Partnership in Medication Management (PIMM) in Patients With Mood Disorders (PIMM)
17 november 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Onbekend
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Verwacht)
166
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
Ontario
-
Hamilton, Ontario, Canada, L8N 4K7
- Werving
- Mood Disorders Program, St. Joseph's Healthcare Hamilton
-
Contact:
- Carolina Oremus, MD,PhD(c)
- Telefoonnummer: 36326 +1(905) 522-1155
- E-mail: coremus@stjoes.ca
-
Contact:
- Margaret C McKinnon, PhD,C.Psych.
- Telefoonnummer: 36645 +1(905) 522-1155
- E-mail: mmckinno@stjoes.ca
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
18 jaar en ouder (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
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.
Andere namen:
|
|
Geen tussenkomst: 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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Medication adherence measured by the Medication Adherence Rating Scale (MARS).
Tijdsspanne: 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
|
Medication adherence measured by the Medication Adherence Rating Scale (MARS).
We will measure medication adherence at baseline and each follow up
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Time to re-hospitalization
Tijdsspanne: First time re-hospitalization any point during the 12-month follow-up period
|
Investigators will compare the time to re-hospitalization between each study group.
|
First time re-hospitalization any point during the 12-month follow-up period
|
|
Costs of re-hospitalization
Tijdsspanne: First time re-hospitalization any point during the 12-month follow-up period
|
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.
|
First time re-hospitalization any point during the 12-month follow-up period
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Hoofdonderzoeker: Carolina Oremus, MD, PhD(c), McMaster University
- Hoofdonderzoeker: Sharon Simmons, RN,BScN,CPMHNc, St. Joseph's Healthcare Hamilton
- Hoofdonderzoeker: Margaret C McKinnon, PhD,C.Psych., McMaster University
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 januari 2015
Primaire voltooiing (Verwacht)
1 november 2016
Studie voltooiing (Verwacht)
1 mei 2017
Studieregistratiedata
Eerst ingediend
28 oktober 2014
Eerst ingediend dat voldeed aan de QC-criteria
6 november 2014
Eerst geplaatst (Schatting)
7 november 2014
Updates van studierecords
Laatste update geplaatst (Schatting)
18 november 2015
Laatste update ingediend die voldeed aan QC-criteria
17 november 2015
Laatst geverifieerd
1 november 2015
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- PIMM MDP
- PIMM Mood Disorders Program (Ander subsidie-/financieringsnummer: Mood Disorders Program, St. Joseph/s Healthcare Hamilton)
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .