Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621001714875
Ethics application status
Approved
Date submitted
14/09/2021
Date registered
15/12/2021
Date last updated
25/10/2023
Date data sharing statement initially provided
15/12/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Opioid weaning and eye markers
Scientific title
A proof of concept study to detect the eye biomarkers in opioid-dependent chronic pain sufferers using an opioid tapering digital health application
Secondary ID [1] 305171 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Pain 323440 0
Opioid dependency 323441 0
Condition category
Condition code
Anaesthesiology 320994 320994 0 0
Pain management
Mental Health 321471 321471 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study follows the progress of weaning from opioids, in opioid dependent patients on an oral morphine equivalent of more than 50mg for more than 3 months, using eye biomarkers in order to establish that accurate ocular-marker data may be collected using BioEye, thus facilitating the monitoring and assessment of the effects of opioid tapering.

The eCovery application provides education about chronic pain, opioids, sleep, anxiety and depression to help the patient understand the reasons for weaning and why the journey can be difficult. It provides a video message of the consultation so the patient can review the plan at any time and show it to other healthcare professionals. It provides a visual display of their opioid dose and their tapering progress. The eCovery application is loaded onto the patient’s mobile phone and IT support is provided by eCovery. The eCovery application is experimental.

As with usual care, potential participants will be assessed by a chronic pain specialist. As part of usual care weaning from opioids will be managed by the treating clinician and patient. Patients will be seen every two to four weeks over a period of three months. The visits at Baseline, week 3, week 7 and week 11 will take approximately 30 minutes. The Baseline visit will occur at the beginning of the opioid tapering program. Each visit will be a standard face-to-face consultation with the eCovery pain specialist who will use the eCovery app to track opioid use and BioEye to collect ocular marker data by tracking simple eye movement tasks.

No additional visits beyond routine, scheduled, clinical visits will be required.

Only participants taking part in the study will be offered the opioid tapering digital health application.

Both eCovery and BioEye are being registered.
BioEye is used only during routine, scheduled, clinical visits.
The collection of ocular marker data using BioeEye will take 5-10minutes.
The doctor enters the opioid medication information into the eCovery app following the consultation. Participants enter their data when and if they wish. There is no set frequency for that.
Intervention code [1] 321638 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 328861 0
Asymmetry in pupils’ size measured with BioEye
Timepoint [1] 328861 0
Baseline, week 3, week 7 and week 11 post-commencement of the opioid tapering program,
Primary outcome [2] 328862 0
Near point convergence measured with BioEye, assessed by testing closer and closer points of gaze on an object.
Timepoint [2] 328862 0
Baseline, week 3, week 7 and week 11 post-commencement of the opioid tapering program,
Primary outcome [3] 328863 0
Pupils response to light measured with BioEye, assessed as pupil size following application of a light stimulus.
Timepoint [3] 328863 0
Baseline, week 3, week 7 and week 11 post-commencement of the opioid tapering program,
Secondary outcome [1] 400665 0
Average velocity of constriction measured with BioEye.
Timepoint [1] 400665 0
Baseline, week 3, week 7 and week 11 post-commencement of the opioid tapering program,
Secondary outcome [2] 400666 0
Average velocity of dilation measured with BioEye
Timepoint [2] 400666 0
Baseline, week 3, week 7 and week 11 post-commencement of the opioid tapering program,
Secondary outcome [3] 400667 0
Blink rate measured with BioEye
Timepoint [3] 400667 0
Baseline, week 3, week 7 and week 11 post-commencement of the opioid tapering program,
Secondary outcome [4] 400668 0
Ptosis (Upper-eyelid drop) measured with BioEye
Timepoint [4] 400668 0
Baseline, week 3, week 7 and week 11 post-commencement of the opioid tapering program,

Eligibility
Key inclusion criteria
1. Age over 18 years.
2. Male, or female. Women of childbearing age can be included
3. Must be on an oral morphine equivalent of more than 50mg for more than 3 months.
4. Patient must be deemed by the treating physician able to give informed consent.
5. The patient must be deemed able, physically and psychologically, to cooperate with the study.
6. Any prescribed opioids.

Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Pregnant.
2. Current substance misuse disorder. Patients on methadone and high dose buprenorphine (eg Suboxone) will be excluded. This is as the eCovery digital health application is not designed to help patients taking opioid substitution therapy for severe opioid use disorder.
3. Significant mental health disorder.
4. Do not have a mobile phone, or internet access that can use the eCovery application.
5. Do not have basic English speaking ability, as the eCovery application’s education is in English.
6. Do not wish to taper their opioids.
7. Any medical condition that would make tapering of opioids not possible at that stage.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
No formal sample size calculations have been undertaken. Standard errors for BioEye data are unavailable and there are too many variables to be taken into account. The estimated sample size has been based on sample size for similar studies.

