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Trial registered on ANZCTR


Registration number
ACTRN12615000189527
Ethics application status
Approved
Date submitted
4/02/2015
Date registered
26/02/2015
Date last updated
15/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Integrating Mobile-health and Physical Activity to reduce the burden of Chronic low back pain Trial
Scientific title
Does a patient-centered physical activity intervention involving the use of mobile-health and health coaching compared to a standard of care (advice) reduce pain level, disability and care seeking in individuals with chronic low back pain?
Secondary ID [1] 286089 0
Nil known
Universal Trial Number (UTN)
U1111-1166-7730
Trial acronym
IMPACT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic low back pain 294091 0
Condition category
Condition code
Musculoskeletal 294399 294399 0 0
Other muscular and skeletal disorders
Physical Medicine / Rehabilitation 294415 294415 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention group will receive an individually tailored lifestyle modification plan through the care of an experienced physiotherapist and trainned health coach over a six-month period. The intervention will involve one single face-to-face health coaching session and fortnightly telephone counseling sessions during 6 months. The face-to-face session will occuor approximately 8 days after the recruitment. The session will take place at the participant's home and should take no longer than 1 hour. After this face-to-face session, the only contact that the Health Coach will have with the participant will be by phone, every two weeks. The phone calls should take no longer than 30 minutes.
The focus of the lifestyle modification will be on a gradual patient-centred increase in physical activity where patients are encouraged to devise goals fortnightly to suit and advance their lifestyle. This intervention will be supported by the use of mobile-health which will include a specifically designed mobile WebApp and physical activity monitoring device (FitBit).
The mobile WebApp will be built and customized specifically for the purposes of this project using available technology and concept currently implemented by Spare Intelligence Engine Registered Trademark. The main purpose of the application is to allow participants to record symptoms, monitor their activity and contact their health coach. Participants will be able to access the application at any time and receive feedback on their physical activity goals. Feedback messages constructed by the health coach are personalized and matched to participants’ needs by tailoring them to their response.
The activity monitoring device will be provided to the participant by the health coach who will also demonstrate its use. Each participant will receive a brief orientation covering this instrument’s proper functions. Telephone support will be offered to participants who have difficulties with the device setup. The Fitbit is a physical activity tracker designed to help individuals to become more active and sleep better. This device logs a range of data about each participant’s activity, providing feedback on the number of steps taken in each 24-hour period as well as the distance walked; calories burned and sleep duration and quality. The feedback on the present day is available on the device itself and the steps taken per day, week, and month will be also summarized graphically on the device’s website (www.fitbit.com) or a Smartphone, which will also be demonstrated to the participant. The participants on the intervention group will be advised to use the Fitbit 24 hours per day continuously throughout 6 month intervention period.
Adherence to the program will be assessed with the records of people who ceased involvement with the intervention prior to its completion and the reason for this, data from the Fitbit device kept by participants. Participants will also be asked to identify reasons for intervention adoption and adherence.
Intervention code [1] 291082 0
Treatment: Other
Intervention code [2] 291150 0
Lifestyle
Intervention code [3] 291151 0
Behaviour
Comparator / control treatment
Standard of care (Physical activity booklet advice)
Control group
Active

