Cognitive Impairment Clinical Trial
— coffee-cupOfficial title:
Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study
NCT number | NCT03036917 |
Other study ID # | SE-4-2016 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2018 |
Est. completion date | May 3, 2019 |
Verified date | July 2018 |
Source | Zealand University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study aims to investigate the cognitive function of patients in the opioid reduction
programme at the multidisciplinary pain centre at Zealand University Hospital Køge.
The patients will be tested before, halfway through, and after the programme.
Status | Completed |
Enrollment | 50 |
Est. completion date | May 3, 2019 |
Est. primary completion date | May 3, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients > 18 years of age and able to provide a written consent - Participating in the opioid reduction programme Exclusion Criteria: - Not able to speak and understand Danish - Patients suffering from dementia or psychosis |
Country | Name | City | State |
---|---|---|---|
Denmark | Holbæk Hospital | Holbæk | |
Denmark | Zealand University Hospital | Køge |
Lead Sponsor | Collaborator |
---|---|
Zealand University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cognitive function before opioid reduction | Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | |
Secondary | Cognitive function at halfway point | Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | |
Secondary | Cognitive function at end of reduction | Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). | When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | |
Secondary | Executive function before opioid reduction | Executive function measured by Trail making test A and B | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | |
Secondary | Executive function at halfway point | Executive function measured by Trail making test A and B | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | |
Secondary | Executive function at end of reduction | Executive function measured by Trail making test A and B | When reduction is complete (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | |
Secondary | Morphine use before reduction | Morphine equivalents before reduction | At first visit to pain clinic (Individual date, inclusion is possible throughout study period) | |
Secondary | Morphine use after reduction | Morphine equivalents after reduction | At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | |
Secondary | Use of other analgesics before reduction | Use of any other analgesic | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | |
Secondary | Use of other analgesics at halfway point | Use of any other analgesic | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | |
Secondary | Use of other analgesics after reduction | Use of any other analgesic | At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | |
Secondary | Quality of life before reduction | Quality of life measured by SF36 | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | |
Secondary | Quality of life at halfway point | Quality of life measured by SF36 | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | |
Secondary | Quality of life at end of reduction | Quality of life measured by SF36 | At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) | |
Secondary | Risk of anxiety and depression before reduction | Risk of anxiety and depression measured by Hospital anxiety and depression scale | At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period) | |
Secondary | Risk of anxiety and depression at halfway point | Risk of anxiety and depression measured by Hospital anxiety and depression scale | When opioids are reduced to half the dose (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 6 months) | |
Secondary | Risk of anxiety and depression at end of reduction | Risk of anxiety and depression measured by Hospital anxiety and depression scale | At end of reduction (Opioid tapering is an individual process, and thus the time frame is individual, based upon morphine-reduction regimen, approximately 12 months) |
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