Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001628235p
Ethics application status
Not yet submitted
Date submitted
26/09/2018
Date registered
3/10/2018
Date last updated
11/03/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
CONNECT: Telecare health coaching management of low back pain in primary care to improve disability
Scientific title
CONNECT: Telecare health coaching management of low back pain in primary care to improve disability
Secondary ID [1] 294766 0
Nil known
Universal Trial Number (UTN)
U1111-1221-1245
Trial acronym
CONNECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
sub-acute 307666 0
Chronic low back pain 309866 0
Condition category
Condition code
Musculoskeletal 306732 306732 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention will support the GP in providing optimal conservative management options for patients with non specific LBP. While the GP remains at the centre of the model, there is task shifting where health coaching and symptom monitoring are automated and delegated to a Care manager. The intervention is designed to complement and enhance usual GP care rather than to replace it or to change GP behaviour during their limited patient exposure time. The intervention will be weekly-fortnightly Health Coaching for 16 weeks followed by a maintenance period of 2 months where participants will be contacted twice. There will be four behavioural change components, two mandatory components and two optional components. The mandatory components will be physical activity, including structured and pre-selected exercises, and an online pain coping strategy program. The optional components will be sleep and diet/weight control and will be delegated to an established telephone coaching service for weight management and an online sleep hygiene program. These will be delivered according to the goals and preferences of the participant and will be identified in the initial interview with the care manager.

Intervention description:
The care managers who will deliver the health coaching intervention will be registered allied health professionals trained in health coaching and recommended LBP management. The initial assessment for the Health coaching intervention will be delivered face-to-face in the Kolling Institute on the Royal North Shore Hospital campus. Subsequent health coaching consultations with the care manager will be delivered remotely by telephone or video conference on mobile devices or a computer using the Physitrack App/online program.

The health coaching will involve discussion with the participant to identify their current health status (with regard to their LBP) compared to where they realistically would like their health status to be. The care manager will ascertain with the participant their readiness to change and their confidence to change and help the participant to set SMART goals. Barriers that may prevent goal achievement will be identified and in collaboration with the participant ways in which to overcome these barriers will be explored. The care manager may incorporate motivational interviewing strategies where indicated and direct the participant to evidence based LBP information uploaded on the physitrack program or to recommended online programs such as painHEALTH.

The initial health coaching session will take up to an hour and subsequent sessions are expected to last between 10 and 20 minutes. The initial intensive phase will last for 4 months with the session frequency varying depending on participant preference. Weekly sessions will be encouraged for the first 3 weeks followed by sessions every 2-3 weeks. During the intervention the care manager will also be monitoring symptoms via ‘Physitrack’. This program enables the participant to document their activity and exercise, along with any pain associated with each on a daily basis. If ‘Physitrack’ identifies any reduction in their ability to participate or increases in pain, it will automatically send an alert to the care manager. If the care manager receives an alert, they will contact the participant to discuss their management and assist in trying to resolve any issues prior to the next scheduled consult. During the ‘intensive phase’ the care manager will provide ongoing encouragement, advice and support for self-management and help participants meet their core goals. They will continue to work through any barriers with the participant and tailor the individual program as required.

The intensive phase will be followed by a 2 month maintenance phase where the participant will be encouraged to self-manage their symptoms and activity levels. During this time the participant will only have one scheduled consult to monitor their progress and help address any issues, unless alerted by ‘Physitrack’.

Mandatory components:
1. Physical activity and specific exercises: This will involve a specific exercise program comprising of up to 4 exercises that will be developed with the care manager to target back-specific strength, flexibility and endurance to facilitate the physical goal identified by the participant. This component will be delivered via Physitrack. A physical activity plan designed to increase the general physical activity levels of the participant will also be incorporated (e.g. a walking program for a designated time). The physical activity and specific exercises will be set in collaboration with each individual participant and demonstrated by the care manager using videoconferencing on Physitrack. The app will then enable the participant to follow the exercises by video and written text, document compliance and pain levels experienced with each activity or exercise. The App also provides a forum for the patient to contact their care manager if experiencing any problem.
2. Pain coping skills training. This will involve one of the free online training programs: Examples - ACI pain management network program comprising of 7 educational videos each lasting between 5 and 12 minutes to be viewed at the individuals own pace. This program includes an introduction to chronic pain and information on how to develop skills and strategies to manage pain.
-painHEALTH the free online resource supported by the Western Australian Government. It provides evidence based information on specific conditions (including LBP), pain and coping strategies for both consumer and health professional. Each module is presented in both written and video format. This resource will be used in conjunction with the care manager. The specific modules used will be indicated by the participants needs as identified during the health coaching consultations

