ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12618001494224

Ethics application status

Approved

Date submitted

14/08/2018

Date registered

5/09/2018

Date last updated

2/03/2022

Date data sharing statement initially provided

15/05/2019

Date results information initially provided

15/05/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

EHealth to empower patients with Musculoskeletal Pain in Rural Australia (EMPoweR) a randomized controlled trial.

Scientific title

Does a tailored physical activity program and a progressive resistance home exercise program delivered using e-Health and health coaching improves physical function in individuals with chronic low back pain and/or knee osteoarthritis who live in rural Australia compared to usual care?

Secondary ID [1]

Nil known.

Universal Trial Number (UTN)

Trial acronym

Linked study record

N/A

Health condition

Health condition(s) or problem(s) studied:

Knee Osteoarthritis

Non-specific chronic low back pain

Condition category

Condition code

Musculoskeletal

Osteoarthritis

Musculoskeletal

Other muscular and skeletal disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

The intervention group will be the E-health group and the control group will be the usual care group.
Participants in the e-health intervention group will receive a tailored physical activity plan and a progressive resistance exercise program designed during remote consultations with a health coach using the Physitrack® (health coach end), and Physiapp® (participant end) web applications (Physitrack® Ltd, LDN, UK). Also, their adherence and attendance rate will be electronically recorded through this web applications, with an independent username and password for each participant.
Participants will be equipped with (i) a welcome booklet with an overview of the intervention components and instructions on how to use the Physiapp® web application (Web browser, Android or iOS app) at home and (ii) an exercise kit consisting of a range of resistance bands, yoga mat, and cuff weights. The intervention will be delivered over a 3 month period and guided by a maximum total of eight remotely-delivered consultations with a health coach. The initial consultation will last one hour, while subsequent consultations will be 30 minutes. The health coach will be a qualified health professional (such as a physiotherapist, exercise physiologist, or final year physiotherapy student under supervision) with further training in an industry accredited health coaching course (for example, the combined level 1 and 2 at http://www.wellnesscoachingaustralia.com.au).

During the health coach consultations, a home-exercise program will be designed according to patient preferences, individual goals, and the performance of remotely supervised exercises. The initial exercise prescription will have a dosage of 2 sets of 8-15 repetitions; 2 to 3 minute rest in between sets; up to 4 total exercises to promote early adherence; with a frequency of 3 times a week. Selected exercises will target the knee extensors and trunk musculature in both groups before further individualisation is made. After a 2 week period of familiarisation to promote early adherence, exercises will be performed to equal or greater than 5/10 (hard) on the modified Borg Rating of Perceived Exertion scale. Resistance will be provided by using body weight, resistance bands, or cuff weights to modify the difficulty of an exercise. The exercise dose used in this study is based on both the American College of Sport Medicine’s minimum recommendations for maintaining health, and previous studies using a similar intensity and frequency in non-specific chronic Low Back Pain (LBP) and knee OA populations. Modified exercises and dose will be provided for participants that are having trouble reaching this dosage initially or if, for example, muscular endurance is more appropriate. A 5-10 minute warm up and cool down will be included before and after each home exercise session focusing on joint range of motion and relaxation. Participants will be able to see the details of the exercise program, access video resources, record the details of each session and view their progress using the Physiapp® web application. Subsequent consultations will allow modification or progression of exercises if appropriate.

The physical activity plan will be implemented according to the principles used in our previous study of physical activity for musculoskeletal pain. The focus of the program will be on a gradual increase in physical activity where participants will be encouraged to devise fortnightly goals to suit and advance their physical activity levels. Each health coach will be trained in the principles of health coaching to facilitate the process. The plan will be specifically tailored to each participant and will involve goal setting, monitoring, and progression of goals using the web application.