Outcomes
Primary outcome [1] 294194 0
Low Back Pain levels will be assessed with the numerical rating scale (NRS)
Timepoint [1] 294194 0
Baseline, weekly over a 6 month period and 12 months after randomisation.
Primary outcome [2] 294196 0
Functional disability will be assessed via the Roland–Morris Disability Questionnaire (RDQ)
Timepoint [2] 294196 0
Baseline, weekly over a 6 month period and 12 months after randomisation
Primary outcome [3] 294197 0
Care seeking for low back pain will be assessed with the use of a customized mobile WebApp. Through this mobile WebApp the participant will be able to register the number of previous treatments, symptom length, co-morbidities, number and type of visits to a health practitioner (i.e. general practitioner, physiotherapist, chiropractor, etc) and medication intake (i.e. number of pills daily). They will also be able to report any hospitalisations (patients’ presentation to emergency departments and time length of hospitalization) or if they underwent any surgical procedure.
Timepoint [3] 294197 0
Baseline, weekly over a 6 month period and 12 months after randomisation.
Secondary outcome [1] 312733 0
Physical activity will be assessed over a 7-day period using a matchbox-sized accelerometer (Actigraph GT3X+) worn on a belt at the hip.
Timepoint [1] 312733 0
Baseline, 6 months and 12 months after randomisation
Secondary outcome [2] 312734 0
Goal attainment will be assessed using the Goal Attainment Scale (GAS)
Timepoint [2] 312734 0
Baseline, 6 months and 12 months after randomisation
Secondary outcome [3] 312735 0
Quality of life will be assessed using the EuroQol questionnaire (EQ-5D)
Timepoint [3] 312735 0
Baseline, 6 months and 12 months after randomisation
Secondary outcome [4] 312736 0
Depression will be assessed using the Depression Anxiety Stress Scale (DASS)
Timepoint [4] 312736 0
Baseline, 6 months and 12 months after randomisation
Secondary outcome [5] 312737 0
Sleep quality will be assessed with the Pittsburgh Sleep Quality Index (PSQI)
Timepoint [5] 312737 0
Baseline, 6 months and 12 months after randomisation
Secondary outcome [6] 312738 0
Fear avoidance will be assessed using the Fear Avoidance Beliefs Questionnaire (FABQ)
Timepoint [6] 312738 0
Baseline, 6 months and 12 months after randomisation
Secondary outcome [7] 312739 0
Cognitive function will be assessed with the modified mini-mental state (3MS) examination
Timepoint [7] 312739 0
Baseline, 6 months and 12 months after randomisation
Secondary outcome [8] 312740 0
Lower extremity function will be assessed with the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Timepoint [8] 312740 0
Baseline, 6 months and 12 months after randomisation

Eligibility
Key inclusion criteria
Male and female adults aged over 18 years, with chronic LBP persisting for over 12 weeks but without radicular symptoms; after treatment in the physiotherapy department of The Liverpool Hospital; regular (weekly) use of a computer or internet-connected tablet device; fluency in English (verbal and written)
Minimum age
18 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Any spinal surgery in the past 12 months; evidence of nerve root, spinal cord or caudal equine compression; severe spinal stenosis indicated by signs of neurogenic claudication (grade 3 to 4); fibromyalgia, or systemic/inflammatory disorder; any other current musculoskeletal injury or contraindication to increasing physical activity levels, including any cardiorespiratory or other medical condition limiting exercise tolerance; LBP caused by involvement in a road traffic accident in the last 12 months or ongoing litigation;; current pregnancy.

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)
Potential participants who meet the study inclusion criteria will be invited to participate in the trial, after treatment discharge from the outpatient Physiotherapy department of Liverpool Hospital, Sydney Southwestern area, Australia. Patients with chronic low back pain who have received any conservative physiotherapy treatment will be informed about the trial and invited to participate. Treating physiotherapists at the hospital will identify potential participants and refer them to the research team. At treatment discharge, a research assistant will describe the study and offer participation to those who meet the inclusion criteria. Any questions will be answered and a signed consent form recorded. At this time, participants will complete baseline data.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation to intervention or control groups will occur after confirmation of eligibility and baseline assessment. Allocation will be blinded and performed using a computer-generated random allocation schedule operated by a remote researcher.
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
Type of endpoint(s)
Statistical methods / analysis
The sample size was defined in order to detect a 2-point difference between groups on the pain intensity outcome measured by the Pain Numerical Rating Scale, assuming a standard deviation of 1.9 points. Power was defined as 80% for an alpha of 5% and attrition (drop-outs) of 35%. The effect of treatment will be separately analysed for each outcome using linear mixed models with time as a repeated factor, group as a fixed factor and subjects as a random factor. The coefficient of the group x time interactions will provide estimates of the effects of interventions over time. All analyses will be performed by intention to treat and blinded to treatment group. Potential covariates that will be investigated are baseline pain and disability levels, number of previous treatments, symptom length, co-morbidities, age, and socioeconomic status.

