Partnership in Medication Management (PIMM) in Patients With Mood Disorders (PIMM)
17 listopada 2015 zaktualizowane przez: St. Joseph's Healthcare Hamilton
Partnership in Medication Management (PIMM): The Effects of One-on-one Medication Training on Medication Adherence in Patients With Mood Disorders
Investigators are doing this study to examine if a new personalized education program for patients with mood disorders (depression and bipolar disorders) will help them take their medications as prescribed by doctors.
Investigators will teach patients about how, when and why it is important for them to take their medications as prescribed.
Also, investigators will ask patients why they do not take medications as prescribed.
Furthermore, investigators will examine whether our education program might save money if it prevents problems related to not taking medication.
Przegląd badań
Status
Nieznany
Interwencja / Leczenie
Szczegółowy opis
The efficacy of anti-depressants or lithium reported in clinical trials differs from clinical experience. Various factors such as non-adherence to treatment and poor tolerability to medications have been related to treatment non-response or treatment failure in mood disorders (major depressive disorder and bipolar disorder). Premature discontinuation of treatment for mood disorders is common. The long treatments, the patients' beliefs about medications, the lack of knowledge about the medication/treatment purpose, benefits, dosage, and side effects and the relationship between patient and healthcare providers affect treatment continuation.
Investigators are proposing a sequential explanatory mixed methods study to investigate a novel program for medication training in persons with mood disorders. The ultimate purpose of the program is to improve medication adherence in these persons. The primary component of the present study will be quantitative, i.e., a randomized controlled trial with 12 months of follow-up to examine the effect of one-on-one medication training, including the use of a checklist system, on medication adherence in patients with mood disorders. The training program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects. The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication. Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications. To the best of the investigators' knowledge, no research has comprehensively examined whether one-on-one medication training, as described above, may improve medication adherence in patients with mood disorders.
Typ studiów
Interwencyjne
Zapisy (Oczekiwany)
166
Faza
- Nie dotyczy
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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Ontario
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Hamilton, Ontario, Kanada, L8N 4K7
- Rekrutacyjny
- Mood Disorders Program, St. Joseph's Healthcare Hamilton
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Kontakt:
- Carolina Oremus, MD,PhD(c)
- Numer telefonu: 36326 +1(905) 522-1155
- E-mail: coremus@stjoes.ca
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Kontakt:
- Margaret C McKinnon, PhD,C.Psych.
- Numer telefonu: 36645 +1(905) 522-1155
- E-mail: mmckinno@stjoes.ca
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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
Opis
Inclusion Criteria:
- admitted to the inpatient clinic of the Mood Disorders Program, St. Joseph's Healthcare Hamilton
- with a primary diagnosis of bipolar disorder I or II, or major depressive disorder
- able to speak, read, and understand English.
Exclusion Criteria:
- cut off score on Montreal Cognitive Assessment (MOCA; clinical judgement)
- significant suicidal or homicidal risk
- a medical condition/treatment known to affect the brain
- acquired brain injury.
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
- Główny cel: Badania usług zdrowotnych
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: PIMM/SAM
Partnership in Medication Management (PIMM): The nurse and the attending physician will meet with the patient and ask how s/he administers medication at home (i.e., blister pack).
Initial education session: the nurse will teach the patient about his/her medications, dosage, purpose, when and how to take them.
Nurse and patient will establish reminders to take his/her medication.
Following the education session, patients will be required to notify the nurse when it is time to take their medications, where their medications are, dosage, purpose and side effects.
Self-Administered Medication (SAM): Patients will transition to SAM once the clinical team feels that no further medication changes are required.
SAM is also the model that the participants will follow after discharge.
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The PIMM program will include education to improve patients' knowledge regarding their medication's purpose, dosage, benefits, and side effects.
The program will also include tools like a checklist or alarm clock to remind patients of when and how to take their medication.
Furthermore, the program will contain an interactive listening period where healthcare professionals involved in medication dispensing will listen to patients' concerns, questions and thoughts regarding their medications.
Inne nazwy:
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Brak interwencji: Standard Prescribing Practice(SPP)
Standard prescribing practice (SPP): medication administration will proceed as standard practice.
Patients will not receive a personalized medication training.
