None listed
Conditions
Brief summary
The purpose of this study is to determine whether the BioEye application will provide eye marker information that may assist medical clinicians in administering pain management programs, to reduce opioid dependency for chronic pain sufferers. The hypothesis being tested is that opioid withdrawal can be detected by abnormalities in BioEye measurements, and these will correlate to subjective assessment of withdrawal. The study asks opioid dependent chronic pain patients to use the experimental eCovery app to monitor opioid use and have measurements of eye movement made using the BioEye eye tracking application at clinic visits over a three month period.
Interventions
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 w
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.
Sponsors
eCovery
Study design
Allocation
Non-randomised trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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.
Outcome results
None listed