Recruitment
Recruitment status
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] 3394 0
Liverpool Hospital - Liverpool
Recruitment postcode(s) [1] 9178 0
2170 - Liverpool

Funding & Sponsors
Funding source category [1] 290676 0
Other
Name [1] 290676 0
Medibank Health Reserach Fund
Address [1] 290676 0
Shop 2
413-415 George St
Sydney, NSW 2000
Country [1] 290676 0
Australia
Primary sponsor type
University
Name
The University of Sydney
Address
Faculty of Health Sciences
Cumberland Campus
75 East Street
SYDNEY NSW 2141
Country
Australia
Secondary sponsor category [1] 289369 0
Hospital
Name [1] 289369 0
Liverpool Hospital
Address [1] 289369 0
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170
Country [1] 289369 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 292307 0
South Western Sydney Local Health District HREC
Ethics committee address [1] 292307 0
Level 2, UNSW Clinical School
Corner of Elizabeth and Goulburn Streets
Liverpool Hospital
NSW 2170
Ethics committee country [1] 292307 0
Australia
Date submitted for ethics approval [1] 292307 0
23/01/2015
Approval date [1] 292307 0
27/03/2015
Ethics approval number [1] 292307 0
HREC/15/LPOOL/24
Ethics committee name [2] 292308 0
The University of Sydney HREC
Ethics committee address [2] 292308 0
The University of Sydney
Ethics committee country [2] 292308 0
Australia
Date submitted for ethics approval [2] 292308 0
09/03/2015
Approval date [2] 292308 0
27/03/2015
Ethics approval number [2] 292308 0

Summary
Brief summary
It is well recognized that low back pain (LBP) is a significant public health problem. The total cost of chronic LBP in Australia is estimated at $9.17 billion yearly. Expenditures are expected to grow with the increasing obesity crisis and ageing population.
Although randomised controlled trials (RCT) investigating the efficacy of conservative interventions for chronic LBP have found improvements in pain and disability associated with interventions, but patients exhibit a rapid decline in clinical outcomes after treatment discharge. These patients are likely to have recurrences of LBP and therefore seek additional care and costly, invasive procedures such as spinal surgery.
Our previous research has shown that patients with chronic LBP who engage in moderate to high levels of recreational physical activity have better prognosis of pain, disability, and quality of life than those who fail to maintain adequate levels of activity. However, adherence to such lifestyle modifications is crucial and difficult to achieve. Interventions to increase physical activity based on communication technologies are becoming popular because they facilitate patients’ access and adherence to health interventions. The use of patient-centred approaches, where patients have the opportunity to share healthcare decisions, are becoming popular in LBP and have been found to be more effective than general non-specific approaches to help patients to engage in physical activity. Surprisingly, no studies have investigated the effectiveness of a physical activity intervention, particularly with the support of mobile-health (m-health) tools on long-term outcomes in patients with chronic LBP.
We propose a RCT to investigate the effectiveness of an m-health patient-centered physical activity intervention for patients with chronic LBP after discharge from hospital. Patients in the experimental group will receive feedback from affordable and unobtrusive activity monitors to allow them to maintain leisure activity levels through lifestyle modification and use an m-health tool to monitor and motivate their progress. We hypothesise that the use of m-health monitoring and patient-centred lifestyle modification will reduce symptom recurrence, unnecessary spinal surgery and care seeking. We will evaluate this approach in patients receiving treatment in an outpatient physiotherapy department of Liverpool Hospital in the South-western health district of Sydney.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 54562 0
Dr Paulo Ferreira
Address 54562 0
The University of Sydney
75 East St
Cumberland Campus
Faculty of Health Sciences
Lidcombe, Sydney, NSW 2141
Country 54562 0
Australia
Phone 54562 0
+61 430 588 696
Fax 54562 0
Email 54562 0
paulo.ferreira@sydney.edu.au
Contact person for public queries
Name 54563 0
Miss Anita Amorim
Address 54563 0
The University of Sydney
75 East St
Cumberland Campus
Faculty of Health Sciences
Lidcombe, Sydney, NSW 2141
Country 54563 0
Australia
Phone 54563 0
+61 401 399 572
Fax 54563 0
Email 54563 0
abar3926@uni.sydney.edu.au
Contact person for scientific queries
Name 54564 0
Dr Paulo Ferreira
Address 54564 0
The University of Sydney
75 East St
Cumberland Campus
Faculty of Health Sciences
Lidcombe, Sydney, NSW 2141
Country 54564 0
Australia
Phone 54564 0
+61 430 588 696
Fax 54564 0
Email 54564 0
paulo.ferreira@sydney.edu.au

No information has been provided regarding IPD availability
Summary results
No Results