Optional components:
1. Sleep hygiene. Participants that identify issues with sleep will be directed to free online educational resources aimed to address the individual sleep issues the participant describes. The participant will also be referred to 2 online sleep coaching programs (SLEEPIO or SHUTi) that they can participate in if specific sleep coaching is preferred.
2.Weight loss and maintenance. The NSW Get Healthy program for weight loss will be used for participant identifying weight loss and nutrition as a goal. This is a remotely delivered health coaching program involving 10 phone calls over a 6-month period.
If a participant choses to access this program, they will only be contacted by their care manager monthly so as not to present the participant with 2 similar program concurrently

Ongoing liaison with the care manager:
The care manager will use personalised support via phone call, Physitrack for video call or SMS messages. This is a 2-way system that allows the participant to ask questions between scheduled contacts via email or SMS. Contact will be scheduled in advance and invitations and reminders to attend will be send through Physitrack. Symptom monitoring will be done via Physitrack and will include changes in pain, function and physical activity participation. When the participant fails to reach their improvement goal or shows signs of symptom deterioration, the case manager will be automatically flagged and will contact the participant for change in management and feedback.
Intervention code [1] 301065 0
Lifestyle
Intervention code [2] 312555 0
Behaviour
Intervention code [3] 312556 0
Treatment: Other
Comparator / control treatment
Participants randomised to usual care will receive any management strategy deemed appropriate for the individual by their treating GP. They will be contacted at 3, 6 and 12 months for the completion of outcome measure surveys. They will receive a single page of general information on low back pain specifically designed for this study that will contain information based on the current evidence based recommendations for the management of sub-acute and chronic low back pain
Control group
Active

Outcomes
Primary outcome [1] 305786 0
Patient Specific Functional Scale
This is a condition-specific measure used to quantify activity limitation and function in patients with musculoskeletal pain. The participant will be asked to identify three important activities that they are unable to do or are having difficulty with as a result of their LBP. They will rate each activity using a numerical rating scale of 0-10 (0 meaning unable to perform activity and 10 meaning able to perform activity to the same level as before the injury or/problem). This will take approximately 2 minutes to complete.
This is a validated measure that has not been specifically designed for the study.
Timepoint [1] 305786 0
The measure will be taken at baseline, 3 months, 6 months (primary end point) and 12 months after randomisation
Secondary outcome [1] 352004 0
Average pain
This will be a self-reported measure using a single question to rate the participant’s average pain of the preceding 7 days. It uses an 11 point numerical rating scale 0-10 (0 meaning no pain and 10 meaning worst pain possible) and relies on the patient’s memory of the actual pain severity experienced. It is considered to be responsive to change, easy to understand and complete and will take less than a minute to complete.
Timepoint [1] 352004 0
The measure will be taken at baseline, 3 months, 6 months and 12 months after randomisation
Secondary outcome [2] 352005 0
Pain self-efficacy questionnaire
Timepoint [2] 352005 0
The measure will be taken at baseline, 3 months, 6 months and 12 months after randomisation
Secondary outcome [3] 352006 0
Willingness to undergo surgery.

This is a measure to identify how willing a participant would be to undergo surgery as a treatment option if offered. There are 3 response options: ‘unwilling, unsure, and willing.’ This measure will take less than a minute to complete and is based on the study by Gandhi et al 2013 'Predictors of willingness to undergo elective musculoskeletal surgery' Patient Prefer Adherence, 2013. 7: p. 191-7
Timepoint [3] 352006 0
The measure will be taken at baseline, 3 months, 6 months and 12 months after randomisation
Secondary outcome [4] 352007 0
Depression, anxiety and stress scale (DASS-21)
Timepoint [4] 352007 0
The measure will be taken at baseline, 3 months, 6 months and 12 months after randomisation
Secondary outcome [5] 352008 0
Quality of life – AoL 4D
Timepoint [5] 352008 0
The measure will be taken at baseline, 3 months, 6 months and 12 months after randomisation
Secondary outcome [6] 352009 0
Patient global perceived
Physical activity (Active Australia Questionnaire
Timepoint [6] 352009 0
The measure will be taken at baseline, 3 months, 6 months and 12 months after randomisation
Secondary outcome [7] 352010 0
Health care utilisation (via MBS/PBS and diary)
Timepoint [7] 352010 0
The measure will be taken at baseline, 3 months, 6 months and 12 months after randomisation

