Partnership in Medication Management (PIMM) in Patients With Mood Disorders
NCT ID: NCT02285608
Last Updated: 2015-11-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
166 participants
INTERVENTIONAL
2015-01-31
2017-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* with a primary diagnosis of bipolar disorder I or II, or major depressive disorder
* able to speak, read, and understand English.
Exclusion Criteria
* significant suicidal or homicidal risk
* a medical condition/treatment known to affect the brain
* acquired brain injury.
18 Years
ALL
No
Sponsors
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St. Joseph's Healthcare Hamilton
OTHER
Responsible Party
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Principal Investigators
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Carolina Oremus, MD, PhD(c)
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Sharon Simmons, RN,BScN,CPMHNc
Role: PRINCIPAL_INVESTIGATOR
St. Joseph's Healthcare Hamilton
Margaret C McKinnon, PhD,C.Psych.
Role: PRINCIPAL_INVESTIGATOR
McMaster University
Locations
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Mood Disorders Program, St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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PIMM Mood Disorders Program
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PIMM MDP
Identifier Type: -
Identifier Source: org_study_id