NCT02285608

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
166

participants targeted

Target at P75+ for not_applicable major-depressive-disorder

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 28, 2014

Completed
10 days until next milestone

First Posted

Study publicly available on registry

November 7, 2014

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 18, 2015

Status Verified

November 1, 2015

Enrollment Period

1.8 years

First QC Date

October 28, 2014

Last Update Submit

November 17, 2015

Conditions

Major Depressive DisorderBipolar Disorder

Keywords

Medication adherencePatient educationMood disordersEconomic assessmentMixed methods

Outcome Measures

Primary Outcomes (1)

  • Medication adherence measured by the Medication Adherence Rating Scale (MARS).

    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

Secondary Outcomes (2)

  • Time to re-hospitalization

    First time re-hospitalization any point during the 12-month follow-up period

  • Costs of re-hospitalization

    First time re-hospitalization any point during the 12-month follow-up period

Study Arms (2)

PIMM/SAM

EXPERIMENTAL

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.

Other: PIMM/SAM

Standard Prescribing Practice(SPP)

NO 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.

Interventions

PIMM/SAMOTHER

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.

Also known as: Partnership in Medication Management
PIMM/SAM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mood Disorders Program, St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4K7, Canada

RECRUITING

Related Publications (5)

  • 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).

    BACKGROUND

  • Health Canada. A Report on Mental Illnesses in Canada. Ottawa: Health Canada, 2002.

    BACKGROUND

  • World Health Organization. Adherence to Long- Term Therapies: Evidence for Action. Geneva, Switzerland: World Health Organization, 2003.

    BACKGROUND

  • 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.

    PMID: 16982121BACKGROUND

  • 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.

    PMID: 14615578BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorBipolar DisorderMedication AdherenceMood Disorders

Condition Hierarchy (Ancestors)

Depressive DisorderMental DisordersBipolar and Related DisordersPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Carolina Oremus, MD, PhD(c)

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Sharon Simmons, RN,BScN,CPMHNc

    St. Joseph's Healthcare Hamilton

    PRINCIPAL INVESTIGATOR

  • Margaret C McKinnon, PhD,C.Psych.

    McMaster University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Carolina Oremus, MD, PhD(c)

CONTACT

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

Margaret C McKinnon, PhD,C.Psych.

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 28, 2014

First Posted

November 7, 2014

Study Start

January 1, 2015

Primary Completion

November 1, 2016

Study Completion

May 1, 2017

Last Updated

November 18, 2015

Record last verified: 2015-11

Locations

CA(1)