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Trial registered on ANZCTR


Registration number
ACTRN12624000745549
Ethics application status
Approved
Date submitted
13/05/2024
Date registered
17/06/2024
Date last updated
15/09/2024
Date data sharing statement initially provided
17/06/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Investigating the effect of a mHealth assisted allied health opioid tapering intervention on daily opioid use for chronic pain: the MOTION-Pilot randomised controlled trial
Scientific title
Investigating the effect of a mHealth assisted allied health opioid tapering intervention on daily opioid use for chronic pain: the MOTION-Pilot randomised controlled trial
Secondary ID [1] 312129 0
RBWH-PG0202024
Universal Trial Number (UTN)
Trial acronym
MOTION-Pilot
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 333771 0
Condition category
Condition code
Anaesthesiology 330446 330446 0 0
Pain management
Public Health 330734 330734 0 0
Health service research

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This project investigates an mHealth assisted allied health intervention for opioid tapering (mHealth Intervention). Components of this intervention include:

1) Pain ROADMAP monitoring

Pain ROADMAP was designed by our research team to help people with chronic pain to accurately identify which activities cause pain flare-ups. Pain ROADMAP monitors physical activity, symptoms and behaviour over the course of a week. People with pain wear a commercially available TGA approved activity monitor (Actigraph) and enter data into our bespoke mobile phone app. This app functions as an electric diary and records self-reported pain ratings, pain medication intake and activity participation throughout the day. The app reminds participants to enter their medication and diary data through push notification every waking hour. In addition, the app alerts participants through push notifications to enter pain intensity ratings every waking hour using a 0–10 numerical rating scale. It is estimated that data entry takes approximately 15 minutes in total per day across multiple data entries.

After participants have completed their one week monitoring period, their data is uploaded to our online portal where the data is analysed. The portal produces summary statistics for the week such as average pain intensity, percentage of time spent on productive tasks, and oral morphine equivalent daily dose (oMEDD) to monitor progress over time. In additional, a visual record of each day is produced associating specific activities with pain flare-ups using our published algorithm. The analysed output is used by clinicians to give feedback to clients/patients to help them reduce their pain flare ups, improve productivity and achieve their therapy goals.

As part of this trial, participants will receive 3 x 1-week Pain ROADMAP monitoring periods and feedback appointments that are interspersed over a 25-week treatment block. Participants will be loan a phone with the Pain ROADMAP app installed and an Actigraph activity monitor for all monitoring periods.

Data analytics from the Pain ROADMAP platform will be used to ascertain adherence to monitoring procedures as part of an assessment of treatment fidelity.

2) Individual occupational therapy treatment

The occupational therapist uses the Pain ROADMAP data to provide feedback on the daily activities that are most likely contributing to pain flare ups and to monitor progress over time. For this trial, the occupational therapist will work with participants randomised to the mHealth Intervention group to reduce the frequency and severity of pain flare ups by adapting pain provoking activities and optimising routines. Examples of activity adaptions include breaking up a pain-provoking activity (mowing the lawn for 20 mins in the morning and 20 mins in the afternoon), using assistive equipment (long handle garden tools) or changing one’s posture while doing a task (sitting while doing meal preparation). The occupational therapist will also help participants set functional goals, develop graded functional activity programs for goals and develop individualised flare up management plans. Examples of exercises for graded functional activity programs include: “start walking 15 mins every day” and “cook dinner for family once a week”. Participants randomised to the mHealth intervention group will receive 8 sessions with the occupational therapist (1 assessment session and 7 active treatment sessions) over a 25-week treatment block. All sessions will be 60 minutes in length and occur approximately once every two-three weeks.

The occupational therapist will document any deviations from the treatment protocol at the end of each treatment session using a custom-made case report form. Both attendance records and allied health practitioner documentation will be scrutinised by the research team to ascertain deviations from the treatment protocol as part of an assessment of treatment fidelity.

3) Individual pharmacy treatment

The pharmacy sessions will focus on education about opioid-related harm, advice on how to best reduce opioid dose and supported supervised tapering. Treatment will be informed by the Australian Commission on Safety and Quality in Health Care (ACSQHC) and NPS MedicineWise guidelines and resources. As education will be tailored to the participant, generic education materials will not be provided. Tapering advice may include ceasing certain opioid medications in the context of less flare ups (PRN Endone), opioid rotation (rotating Targin to Buprenorphine), or a gradual reduction in dose over time (5-10% decrease in oMEDD every 2-4 weeks). The pharmacist will use Pain ROADMAP data to understand how participants take their medications, why participants may be taking extra medication and typical patterns of pain throughout the day. Pain ROADMAP data also be used to monitor progress and provide feedback on pain levels in the context of medication changes . All treatment decision will be made in consultation with the participant, their pain specialist, and their primary care physician.

Participants randomised to the mHealth intervention group will receive 8 sessions with the pharmacist (1 assessment session and 7 active treatment sessions) over a 25-week treatment block. All sessions will be 60 minutes in length and occur approximately once every two-three weeks.