Eligibility
Key inclusion criteria
Participants will be included if they:
• Are older than 18 years of age
• Have a diagnosis of NSLBP
• Present with symptoms for at least 6 weeks duration
• Consent for details to be passed to trial co-ordinator
• Basic smart phone/tablet device or computer literacy
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants will be excluded if they have:
• Known or suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases, widespread neurological disorder, radiculopathy).
• A diagnosis of specific low back pain, i.e. sciatica, spinal stenosis.
• Back surgery within the previous 2 years.
• Co-morbid health conditions that would prevent active participation in the physical activity programs (e.g. unstable angina, uncontrolled hypertension).
• Inadequate English to participate in behavioural interviewing or complete outcome measures.
• Any disorder that may reduce capacity to understand and follow simple instructions

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)
Central randomisation by phone/fax/computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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 power of this study will be calculated following after the pilot study to test the feasibility and study procedures has been completed.
The primary outcome will be average pain at the 6-month follow-up. Data will be analysed by an experienced biostatistician who will be blinded to group status. Primary analyses will be by intention-to-treat. Statistical significance will be defined as P<0.05 on the basis of a two-sided test. Primary analyses be adjusted for baseline scores. A secondary analysis including data from all follow-ups and both procedures and taking into account repeated measurement will be conducted using generalized estimating equations. The coefficient of the group x time interactions will provide estimates of treatment effects over time. The remaining outcome measures will also be regarded as secondary and analysed separately with log-binomial regression for dichotomous measures and linear regression analysis for continuous outcomes. In the case of non-compliance with treatments before the 6 and 12-month visits, per protocol analyses will be performed. Heterogeneity between recruiting GP's will be assessed and adjusted for in sensitivity analyses by including pharmacy/area as a covariate in the models. Sensitivity analyses will also be conducted to adjust for main outcome predictors (e.g. symptom severity, age).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/02/2019
Actual
Date of last participant enrolment
Anticipated
4/03/2019
Actual
Date of last data collection
Anticipated
1/06/2020
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 299370 0
Self funded/Unfunded
Name [1] 299370 0
Not yet secured
Country [1] 299370 0
Primary sponsor type
University
Name
University of Sydney
Address
Institute of Bone and Joint Research,
Level 10, The Kolling Institute,
Royal North Shore Hospital,
Reserve Road
St Leonards, NSW 2065,
Australia
Country
Australia
Secondary sponsor category [1] 298649 0
None
Name [1] 298649 0
Address [1] 298649 0
Country [1] 298649 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 300275 0
The University of Sydney Human Research Ethics Committee
Ethics committee address [1] 300275 0
Research Integrity & Ethics Administration
THE UNIVERSITY OF SYDNEY
Level 2 Margaret Telfer Building (K07)
The University of Sydney
NSW
2006
Ethics committee country [1] 300275 0
Australia
Date submitted for ethics approval [1] 300275 0
07/01/2019
Approval date [1] 300275 0
Ethics approval number [1] 300275 0

Summary
Brief summary
The aim of the study is to examine the effect of a telecare health coaching intervention on function in people with subacute and chronic low back pain.

We hypothesise that the addition of health coaching to GP usual care will be more effective in improving function than usual GP care alone.

The intervention will involve health coaching directed towards 4 core components: (2 Mandatory components) Physical activity and specific exercises; pain coping strategies; (2 Optional components) weight management; and sleep hygeine.

There will be a 4 month intensive phase with regular health coaching sessions followed by a 2 month maintenance phase involving a minimum of 1 session. Exercise and physical activity pain symptoms as well as adherence will be completed online by the participant and if pain levels rise or adherence reduces the care manager will be automatically alerted to make contact with the participant.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 83122 0
A/Prof Manuela Ferreira
Address 83122 0
Institute of Bone and Joint Research,
The Kolling Institute and Department of Rheumatology,
University of Sydney,
Royal North Shore Hospital,
Reserve Road,
St Leonards
NSW 2065,
Country 83122 0
Australia
Phone 83122 0
+61 2 9463 1897
Fax 83122 0
Email 83122 0
[email protected]
Contact person for public queries
Name 83123 0
Ms Joanna Prior
Address 83123 0
Institute of Bone and Joint Research,
The Kolling Institute and Department of Rheumatology,
University of Sydney,
Royal North Shore Hospital,
Reserve Road,
St Leonards
NSW 2065,
Country 83123 0
Australia
Phone 83123 0
+61 2 9463 1889
Fax 83123 0
Email 83123 0
[email protected]
Contact person for scientific queries
Name 83124 0
A/Prof Manuela Ferreira
Address 83124 0
Institute of Bone and Joint Research,
The Kolling Institute and Department of Rheumatology,
University of Sydney,
Royal North Shore Hospital,
Reserve Road,
St Leonards
NSW 2065,
Country 83124 0
Australia
Phone 83124 0
+61 2 9463 1897
Fax 83124 0
Email 83124 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

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