Clinical trial NCT02285608: Partnership in Medication Management (PIMM) in Patients With Mood Disorders
Official title: Partnership in Medication Management (PIMM): The Effects of One-on-one Medication Training on Medication Adherence in Patients With Mood Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Depressive Disorder
Bipolar Disorder
Keywords: Medication adherence
Patient education
Mood disorders
Economic assessment
Mixed methods
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2014-11-07
Enrollment: 166
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Medication adherence measured by the Medication Adherence Rating Scale (MARS).
timeFrame: 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
Secondary outcomes:
measure: Time to re-hospitalization
timeFrame: First time re-hospitalization any point during the 12-month follow-up period
measure: Costs of re-hospitalization
timeFrame: First time re-hospitalization any point during the 12-month follow-up period
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Mood Disorders Program, St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: McMaster University
name: Carolina Oremus, MD, PhD(c)
role: PRINCIPAL_INVESTIGATOR
affiliation: St. Joseph's Healthcare Hamilton
name: Sharon Simmons, RN,BScN,CPMHNc
role: PRINCIPAL_INVESTIGATOR
affiliation: McMaster University
name: Margaret C McKinnon, PhD,C.Psych.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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).
citation: Health Canada. A Report on Mental Illnesses in Canada. Ottawa: Health Canada, 2002.
citation: World Health Organization. Adherence to Long- Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization, 2003.
citation: 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.
citation: 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.