ANZCTR - Registration

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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]

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

Chronic low back pain

Condition category

Condition code

Musculoskeletal

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]

Lifestyle

Intervention code [2]

Behaviour

Intervention code [3]

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]

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]

The measure will be taken at baseline, 3 months, 6 months (primary end point) and 12 months after randomisation

Secondary outcome [1]

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]