Recruiting

Observational Study

Sponsor:

St. Joseph's Healthcare Hamilton

Code:

NCT02285608

Conditions

Major Depressive Disorder

Bipolar Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

PIMM/SAM

Study Details

Brief summary:

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.

Conditions

Major Depressive Disorder

Bipolar Disorder

Study ID

NCT02285608

Start date

Jan, 2015

Status verified date

Nov, 2015

Completion date

May, 2017

Anticipated

Primary completion date

Nov, 2016

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

166 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: 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.

no intervention: 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.

Interventions

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.

Primary outcome measure

  • Medication adherence measured by the Medication Adherence Rating Scale (MARS). [ Time Frame: 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 ]

Central Contacts and Locations

Central contacts

Carolina Oremus, MD, PhD(c)

+1(905) 522-1155coremus@stjoes.ca

Margaret C McKinnon, PhD,C.Psych.

+1(905) 522-1155mmckinno@stjoes.ca

Locations

Mood Disorders Program, St. Joseph's Healthcare Hamilton

Recruiting

Hamilton, Ontario, Canada, L8N 4K7

Contacts

Carolina Oremus, MD,PhD(c)

+1(905) 522-1155coremus@stjoes.ca

Margaret C McKinnon, PhD,C.Psych.

+1(905) 522-1155mmckinno@stjoes.ca

More Information

Sponsor

St. Joseph's Healthcare Hamilton

Last update posted

Nov 18, 2015

Last verified

Nov, 2015

Keywords

  • Medication adherence
  • Patient education
  • Mood disorders
  • Economic assessment
  • Mixed methods

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Joseph's Healthcare Hamilton on 2015-11-18.