The pharmacist will document any deviations from the treatment protocol at the end of each treatment session using a custom-made case report form. Both attendance records and allied health practitioner documentation will be scrutinised by the research team to ascertain deviations from the treatment protocol as part of an assessment of treatment fidelity.

Mode of delivery
Participants will have the option to either complete their treatment over telehealth or onsite at the Tess Cramond Pain and Research Centre. The Queensland Health telehealth portal will be used for telehealth sessions. Telehealth participants will be mailed their monitoring equipment and a pre-paid Australian Post parcel satchel to return their equipment after their monitoring is completed. A hard copy app manual and links to videos of app demonstrations will be given or mailed to participants during their first appointment.
Intervention code [1] 328565 0
Behaviour
Intervention code [2] 328566 0
Rehabilitation
Comparator / control treatment
The control group will receive usual care which entails a letter to the GP with tapering advice from a pain medicine consultant.
Control group
Active

Outcomes
Primary outcome [1] 338219 0
Any change in oral morphine equivalent daily dose (oMEDD)
Timepoint [1] 338219 0
Baseline and 6-months post-intervention commencement
Secondary outcome [1] 435015 0
Pain Interference
Timepoint [1] 435015 0
Baseline and 6-months post-intervention commencement
Secondary outcome [2] 435016 0
Pain Severity
Timepoint [2] 435016 0
Baseline and 6-months post-intervention commencement
Secondary outcome [3] 435017 0
Self-reported problems related to opioid use
Timepoint [3] 435017 0
Baseline and 6-months post-intervention commencement
Secondary outcome [4] 435018 0
Self-reported opioid misuse
Timepoint [4] 435018 0
Baseline and 6-months post-intervention commencement
Secondary outcome [5] 435019 0
Self-reported substance use
Timepoint [5] 435019 0
Baseline and 6-months post-intervention commencement
Secondary outcome [6] 435029 0
Overactivity severity
Timepoint [6] 435029 0
Baseline and 6-months post-intervention commencement
Secondary outcome [7] 435030 0
Opioid tapering self-efficacy
Timepoint [7] 435030 0
Baseline and 6-months post-intervention commencement
Secondary outcome [8] 435031 0
Intervention acceptability
Timepoint [8] 435031 0
6-months post-intervention commencement
Secondary outcome [9] 435032 0
Recruitment rate
Timepoint [9] 435032 0
Cumulative data will be assessed at the conclusion of the trial.
Secondary outcome [10] 435033 0
Dropout rate
Timepoint [10] 435033 0
Cumulative data will be assessed at the conclusion of the trial.
Secondary outcome [11] 435034 0
Treatment Fidelity
Timepoint [11] 435034 0
Cumulative data will be assessed at the conclusion of the trial.

Eligibility
Key inclusion criteria
Patients will be eligible to participate in the trial if they: i) have a pain duration equal to or greater than 3 months, ii) are aged 18 - 80 years, iii) have non-malignant pain, iv) are prescribed opioids, and v) are open to engaging with allied health staff to discuss their pain medications.
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Individuals will be excluded if they: i) cannot communicate in English, ii) have a significant intellectual or cognitive impairment, iii) have active psychosocial issues including suicidal intent, or psychosis, iv) intravenous drug use, v) are currently using any implanted device for pain control (e.g., intrathecal pump, spinal cord stimulator, peripheral nerve stimulator), vi) have had surgery within the previous month or have surgery planned during the next 6 months and vii) evidence of recent aberrant drug-related behaviours (i.e. stealing or borrowing drugs from others, altering mode of administration of drug delivery and aggressive complaints about the need for more medication)

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)
Study enrolment and randomisation will be automated using an external web-based randomisation service (Study Randomizer) to ensure allocation is concealed at the time of enrolment in the study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation ratio of 1:1 and random permuted block sizes of 2, 4 and 6 will be utilised.
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
Statistical methods / analysis
In this pilot trial, the focus will be on descriptive statistics and estimation, using confidence intervals (CIs), rather than formal hypothesis testing. For normally distributed variables, we will establish the mean differences, standardised effect sizes (cohen’s d) and CIs between the two study arms at baseline (if applicable) and 6-months by using an independent sample t-test. Effect size graphs will be produced to facilitate an assessment of both statistical significance and the potential for clinical significance for findings. Effect size graphs will illustrate the mean difference between groups, 95%, 85% and 75% CIs, and the minimum clinically important difference (MCID) value (where the MCID has been previously published).