The usual care provided in this trial is described as de facto usual care; this includes the wide range of care practices provided in a community which are unrestricted by study protocols or rules. This is in contrast to standardised or protocolised usual care which may not reflect the wide range of care found in the community as it may change during the conduct of the trial. Due to the nature of de facto usual care and the dual recruitment strategy used in this trial, treatments provided to participants in this group will be self-reported by using a study logbook to fill in throughout the study period. The exact treatments and care providers involved will vary depending on the participant’s location and source of recruitment. Common practice is likely to involve education, home exercises, and if within close vicinity to a health site, some additional supervised exercises tailored to the individual and may or may not involve additional manual therapy techniques.

All participants who get allocated into the de facto usual care group will be provided with assistance on how to do so over the telephone and via email with a member from the research team. Participants recruited from a) Dubbo and Orange Hospital outpatient physiotherapy departments will have an appointment already scheduled and therefore will only require a reminder and instructions to continue as usual. Participants recruited from b) the general community will be asked a series of questions about the health care site they were intending to access before entering the study. Assistance will be provided to those who are unaware of what options are available in their local community with the aid of the ‘find a health service’ tool on the healthdirect website, a health service directory supported by the governments of Australia (https://www.healthdirect.gov.au/). A referral letter will then be provided to each participant and the respective health care site mutually decided upon. Costs may be incurred to participants depending on where they decide to go.

Intervention code [1]

Treatment: Other

Intervention code [2]

Lifestyle

Intervention code [3]

Behaviour

Comparator / control treatment

The usual care provided in this trial is described as de facto usual care; this includes the wide range of care practices provided in a community which are unrestricted by study protocols or rules. This is in contrast to standardised or protocolised usual care which may not reflect the wide range of care found in the community as it may change during the conduct of the trial. Due to the nature of de facto usual care and the dual recruitment strategy used in this trial, treatments provided to participants in this group will be self-reported by using a study logbook to fill in throughout the study period. The exact treatments and care providers involved will vary depending on the participant’s location and source of recruitment. Common practice is likely to involve education, home exercises, and if within close vicinity to a health site, some additional supervised exercises tailored to the individual and may or may not involve additional manual therapy techniques.

All participants who get allocated into the de facto usual care group will be provided with assistance on how to do so over the telephone and via email from the e-health health coach. Participants recruited from a) Dubbo and Orange Health Service outpatient physiotherapy departments will have an appointment already scheduled and therefore will only require a reminder and instructions to continue as usual. Participants recruited from b) the general community will be asked a series of questions about the health care site they were intending to access before entering the study. Assistance will be provided to those who are unaware of what options are available in their local community with the aid of the ‘find a health service’ tool on the healthdirect website, a health service directory supported by the governments of Australia (https://www.healthdirect.gov.au/). A referral letter will then be provided to each participant and the respective health care site mutually decided upon. Costs may be incurred to participants depending on where they decide to go.

Control group

Active

Outcomes

Primary outcome [1]

Physical function assessed using the Patient-Specific Functional Scale (PSFS)

Timepoint [1]

Baseline, 3 and 6 months post-randomization

Secondary outcome [1]

Average pain during the last week will be measured using an 11-point Numeric Rating Scale

Timepoint [1]

Baseline, 3 and 6 months post-randomization

Secondary outcome [2]

Condition specific activity limitation assessed using the Roland-Morris Disability Questionnaire (RDQ) and/or the Western Ontario and McMaster Osteoarthritis Index (WOMAC) physical function subscale

Timepoint [2]

Baseline, 3 and 6 months post-randomization

Secondary outcome [3]

Measure of opinion and satisfaction:
i) Overall experience with the study;
ii) What they liked and what they did not like about the study;
iii) Difficulties in answering the follow-up questionnaires.
iv) How the process of treatment they received could be improved or be more pleasant ;
v) Opinions regarding the effectiveness of the intervention to improve function and pain

Timepoint [3]

3 months follow up

Secondary outcome [4]

Quality of life will be captured using the Assessment of Quality of Life questionnaire (AQoL-8D), a self-reported 15-item questionnaire measuring five dimensions of health status; illness, independent living, social relationships, physical senses and psychological well-being.

