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PIMM/SAM for Bipolar Disorder (PIMM Trial)
N/A
Waitlist Available
Led By Carolina Oremus, MD, PhD(c)
Research Sponsored by St. Joseph's Healthcare Hamilton
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up first time re-hospitalization any point during the 12-month follow-up period
Awards & highlights
PIMM Trial 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.
Eligible Conditions
- Bipolar Disorder
- Depression
PIMM Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ first time re-hospitalization any point during the 12-month follow-up period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~first time re-hospitalization any point during the 12-month follow-up period
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Medication adherence measured by the Medication Adherence Rating Scale (MARS).
Secondary outcome measures
Costs of re-hospitalization
Time to re-hospitalization
PIMM Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: PIMM/SAMExperimental Treatment1 Intervention
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.
Group II: Standard Prescribing Practice(SPP)Active Control1 Intervention
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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Who is running the clinical trial?
St. Joseph's Healthcare HamiltonLead Sponsor
196 Previous Clinical Trials
25,378 Total Patients Enrolled
4 Trials studying Bipolar Disorder
268 Patients Enrolled for Bipolar Disorder
Carolina Oremus, MD, PhD(c)Principal InvestigatorMcMaster University
Sharon Simmons, RN,BScN,CPMHNcPrincipal InvestigatorSt. Joseph's Healthcare Hamilton
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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