Descriptive statistics will be used to examine feasibility, acceptability, and non-normally distributed outcome measures. To facilitate an assessment of the potential clinically important difference, results will be presented with reference to published cut off scores for the Problems Subscale of Prescription Opioid Difficulties Scale, the Prescription Opioid Misuse Index and absolute oMEDD value. The proportion of participants with scores above and below cut off values for each group, at each time point, will be generated.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
19/09/2024
Actual
Date of last participant enrolment
Anticipated
27/01/2025
Actual
Date of last data collection
Anticipated
28/07/2025
Actual
Sample size
Target
50
Accrual to date
0
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 26537 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 42578 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 316486 0
Hospital
Name [1] 316486 0
The Royal Brisbane and Women's Hospital
Country [1] 316486 0
Australia
Funding source category [2] 316496 0
University
Name [2] 316496 0
The RECOVER Injury Research Centre, The University of Queensland
Country [2] 316496 0
Australia
Funding source category [3] 316497 0
Government body
Name [3] 316497 0
The Australian eHealth Research Centre, CSIRO
Country [3] 316497 0
Australia
Primary sponsor type
University
Name
The University of Queensland
Address
Country
Australia
Secondary sponsor category [1] 318670 0
Hospital
Name [1] 318670 0
Metro North Hospital and Health Service
Address [1] 318670 0
Country [1] 318670 0
Australia
Other collaborator category [1] 283032 0
Government body
Name [1] 283032 0
CSIRO
Address [1] 283032 0
Country [1] 283032 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315284 0
Metro North Health Human Research Ethics Committee A
Ethics committee address [1] 315284 0
https://metronorth.health.qld.gov.au/research/ethics-and-governance/human-research-ethics-committee
Ethics committee country [1] 315284 0
Australia
Date submitted for ethics approval [1] 315284 0
30/04/2024
Approval date [1] 315284 0
01/07/2024
Ethics approval number [1] 315284 0
HREC/2024/MNHA/107602
Ethics committee name [2] 316133 0
The University of Queensland Human Research Ethics Committee A
Ethics committee address [2] 316133 0
https://www.uq.edu.au/research/research-support/ethics-integrity-and-compliance/human-ethics
Ethics committee country [2] 316133 0
Australia
Date submitted for ethics approval [2] 316133 0
15/07/2024
Approval date [2] 316133 0
16/07/2024
Ethics approval number [2] 316133 0
2024/HE001468
Ethics committee name [3] 316134 0
CSIRO Health and Medical Human Research Ethics Committee
Ethics committee address [3] 316134 0
https://www.csiro.au/en/about/Policies/Ethical-human-research
Ethics committee country [3] 316134 0
Australia
Date submitted for ethics approval [3] 316134 0
02/08/2024
Approval date [3] 316134 0
05/08/2024
Ethics approval number [3] 316134 0
2021_046_RR

Summary
Brief summary
This study aims to develop, implement, and evaluate an allied health led mHealth assisted opioid tapering intervention for people with chronic pain on long-term opioid therapy. A pilot Randomised Controlled Trial (RCT) will be used to investigate the acceptability, feasibility and potential efficacy of this novel approach to supportive opioid tapering. Potential efficacy will be established by comparing the mHealth assisted intervention to usual care (i.e. GP correspondence) to determine potential clinically meaningful differences in health outcomes at 6 months follow up pertaining to opioid use, pain severity and pain interference (i.e. the impact of pain on one’s life). Our progression criteria for a more robust and full scale RCT for this trial are: i) adequate recruitment (equal to or greater than 6 participants/month), ii) retention (equal to or less than 25% drop out) and iii) intervention acceptability (equal to or greater than 80% of mHealth intervention participants recording a positive response on the 7-point Likert scale (i.e. score equal to or greater than 5)).
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 134218 0
Dr Nicole Andrews
Address 134218 0
RECOVER Injury Research Centre, Level 7 Surgical Treatment and Rehabilitation Service (STARS), 296 Herston Rd, Herston, QLD, 4006
Country 134218 0
Australia
Phone 134218 0
+61 7 3365 5560
Fax 134218 0
Email 134218 0
[email protected]
Contact person for public queries
Name 134219 0
Nicole Andrews
Address 134219 0
RECOVER Injury Research Centre, Level 7 Surgical Treatment and Rehabilitation Service (STARS), 296 Herston Rd, Herston, QLD, 4006
Country 134219 0
Australia
Phone 134219 0
+61 7 3365 5560
Fax 134219 0
Email 134219 0
[email protected]
Contact person for scientific queries
Name 134220 0
Nicole Andrews
Address 134220 0
RECOVER Injury Research Centre, Level 7 Surgical Treatment and Rehabilitation Service (STARS), 296 Herston Rd, Herston, QLD, 4006
Country 134220 0
Australia
Phone 134220 0
+61 7 3365 5560
Fax 134220 0
Email 134220 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All non-identifiable individual participant data collected during the trial will be made available upon reasonable request
When will data be available (start and end dates)?
From date of publication of the main findings to five years post publication
Available to whom?
Researchers who provide a methodologically sound proposal
Available for what types of analyses?
Data checking, secondary analysis of the data and meta analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
22387Study protocol  [email protected]



Results publications and other study-related documents

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