Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain (coffee-cup)
3 lipca 2019 zaktualizowane przez: Zealand University Hospital
Cognitive Function Before and After Opioid Reduction in Patients With Chronic Pain A Prospective Cohort Study
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.
Przegląd badań
Status
Zakończony
Szczegółowy opis
The number of patients with chronic non-malignant pain is high and constant. An estimated 3-5% of the population use opioids daily. These patients have a lower quality of life and a higher use of healthcare services.
This leads to enormous costs, both human and economic. Many patients lose their ability to work, not only because of the pain, but also because of their treatment.
For a long period, opioids have been prescribed for chronic pain, even though the evidence is scarce.
A rising conscience about opioid use is on the way, and now, there is a tendency to reduce, rather than increase opioids.
The reasons are many: Constipation, inability to drive, a sense of drowsiness and no relief of pain, just to name a few. Furthermore, opioids may have decreased effect over time or may even lead to higher levels of pain.
Many patients are at first reluctant to start the reduction programme. Mostly because the patients may not be aware of the effects, the drugs are having on them. Many patients value their opioid treatment as positive and necessary, in spite of the many adverse effects.
The investigators wanted to test the cognitive function of patients before, during and after opioid reduction. The results can be used to help patients understand the deleterious effects of high opioid usage, and can also be used to motivate the individual patient along the way.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
50
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
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Holbæk, Dania, 4300
- Holbæk Hospital
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Køge, Dania, 4600
- Zealand University Hospital
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Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat i starsze (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Wszystko
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Patients with chronic pain, treated with opioids and participating in the opioid reduction programme at the Multidiscipinary Pain Centre at Zealand University Hospital Køge
Opis
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
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Modele obserwacyjne: Kohorta
- Perspektywy czasowe: Spodziewany
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Cognitive function before opioid reduction
Ramy czasowe: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Cognitive function at halfway point
Ramy czasowe: 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)
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Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
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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)
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Cognitive function at end of reduction
Ramy czasowe: 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)
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Cognitive function measured with the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).
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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)
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Executive function before opioid reduction
Ramy czasowe: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Executive function measured by Trail making test A and B
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Executive function at halfway point
Ramy czasowe: 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)
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Executive function measured by Trail making test A and B
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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)
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Executive function at end of reduction
Ramy czasowe: 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)
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Executive function measured by Trail making test A and B
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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)
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Morphine use before reduction
Ramy czasowe: At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
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Morphine equivalents before reduction
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At first visit to pain clinic (Individual date, inclusion is possible throughout study period)
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Morphine use after reduction
Ramy czasowe: 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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Morphine equivalents after reduction
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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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Use of other analgesics before reduction
Ramy czasowe: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Use of any other analgesic
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Use of other analgesics at halfway point
Ramy czasowe: 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)
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Use of any other analgesic
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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)
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Use of other analgesics after reduction
Ramy czasowe: 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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Use of any other analgesic
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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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Quality of life before reduction
Ramy czasowe: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Quality of life measured by SF36
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Quality of life at halfway point
Ramy czasowe: 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)
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Quality of life measured by SF36
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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)
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Quality of life at end of reduction
Ramy czasowe: 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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Quality of life measured by SF36
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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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Risk of anxiety and depression before reduction
Ramy czasowe: At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Risk of anxiety and depression measured by Hospital anxiety and depression scale
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At first visit to pain clinic (Day 1)(Individual date, inclusion is possible throughout study period)
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Risk of anxiety and depression at halfway point
Ramy czasowe: 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)
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Risk of anxiety and depression measured by Hospital anxiety and depression scale
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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)
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Risk of anxiety and depression at end of reduction
Ramy czasowe: 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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Risk of anxiety and depression measured by Hospital anxiety and depression scale
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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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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Stine Estrup, MD, Zealand University Hospital
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
1 stycznia 2018
Zakończenie podstawowe (Rzeczywisty)
3 maja 2019
Ukończenie studiów (Rzeczywisty)
3 maja 2019
Daty rejestracji na studia
Pierwszy przesłany
10 stycznia 2017
Pierwszy przesłany, który spełnia kryteria kontroli jakości
25 stycznia 2017
Pierwszy wysłany (Oszacować)
31 stycznia 2017
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
5 lipca 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
3 lipca 2019
Ostatnia weryfikacja
1 lipca 2018
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- SE-4-2016
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
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