The ACHIEVA Study of Enhanced Pharmacist Care on Antidepressant Use and Response

This study has been terminated.
(Low recruitment)
Sponsor:
Collaborators:
Institute of Health Economics, Canada
Dalhousie University
Information provided by:
University of Alberta
ClinicalTrials.gov Identifier:
NCT00356655
First received: July 24, 2006
Last updated: May 12, 2008
Last verified: May 2008
  Purpose

This a comparative study of enhanced pharmacist care and regular care of patients starting on antidepressants. When providing participants with enhanced care pharmacists will use the Health Professional's Antidepressant Communications Tool (Health PACT) a minimum of three times during face-to-face discussions. This tool was developed specifically for this study. All participants will be followed for 26 weeks and will be assessed for duration of use of their antidepressant, adherence to treatment, and clinical response.


Condition Intervention
Depressive Disorder
Behavioral: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A COHORT AND INTERVENTION STUDY EVALUATING ANTIDEPRESSANT EPIDEMIOLOGY AND ADHERENCE: The ACHIEVA Study

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • Persistence

Secondary Outcome Measures:
  • Adherence (mean possession ratio)
  • Beck Depression Inventory symptom improvement
  • Beck Anxiety Inventory symptom improvement
  • Change in antidepressant compliance questionnaire responses

Estimated Enrollment: 106
Study Start Date: July 2006
Estimated Study Completion Date: January 2009
Detailed Description:

This proposal describes a combined observational study (Phase I) and randomized controlled trial (Phase II). The primary aim of the observational study is to determine the disorders, in particular the types of depression, for which family physicians prescribe antidepressants. The primary aim of the randomized controlled trial (RCT) is to compare the effect of a brief psycho-educational intervention by pharmacists with usual care on antidepressant persistence.

Subjects (n=621 phase 1, n=106 phase 2) will be patients presenting to a pharmacy in Edmonton with a prescription for an antidepressant from a family physician and meeting the following criteria: no antidepressants taken in the preceding six months; 18 years of age or older, and fluent in English. Subjects will be interviewed using modified versions of the depression, generalized anxiety disorder and panic disorder sections of the Diagnostic Interview Schedule; the Beck Depression Inventory; the Beck Anxiety Inventory; and a question on recent stressful life events. For Phase 1 the proportion of subjects with the following DSM-IV diagnoses will be estimated: major depression, "minor depression," generalized anxiety disorder, panic disorder; minor depression will be categorized into "adjustment disorder with depressed mood" and "adjustment disorder with mixed anxiety and depressed mood". The family doctor will be contacted and asked for the diagnosis that prompted the antidepressant prescription.

Subjects with DSM IV depression will be invited to participate in Phase 2. Individuals will be randomized to a pharmacist intervention with the Health PACT, or to usual care. Using the newly-developed Antidepressant Compliance Questionnaire, information on predictors of adherence will be collected at the baseline interview. At weeks 4, 8, 16 and 26, subjects will be contacted by phone and questioned on antidepressant adherence and persistence. At week 8 (or the exit interview if a subject leaves the study early), we will administer the Beck Depression Inventory and the Beck Anxiety Inventory. The primary outcome is treatment persistence, defined as the time to stop antidepressant use. Adherence, defined by the medication possession ratio (MPR), will be also be measured.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient presents to a pharmacy with a prescription for an antidepressant from a family physician
  • patient with DSM-IV major or minor depression
  • patient has not taken an antidepressant in the preceding six months
  • patient is 18 years of age or older
  • patient is fluent in English
  • patient taking newly-prescribed antidepressant for no more than 1 week

Exclusion Criteria:

  • patient with plans of leaving the vicinity within 6 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00356655

Locations
Canada, Alberta
EPICORE Centre
Edmonton, Alberta, Canada, T6G 2C8
Sponsors and Collaborators
University of Alberta
Institute of Health Economics, Canada
Dalhousie University
Investigators
Principal Investigator: David M Gardner, PharmD Dalhousie University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00356655     History of Changes
Other Study ID Numbers: 1-Gardner
Study First Received: July 24, 2006
Last Updated: May 12, 2008
Health Authority: Canada: Health Canada

Keywords provided by University of Alberta:
Depressive disorder
Patient compliance
Antidepressive Agents
Patient education
Community pharmacy services
Counseling

Additional relevant MeSH terms:
Depressive Disorder
Depression
Mood Disorders
Mental Disorders
Behavioral Symptoms
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014