Timepoint [4]

3 months and 6 months follow-up

Secondary outcome [5]

Physical activity will be measured using the short-form of the Self-reported International Physical Activity Questionnaire (IPAQ), which consists of 8 items to estimate physical activity (moderate to vigorous) and inactivity (time spent sitting).

Timepoint [5]

3 months and 6 months follow-up

Secondary outcome [6]

Adverse event assessment

Timepoint [6]

Adverse events will be assessed weekly during a 3-month period using a paper-based study logbook and be closely monitored by the research team.

Secondary outcome [7]

Measure of attendance and adherence

Timepoint [7]

Attendance and adherence will be assessed weekly during a 3-month period using a paper-based study logbook and be closely monitored by the research team.

Secondary outcome [8]

Measure of follow-up rate

Timepoint [8]

the number of participants in each group who complete the baseline and follow-up assessments will be recorded throughout the study

Secondary outcome [9]

The Pain self-efficacy questionnaire

Timepoint [9]

baseline, 3 and 6 months post-randomization

Eligibility

Key inclusion criteria

Non-specific LBP and/or knee pain lasting for at least 3 months. Participants who report both conditions will be stratified based on their primary complaint by reporting which condition concerns them the most.
Pain level: LBP: Equal or greater than 3/10 on the 11-point numeric pain rating scale in the past week and knee: Equal or greater than 3/10 on the 11-point numeric pain rating scale over most days of the past month.
Be in the process of seeking care through Dubbo or Orange outpatient physiotherapy department or are intending to access care (which incur costs to patients or healthcare system) in the next 3 months for their back and/or knee pain
Reside in very remote, remote, inner and outer regional areas (based on the Australian Standard Geographical Classification Remoteness Area)
Be fluent in English (verbal and written)
Have adequate hearing and eyesight
Independent ambulatory status
Have current internet access and access to it at least once a month
Own an internet-capable device with a display, camera, microphone and speaker (smartphone, tablet or computer).
Have a self-rated ability to use the internet at-least fair (using a 4-item scale from poor, fair, good to excellent)
Willingness to provide informed consent and willingness to participate and comply with the study requirements.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

Recent or imminent spinal surgery (within 12 months)
Recent or imminent knee surgery (arthroscopy within 6 months; knee replacements/osteotomy within 12 months)
Any recent corticosteroid injections (knee or back in the past 6 months)
Evidence of radiculopathy, nerve root, spinal cord, cauda equine compression or lumbar neurogenic claudication
Any known suspected serious spinal pathology (fracture, metastatic, inflammatory or infective diseases, widespread neurological disorder)
LBP caused by involvement in a road traffic accident in the last 12 months or ongoing litigation
Have a comorbid condition that would prevent active participation in performing strengthening exercises at home or increasing physical activity levels
Diagnosis of fibromyalgia or a systematic arthritic condition
Current or planned pregnancy
Recent fall history deemed to impose risk for potential injury

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)

Participants will be recruited from Dubbo and Orange Hospitals in the first recruitment strategy. Individuals who report LBP or knee pain for at-least 3 months will be identified from the outpatient physiotherapy departments at Dubbo and Orange hospitals who are identified on waiting lists or recent intake forms. Those individuals will be contacted by hospital staff during a routine telephone call to schedule an appointment and will be provided with information about the trail. If interested and verbal consent is given, individual contact details will be entered into a secure REDCap (Research Electronic Data Capture) web survey by hospital staff. They will then be directed by an email to a study website with further information and online screening questions. The research team will contact those who pass the online screening to ask follow up telephone screening questions.

