Daily Delivery and Supervision of Psychotropic Medication for High-Risk Patients With Severe/Persistent Mental Illness
NCT ID: NCT03766503
Last Updated: 2020-06-23
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
6 participants
INTERVENTIONAL
2016-10-15
2019-02-11
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Deprescribing Antipsychotics in Long-Term Care
NCT02958800
Pharmacogenomic Testing to Optimize Antidepressant Drug Therapy
NCT03591224
Pharmaceutical Care and Quality of Life in Conditions Related to Psychotropic Drug Use
NCT06889636
Reducing Post-discharge Adverse Drug Events Amongst the Elderly: a Multi-centre Electronic Deprescribing Intervention
NCT03272607
The ACHIEVA Study of Enhanced Pharmacist Care on Antidepressant Use and Response
NCT00356655
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
The primary purpose of this study is to evaluate the effectiveness of this new model for decreasing the harmful effects of relapses to psychosis resulting from non-adherence to medications. Specifically, the investigators plan to examine whether or not this program results in less use of crisis services, acute care hospitalization and less contact with the criminal justice system. The investigators plan to evaluate client response through a self-reported measure and to assess client satisfaction by conducting participant satisfaction survey for the program. Key stakeholders will be engaged during the process (e.g., community mental health workers, probation officers, pharmacists) to gather information and suggestions regarding the daily dispensing program. Based on feedback from clients and stakeholders, the investigators will then aim to implement improvements to the process to optimize its effectiveness.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intervention
The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.
Daily
The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Daily
The main study intervention is the daily witnessing of participants while they self-administer their medications by trained pharmacy staff to ensure compliance. The staff in question will be provided by Leila pharmacy and will in addition provide support so that individuals can transition back into living independently through reminders to attend regularly scheduled medical appointments and counseling on correct use of prescribed medications.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Individuals with severe and persistent mental illnesses
* Individuals who have been repeatedly hospitalized, are repeat users of community crisis services, or are in frequently in contact with the criminal justice system
* Individuals who are involved in the Forensics program.
Exclusion Criteria
* Individuals who are part of the daily dispensing program, but are not Forensic outpatients
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Winnipeg Regional Health Authority
OTHER
University of Manitoba
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jeffrey Waldman, MD
Role: PRINCIPAL_INVESTIGATOR
University of Manitoba
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Manitoba
Winnipeg, , Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Emsley R, Oosthuizen P, Koen L, Niehaus D, Martinez L. Comparison of treatment response in second-episode versus first-episode schizophrenia. J Clin Psychopharmacol. 2013 Feb;33(1):80-3. doi: 10.1097/JCP.0b013e31827bfcc1.
Goeree R, Farahati F, Burke N, Blackhouse G, O'Reilly D, Pyne J, Tarride JE. The economic burden of schizophrenia in Canada in 2004. Curr Med Res Opin. 2005 Dec;21(12):2017-28. doi: 10.1185/030079905X75087.
Keers R, Ullrich S, Destavola BL, Coid JW. Association of violence with emergence of persecutory delusions in untreated schizophrenia. Am J Psychiatry. 2014 Mar;171(3):332-9. doi: 10.1176/appi.ajp.2013.13010134.
Patel MX, de Zoysa N, Bernadt M, Bindman J, David AS. Are depot antipsychotics more coercive than tablets? The patient's perspective. J Psychopharmacol. 2010 Oct;24(10):1483-9. doi: 10.1177/0269881109103133. Epub 2009 Mar 20.
Patel MX, de Zoysa N, Bernadt M, David AS. A cross-sectional study of patients' perspectives on adherence to antipsychotic medication: depot versus oral. J Clin Psychiatry. 2008 Oct;69(10):1548-56. doi: 10.4088/jcp.v69n1004. Epub 2008 Sep 23.
Rossler W, Salize HJ, van Os J, Riecher-Rossler A. Size of burden of schizophrenia and psychotic disorders. Eur Neuropsychopharmacol. 2005 Aug;15(4):399-409. doi: 10.1016/j.euroneuro.2005.04.009.
Schooler NR. Relapse prevention and recovery in the treatment of schizophrenia. J Clin Psychiatry. 2006;67 Suppl 5:19-23.
Thornicroft G, Brohan E, Rose D, Sartorius N, Leese M; INDIGO Study Group. Global pattern of experienced and anticipated discrimination against people with schizophrenia: a cross-sectional survey. Lancet. 2009 Jan 31;373(9661):408-15. doi: 10.1016/S0140-6736(08)61817-6. Epub 2009 Jan 21.
Angermeyer MC, Matschinger H. The stereotype of schizophrenia and its impact on discrimination against people with schizophrenia: results from a representative survey in Germany. Schizophr Bull. 2004;30(4):1049-61. doi: 10.1093/oxfordjournals.schbul.a007120.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
H2016:321
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.