Specific statistical analyses in relation to the a priori hypotheses will include examining BioEye’s primary and secondary indicator variables for an association between:
1) Baseline and opioid tapering measures
2) Opioid tapering and published clinical measures

Statistical analyses will consider both parametric and non-parametric tests, where appropriate, depending on the normality of the data. Comparisons will be made between baseline and opioid tapering timepoints. In this context we expect that using between-groups, repeated-measures, or mixed ANOVA tests (or similar non-parametric approaches where appropriate) to assess group and time point differences will be suitable. Additionally, efforts will be made to model the effects of relevant variables including various primary and secondary indicators (see Expected Outcomes section), either within regression models or as covariates.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
The sponsor eCovery ceased trading resulting in the closure of the study.
Date of first participant enrolment
Anticipated
1/01/2022
Actual
7/10/2022
Date of last participant enrolment
Anticipated
31/12/2023
Actual
21/06/2023
Date of last data collection
Anticipated
31/03/2024
Actual
21/06/2023
Sample size
Target
40
Accrual to date
Final
6
Recruitment in Australia
Recruitment state(s)
TAS,VIC
Recruitment postcode(s) [1] 35251 0
3101 - Kew
Recruitment postcode(s) [2] 35252 0
3041 - Essendon North
Recruitment postcode(s) [3] 35624 0
3550 - Bendigo
Recruitment postcode(s) [4] 41600 0
7250 - Launceston
Recruitment postcode(s) [5] 41601 0
3109 - Doncaster East

Funding & Sponsors
Funding source category [1] 309616 0
Commercial sector/Industry
Name [1] 309616 0
eCovery
Country [1] 309616 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
eCovery
Address
Level 3, 534 Church Street, Cremorne, Vic 3121
Country
Australia
Secondary sponsor category [1] 310631 0
None
Name [1] 310631 0
Address [1] 310631 0
Country [1] 310631 0
Other collaborator category [1] 281976 0
Commercial sector/Industry
Name [1] 281976 0
BioEye
Address [1] 281976 0
BioEye Pty Ltd,
C/- Quantiphy
Level 1, 97 Grafton Street
Bondi Junction
NSW 2022
Country [1] 281976 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309338 0
Bellberry Human Research Ethics Committee A
Ethics committee address [1] 309338 0
Ethics committee country [1] 309338 0
Australia
Date submitted for ethics approval [1] 309338 0
04/08/2021
Approval date [1] 309338 0
15/11/2021
Ethics approval number [1] 309338 0
2021-05-500

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 113818 0
Dr Symon McCallum
Address 113818 0
Precision Brain Spine and Pain Centre
PO Box 7054, Doncaster East, VICTORIA 3109
Country 113818 0
Australia
Phone 113818 0
+61 431 835 700
Fax 113818 0
Email 113818 0
drsymonmccallum@precisionhealth.com.au
Contact person for public queries
Name 113819 0
Symon McCallum
Address 113819 0
Precision Brain Spine and Pain Centre
PO Box 7054, Doncaster East, VICTORIA 3109
Country 113819 0
Australia
Phone 113819 0
+61 431 835 700
Fax 113819 0
Email 113819 0
drsymonmccallum@precisionhealth.com.au
Contact person for scientific queries
Name 113820 0
Symon McCallum
Address 113820 0
Precision Brain Spine and Pain Centre
PO Box 7054, Doncaster East, VICTORIA 3109
Country 113820 0
Australia
Phone 113820 0
+61 431 835 700
Fax 113820 0
Email 113820 0
drsymonmccallum@precisionhealth.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data that underlie the published results, after deidentification (text, tables, figures, and appendices).
When will data be available (start and end dates)?
Beginning 9 months and ending 36 months following article publication.
Available to whom?
Researchers who provide a methodologically sound proposal, approved by the Sponsor
Available for what types of analyses?
To achieve the aims in the approved proposal
How or where can data be obtained?
Requests should be directed to drsymonmccallum@ecovery.com.au
To gain access, data requestors will need to sign a data access agreement.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
13184Study protocol  drsymonmccallum@precisionhealth.com.au
13185Informed consent form  drsymonmccallum@precisionhealth.com.au



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.