Participants will be recruited from the general community in rural and remote NSW in the second recruitment strategy. Individuals who are intending to seek care for their symptoms will be identified through the use of print, radio, and social media advertisements. We will distribute advertisement flyers through University of Sydney platforms and relevant external organisations such the as the NSW farmers association and the Women’s Country Association of NSW. The online method of delivery will include email newsletters and social media platforms including Facebook, Twitter, and Instagram. Hard copies of advertisement flyers will also be posted on public notice boards, placed in local businesses, and handed out at events (e.g. National Field Days) in rural and remote NSW where potential participants will be. Study advertisements will direct individuals to a study website or to contact the research team to receive further information. Participants will then follow the same steps found in the first recruitment strategy involving an online screening questionnaire and telephone screening questionnaire to complete the screening process.
If deemed eligible they will be invited and directed to a participant information sheet, a consent form, and the online baseline questionnaire.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation will be blinded and performed using a computer-generated random allocation schedule operated centrally at the University of Sydney by a remote research assistant using the REDCap web application. Participants, hospital staff, and the e-health coach will be notified, via automatic REDCap emails, to which group the participant has been randomly allocated too. For participants recruited from Dubbo and Orange hospital, a total timeframe of one week will be required to complete the recruitment process. Participants allocated to the e-health intervention will schedule their first remote consultation over email or telephone with the e-health coach. They will also be sent intervention resources including exercise equipment using parcel post. Participants in the usual care group will be provided with telephone and email assistance in continuing the process of accessing health care (which incur costs to patients or healthcare system) they were planning or intending before entering the study. Both groups will receive a study logbook to record treatment details, medication use, adverse events and travel details.

Masking / blinding

Open (masking not used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A total sample of 156 participants was required based on a between-group difference of three points on the trial’s primary outcome (PSFS at three months). This effect size has been reported by patients with low back and knee pain as the minimum clinically important difference expected for conservative treatments. (37,38) The sample size was based on 80% power (Type I error of 0.05) (37-39), allowing for a loss to follow-up rate of 15% at three months.
Descriptive characteristics and baseline outcome measures were used to assess baseline comparability between groups. To assess the overall levels of disability across participants with back and knee pain, scores on the RMDQ and WOMAC disability scales were standardised to a scale ranging from 0 to 100 (with lower values indicating lower disability). Quality of life was collected from the first 34 participants using the validated Medical Outcomes Study Short Form 12 (SF-12 v1). Subsequently, the trial protocol was amended and the AQoL-8D was used in the remaining 122 participants to allow for a health economic analysis (protocol amendment accepted on 23rd of May 2019). Scores on the SF-12 v1 and AQoL-8D were standardised to a scale of 0 to 100.
Based on the responses from the IPAQ-SF, a variable was created to calculate the proportion of participants who met the 2020 WHO physical activity guidelines. (29) Participants that engaged in at least 75 minutes of vigorous-intensity physical activity, or at least 150 minutes of moderate-intensity physical activity, or at least 150 minutes of combined moderate and vigorous-intensity physical activity per week, on at least two separate days, were considered to have met the 2020 WHO physical activity guidelines.
An intention to treat analysis was performed comprising all participants in their respective randomly allocated treatment groups. No attempt to impute missing values was made. The following covariates were accounted for in the models if found to be of a clinical magnitude difference between groups: baseline pain and disability levels, symptom duration, number of comorbidities, and age. The effect of group allocation on continuous outcomes (e.g., physical function, physical activity) was assessed through group*time interaction terms using linear mixed models with the baseline value of the outcome included as a covariate (mixed command in Stata 15). (40) A subgroup analysis stratified by condition (low back pain and knee osteoarthritis) was defined a priori and performed separately if the group*time*condition interaction term was found to be statistically significant at the .05 level. Analyses were conducted using Stata version 15 and statistical significance was set at 5%. A statistician blinded to group allocation performed all analyses.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

10/10/2018

Actual

18/01/2019

Date of last participant enrolment

Anticipated

1/11/2021

Actual

8/06/2021

Date of last data collection

Anticipated

1/05/2022

Actual

30/09/2021

Sample size

Target

156

Accrual to date

Final

156

Recruitment in Australia

Recruitment state(s)

