The ACHIEVA Study of Enhanced Pharmacist Care on Antidepressant Use and Response
Primary Purpose
Depressive Disorder
Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder focused on measuring Depressive disorder, Patient compliance, Antidepressive Agents, Patient education, Community pharmacy services, Counseling
Eligibility 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
Sites / Locations
- EPICORE Centre
Outcomes
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
Full Information
NCT ID
NCT00356655
First Posted
July 24, 2006
Last Updated
April 8, 2022
Sponsor
University of Alberta
Collaborators
Institute of Health Economics, Canada, Dalhousie University
1. Study Identification
Unique Protocol Identification Number
NCT00356655
Brief Title
The ACHIEVA Study of Enhanced Pharmacist Care on Antidepressant Use and Response
Official Title
A COHORT AND INTERVENTION STUDY EVALUATING ANTIDEPRESSANT EPIDEMIOLOGY AND ADHERENCE: The ACHIEVA Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2008
Overall Recruitment Status
Terminated
Why Stopped
Low recruitment
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alberta
Collaborators
Institute of Health Economics, Canada, Dalhousie University
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
Keywords
Depressive disorder, Patient compliance, Antidepressive Agents, Patient education, Community pharmacy services, Counseling
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Primary Outcome Measure Information:
Title
Persistence
Secondary Outcome Measure Information:
Title
Adherence (mean possession ratio)
Title
Beck Depression Inventory symptom improvement
Title
Beck Anxiety Inventory symptom improvement
Title
Change in antidepressant compliance questionnaire responses
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David M Gardner, PharmD
Organizational Affiliation
Dalhousie University
Official's Role
Principal Investigator
Facility Information:
Facility Name
EPICORE Centre
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
12. IPD Sharing Statement
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The ACHIEVA Study of Enhanced Pharmacist Care on Antidepressant Use and Response
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