The nurse will administer the patient's medications.
However, patients are encouraged to ask any questions regarding his/her medications.Patients will not be provided with any tool to help them to remember when to take their medications.
The nurse will record the patient's knowledge regarding his/her medications.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Medication adherence measured by the Medication Adherence Rating Scale (MARS).
Ramy czasowe: Change from baseline in the Medication Adherence Rating Scale at 2 days before discharge and 1 week, 1 month, 3 months, 6 months and 12 months post-discharge
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Medication adherence measured by the Medication Adherence Rating Scale (MARS).
We will measure medication adherence at baseline and each follow up
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Change from baseline in the Medication Adherence Rating Scale at 2 days before discharge and 1 week, 1 month, 3 months, 6 months and 12 months post-discharge
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Time to re-hospitalization
Ramy czasowe: First time re-hospitalization any point during the 12-month follow-up period
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Investigators will compare the time to re-hospitalization between each study group.
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First time re-hospitalization any point during the 12-month follow-up period
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Costs of re-hospitalization
Ramy czasowe: First time re-hospitalization any point during the 12-month follow-up period
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Investigators will adopt a healthcare system perspective and compare the costs of first re-hospitalization between each study group.
When a participant is re-hospitalized for the first time at any point during the 12-month follow-up period, investigators will conduct a chart review of the entire re-hospitalization to identify all of the direct and indirect medical resources consumed during this re-hospitalization.
The chart review will cover the entire length of the re-hospitalization, even if this length exceeds the 12-month follow-up period for the participant in question.
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First time re-hospitalization any point during the 12-month follow-up period
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Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Carolina Oremus, MD, PhD(c), McMaster University
- Główny śledczy: Sharon Simmons, RN,BScN,CPMHNc, St. Joseph's Healthcare Hamilton
- Główny śledczy: Margaret C McKinnon, PhD,C.Psych., McMaster University
Publikacje i pomocne linki
Osoba odpowiedzialna za wprowadzenie informacji o badaniu dobrowolnie udostępnia te publikacje. Mogą one dotyczyć wszystkiego, co jest związane z badaniem.
Publikacje ogólne
- The World Health Organization.The global burden of disease: 2004 update, Table A2: Burden of disease in DALYs by cause, sex and income group in WHO regions, estimates for 2004. Geneva, Switzerland, 2008 (accessed on: March 6, 2014).
- Health Canada. A Report on Mental Illnesses in Canada. Ottawa: Health Canada, 2002.
- World Health Organization. Adherence to Long- Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization, 2003.
- Rosa AR, Marco M, Fachel JM, Kapczinski F, Stein AT, Barros HM. Correlation between drug treatment adherence and lithium treatment attitudes and knowledge by bipolar patients. Prog Neuropsychopharmacol Biol Psychiatry. 2007 Jan 30;31(1):217-24. doi: 10.1016/j.pnpbp.2006.08.007. Epub 2006 Sep 18.
- Nemeroff CB, Heim CM, Thase ME, Klein DN, Rush AJ, Schatzberg AF, Ninan PT, McCullough JP Jr, Weiss PM, Dunner DL, Rothbaum BO, Kornstein S, Keitner G, Keller MB. Differential responses to psychotherapy versus pharmacotherapy in patients with chronic forms of major depression and childhood trauma. Proc Natl Acad Sci U S A. 2003 Nov 25;100(24):14293-6. doi: 10.1073/pnas.2336126100. Epub 2003 Nov 13. Erratum In: Proc Natl Acad Sci U S A. 2005 Nov 8;102(45):16530.
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
1 stycznia 2015
Zakończenie podstawowe (Oczekiwany)
1 listopada 2016
Ukończenie studiów (Oczekiwany)
1 maja 2017
Daty rejestracji na studia
Pierwszy przesłany
28 października 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 listopada 2014
Pierwszy wysłany (Oszacować)
7 listopada 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
18 listopada 2015
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
17 listopada 2015
Ostatnia weryfikacja
1 listopada 2015
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- PIMM MDP
- PIMM Mood Disorders Program (Inny numer grantu/finansowania: Mood Disorders Program, St. Joseph/s Healthcare Hamilton)
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 .