ACT,NSW,NT,QLD,SA,TAS,WA,VIC

Recruitment hospital [1]

Dubbo Base Hospital - Dubbo

Recruitment hospital [2]

Orange Health Service - Orange

Recruitment postcode(s) [1]

2830 - Dubbo

Recruitment postcode(s) [2]

2800 - Orange

Recruitment postcode(s) [3]

2141 - Lidcombe

Funding & Sponsors

Funding source category [1]

University

Name [1]

The Sydney Musculoskeletal, Bone & Joint Health Alliance,

Address [1]

The University of Sydney, Australia. 75 East St, Lidcombe NSW 2141.

Country [1]

Australia

Funding source category [2]

Commercial sector/Industry

Name [2]

Medibank private

Address [2]

720 Bourke Street, Docklands, VIC 3008

Country [2]

Australia

Primary sponsor type

University

Name

The University of Sydney

Address

The University of Sydney, Faculty of Health Sciences Cumberland Campus 75 East Street, Lidcombe, Sydney, NSW 2141 Australia

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Hospital

Name [1]

Dubbo Health Service

Address [1]

Australia. Myall Street. Dubbo NSW 2830

Country [1]

Australia

Other collaborator category [2]

Hospital

Name [2]

Orange Health Hospital, Australia

Address [2]

Forest Road (PO Box 319), Orange NSW 2800

Country [2]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Sydney Local Health District Ethics Review Committee (RPAH Zone) [EC00113]

Ethics committee address [1]

Level 11, KGV Building Missenden Road, Camperdown, NSW 2050, Sydney.

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

15/06/2018

Approval date [1]

04/09/2018

Ethics approval number [1]

X18-0226

Summary

Brief summary

This study aim is to assess the feasibility of implementing an e-health-supported intervention comprised of a tailored physical activity plan and a progressive resistance exercise program for people living in rural Australia with chronic non-specific low back pain (LBP) and/or knee osteoarthritis (OA) in comparison to usual care.
Participants allocated to the e-health intervention group (n=78), will receive a tailored physical activity and progressive resistance exercise program delivered by remote health coach consultations. Usual care participants (n=78) will receive usual care.
We hypothesise that the implementation of this e-health intervention will be feasible and demonstrate preliminary efficacy.

Trial website

https://www.theempowerstudy.com/

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Paulo Ferreira

Address

The University of Sydney Faculty of Health Sciences, Cumberland Campus 75 East Street, Lidcombe, Sydney, NSW 2141
Country: Australia

Country

Australia

Phone

+61 2 9351 9397

Fax

+61 2 9351 9601

[email protected]

Contact person for public queries

Name

Mr Carlos Ivan Mesa Castrillon

Address

The University of Sydney Faculty of Health Sciences Cumberland Campus 75 East Street, Lidcombe, Sydney, NSW 2141

Country

Australia

Phone

+61 420730783

Fax

[email protected]

Contact person for scientific queries

Name

Dr Paulo Ferreira

Address

The University of Sydney Faculty of Health Sciences Cumberland Campus 75 East Street, Lidcombe, Sydney, NSW 2141
Country: Australia

Country

Australia

Phone

+61 2 9351 9397

Fax

+61 2 9351 9601

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

Individual participant data is confidential and will be stored and captured electronically involving the use of 1) a Research Electronic Data Capture (REDCap) project and 2) the Physitrack/app® application.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
2102	Ethical approval					375539-(Uploaded-15-05-2019-12-42-55)-Study-related document.pdf

Results publications and other study-related documents

Documents added manually

Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
Conference abstract	No			375539-(Uploaded-24-02-2022-11-19-17)-Other results publication.docx

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	EHealth to empower patients with musculoskeletal pain in rural Australia (EMPoweR) a randomised clinical trial: study protocol.	2021	https://dx.doi.org/10.1186/s12891-020-03866-2

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically