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Partnership in Medication Management (PIMM) in Patients With Mood Disorders (PIMM)

17 novembre 2015 aggiornato da: 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.

Panoramica dello studio

Stato

Sconosciuto

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Anticipato)

166

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

  • Nome: Carolina Oremus, MD, PhD(c)
  • Numero di telefono: 36326 +1(905) 522-1155
  • Email: coremus@stjoes.ca

Backup dei contatti dello studio

  • Nome: Margaret C McKinnon, PhD,C.Psych.
  • Numero di telefono: 35438 +1(905) 522-1155
  • Email: mmckinno@stjoes.ca

Luoghi di studio

  • Canada
    • Ontario
      • Hamilton, Ontario, Canada, L8N 4K7
        • Reclutamento
        • Mood Disorders Program, St. Joseph's Healthcare Hamilton
        • Contatto:
          • Carolina Oremus, MD,PhD(c)
          • Numero di telefono: 36326 +1(905) 522-1155
          • Email: coremus@stjoes.ca
        • Contatto:
          • Margaret C McKinnon, PhD,C.Psych.
          • Numero di telefono: 36645 +1(905) 522-1155
          • Email: mmckinno@stjoes.ca

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Altro: PIMM/SAM
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.
Altri nomi:
  • Partnership in Medication Management
Nessun intervento: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Medication adherence measured by the Medication Adherence Rating Scale (MARS).
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Time to re-hospitalization
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

St. Joseph's Healthcare Hamilton

Investigatori

  • Investigatore principale: Carolina Oremus, MD, PhD(c), McMaster University
  • Investigatore principale: Sharon Simmons, RN,BScN,CPMHNc, St. Joseph's Healthcare Hamilton
  • Investigatore principale: Margaret C McKinnon, PhD,C.Psych., McMaster University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 gennaio 2015

Completamento primario (Anticipato)

1 novembre 2016

Completamento dello studio (Anticipato)

1 maggio 2017

Date di iscrizione allo studio

Primo inviato

28 ottobre 2014

Primo inviato che soddisfa i criteri di controllo qualità

6 novembre 2014

Primo Inserito (Stima)

7 novembre 2014

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

18 novembre 2015

Ultimo aggiornamento inviato che soddisfa i criteri QC

17 novembre 2015

Ultimo verificato

1 novembre 2015

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • PIMM MDP
  • PIMM Mood Disorders Program (Altro numero di sovvenzione/finanziamento: Mood Disorders Program, St. Joseph/s Healthcare Hamilton)

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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