non-specific exercise groups or community exercise groups at the discretion of the physiotherapist.
Control group
Active

Outcomes
Primary outcome [1] 324362 0
Rate of using hospital, medical and health services for low back pain (composite measure), assessed by data linkage to medical records, MBS and PBS data, and self-reported questionnaires specifically designed for this study.
Timepoint [1] 324362 0
Baseline, fortnightly, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline) (primary timepoint).
Secondary outcome [1] 384438 0
Self-reported physical activity levels assessed with the Global Physical Activity Questionnaire
Timepoint [1] 384438 0
Baseline, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [2] 384439 0
Objective physical activity levels, assessed using an Axivity tri-axial accelerometer worn for 7 consecutive days
Timepoint [2] 384439 0
Baseline, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [3] 384440 0
Function, assessed with the Patient Specific Functional Scale
Timepoint [3] 384440 0
Baseline, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [4] 384441 0
Pain intensity of low back pain, assessed with the Numerical Rating Scale
Timepoint [4] 384441 0
Baseline, fortnightly, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [5] 384442 0
Functional disability, assessed with the Roland–Morris Disability Questionnaire
Timepoint [5] 384442 0
Baseline, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [6] 384443 0
Quality of life, assessed with the Assessment of Quality of Life questionnaire
Timepoint [6] 384443 0
Baseline, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [7] 384444 0
Self-reported use of self-management behaviours, assessed with a specifically designed questionnaire
Timepoint [7] 384444 0
Baseline, fortnightly, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [8] 384445 0
Sleep quality, assessed with the Pittsburgh Sleep Quality Index
Timepoint [8] 384445 0
Baseline, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [9] 384446 0
Attitudes regarding use of pain medications, assessed with the short-form Pain Medication Attitudes Questionnaire
Timepoint [9] 384446 0
Baseline, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)
Secondary outcome [10] 384447 0
Beliefs about back pain, assessed with the Back Beliefs Questionnaire
Timepoint [10] 384447 0
Baseline, immediately post-intervention (e.g. 6 months from baseline), 6 months post-intervention (e.g. 12 months from baseline)

Eligibility
Key inclusion criteria
To be included, participants will need to meet all the following inclusion criteria:
- be 18 years of age or older;
- present with a diagnosis of non-specific LBP of at least 12-week duration, with or without leg pain but without radicular (e.g. reflex changes, motor loss) symptoms; Non-specific LBP will be diagnosed after screening for serious spinal pathology and indicators of potentially serious conditions using ‘red’ flags;
- have been recently discharged (<2 weeks post-treatment) from physiotherapy treatment from outpatient physiotherapy departments at the participating hospital sites;
- have adequate hearing and eyesight, and independent ambulatory status.
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Potential participants will be excluded if they have any of the following:
- known or suspected serious spinal pathology (fracture, inflammatory disorder);
- diagnosis of specific LBP, e.g. sciatica, spinal stenosis (grade 3 to 4);
- co-morbid health condition(s) preventing participation in physical activity or exercise programs (i.e. heart or vascular conditions), as diagnosed by a medical practitioner;
- fibromyalgia or systemic/inflammatory condition
- currently pregnant or planning to become pregnant over the study duration;
- inadequate English to complete outcome measures or participate in the health coaching intervention;
- spinal surgery in the past 12 months;
- have LBP caused by involvement in a road traffic accident in the last 12 months or ongoing litigation.

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 researcher, not involved in treatment or assessment procedures, will centrally randomise all eligible participants, via a computer software program (Research Electronic Data Capture project, hosted by the University of Sydney), to either:
1. Discharge support system (intervention group):
2. Standard usual care (Control group)
Participants will be notified of their allocation via phone call from an unblinded research team member.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Since participants will be notified of their allocation at or after discharge from treatment, with minimal potential for treatment contamination, randomisation will be at participant level. Randomisation will be by random permuted blocks of 6.
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

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
Recruitment hospital [1] 17031 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 30700 0
2145 - Westmead

Funding & Sponsors
Funding source category [1] 306149 0
Government body
Name [1] 306149 0
National Health and Medical Research Council
Address [1] 306149 0
16 Marcus Clarke St, Canberra ACT 2601
Country [1] 306149 0
Australia
Funding source category [2] 306151 0
Government body
Name [2] 306151 0
Western Sydney Local Health District
Address [2] 306151 0
Westmead Hospital, Darcy Road, Westmead NSW 2145
Country [2] 306151 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
The University of Sydney, NSW 2006, Australia

Country
Australia
Secondary sponsor category [1] 306620 0
None
Name [1] 306620 0
Address [1] 306620 0
Country [1] 306620 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306367 0
Western Sydney Local Health District Human Research Ethics Committee
Ethics committee address [1] 306367 0
Westmead Hospital, Darcy Road, Westmead NSW 2145
Ethics committee country [1] 306367 0
Australia
Date submitted for ethics approval [1] 306367 0
17/01/2020
Approval date [1] 306367 0
13/08/2020
Ethics approval number [1] 306367 0
2020/ETH00115

Summary
Brief summary
Many people improve following discharge from conservative hospital treatment for low back pain (LBP), however some experience worsening LBP and seek additional care. The lack of support for patients after treatment discharge has been identified as a key driver for this clinical pattern. Introducing a discharge support system, incorporating referral to the NSW Health Get Healthy Service®, which delivers telephone-based health coaching programs, has strong potential to bridge this clinical gap. Health coaching can improve physical activity levels in people with LBP. We will conduct a randomised controlled trial investigating the effectiveness and cost-effectiveness of a discharge support system, compared to usual care, for improving pain, disability, and physical activity levels, and to investigate the effect on the future use of hospital, medical and health services for LBP, in people recently discharged from hospital outpatient physiotherapy treatment for chronic LBP. In-depth interviews will be conducted to identify factors contributing to intervention success, which will be used to inform the development of an implementation plan for upscaling the discharge support system across NSW LHDs.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103630 0
Prof Paulo Ferreira
Address 103630 0
Room 6217, Floor 6, Charles Perkins Centre, Johns Hopkins Dr, Camperdown, The University of Sydney, NSW 2006
Country 103630 0
Australia
Phone 103630 0
+61 2 8627 7062
Fax 103630 0
+61 2 9351 9601
Email 103630 0
paulo.ferreira@sydney.edu.au
Contact person for public queries
Name 103631 0
Prof Paulo Ferreira
Address 103631 0
Room 6217, Floor 6, Charles Perkins Centre, Johns Hopkins Dr, Camperdown, The University of Sydney, NSW 2006
Country 103631 0
Australia
Phone 103631 0
+61 2 8627 7062
Fax 103631 0
+61 2 9351 9601
Email 103631 0
paulo.ferreira@sydney.edu.au
Contact person for scientific queries
Name 103632 0
Prof Paulo Ferreira
Address 103632 0
Room 6217, Floor 6, Charles Perkins Centre, Johns Hopkins Dr, Camperdown, The University of Sydney, NSW 2006
Country 103632 0
Australia
Phone 103632 0
+61 2 8627 7062
Fax 103632 0
+61 2 9351 9601
Email 103632 0
paulo.ferreira@sydney.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
No other documents available
Summary results
No Results