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Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care (PRODEFAR)

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pharmaceutical care program for antidepressant treatment
Sponsored by
Fundació Sant Joan de Déu
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Medication adherence, Antidepressive agents, Primary care, Pharmaceutical care

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Clinical diagnosis for depression from a general practitioner
  • Beginning a pharmacological antidepressant treatment
  • Going to one of the participant community pharmacies

Exclusion Criteria:

  • Used antidepressant medication in the past 2 months
  • Had an appointment with an specialist in mental disorders in the past 2 months
  • History of psychotic or bipolar episodes
  • History of drug abuse or dependency
  • Cognitive impairment that not allows assessment

Sites / Locations

  • Primary Care Center Gavà 1
  • Primary Care Center Doctor Bartomeu Fabres Anglada

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual Care

Intervention Group

Arm Description

The control group will be receiving usual medical and pharmaceutical care.

Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.

Outcomes

Primary Outcome Measures

Adherence to Antidepressant Medication
Adherence to antidepressant medication was measured through Pharmacy records

Secondary Outcome Measures

Patient Wellbeing
Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life. The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health.

Full Information

First Posted
November 17, 2008
Last Updated
October 1, 2016
Sponsor
Fundació Sant Joan de Déu
Collaborators
Carlos III Health Institute, Catalan Institute of Health, University of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT00794196
Brief Title
Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care
Acronym
PRODEFAR
Official Title
Impact of the Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care on the Compliance to Antidepressants and Patient Wellbeing
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundació Sant Joan de Déu
Collaborators
Carlos III Health Institute, Catalan Institute of Health, University of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the impact of pharmaceutical services among patients starting a treatment with antidepressants for a diagnosis of depression. The hypothesis of the study is that pharmacist intervention can improve compliance to antidepressants and patient wellbeing.
Detailed Description
The aim of this study is to evaluate the efficacy of a support program in community pharmacy on the improvement of the compliance to antidepressants and the clinic of typical primary care patients under normal practice circumstances. That implies that the intervention is made by pharmacists without any specific requirement that work in the community pharmacies set up in the area of study and on patients following the usual medical circuit. As well, the cost of the support program is calculated in order to set the effectiveness of the program.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Medication adherence, Antidepressive agents, Primary care, Pharmaceutical care

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
179 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
The control group will be receiving usual medical and pharmaceutical care.
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Intervention group will be receiving usual medical and pharmaceutical care plus a pharmaceutical support program.
Intervention Type
Behavioral
Intervention Name(s)
Pharmaceutical care program for antidepressant treatment
Other Intervention Name(s)
PRODEFAR group
Intervention Description
The pharmaceutical care program is a support program for patients starting and maintaining antidepressant treatment.
Primary Outcome Measure Information:
Title
Adherence to Antidepressant Medication
Description
Adherence to antidepressant medication was measured through Pharmacy records
Time Frame
At 3 and 6 months
Secondary Outcome Measure Information:
Title
Patient Wellbeing
Description
Patient wellbeing EUROQOL5D scale is used to evaluate health-related quality of life. The answers given to EUROQOL5D allow for the description 243 unique health states which can be converted into EQ-5D index anchored at 0 for death and 1 for perfect health.
Time Frame
0, 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis for depression from a general practitioner Beginning a pharmacological antidepressant treatment Going to one of the participant community pharmacies Exclusion Criteria: Used antidepressant medication in the past 2 months Had an appointment with an specialist in mental disorders in the past 2 months History of psychotic or bipolar episodes History of drug abuse or dependency Cognitive impairment that not allows assessment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Antoni Serrano, MD PhD
Organizational Affiliation
Foundation Sant Joan de Deu
Official's Role
Principal Investigator
Facility Information:
Facility Name
Primary Care Center Gavà 1
City
Gava
State/Province
Barcelona
ZIP/Postal Code
08850
Country
Spain
Facility Name
Primary Care Center Doctor Bartomeu Fabres Anglada
City
Gavà
State/Province
Barcelona
ZIP/Postal Code
08850
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
23950967
Citation
Rubio-Valera M, Bosmans J, Fernandez A, Penarrubia-Maria M, March M, Trave P, Bellon JA, Serrano-Blanco A. Cost-effectiveness of a community pharmacist intervention in patients with depression: a randomized controlled trial (PRODEFAR Study). PLoS One. 2013 Aug 12;8(8):e70588. doi: 10.1371/journal.pone.0070588. eCollection 2013. Erratum In: PLoS One. 2016;11(1):e0147459.
Results Reference
derived
PubMed Identifier
19656386
Citation
Rubio-Valera M, Serrano-Blanco A, Trave P, Penarrubia-Maria MT, Ruiz M, Pujol MM. Community pharmacist intervention in depressed primary care patients (PRODEFAR study): randomized controlled trial protocol. BMC Public Health. 2009 Aug 5;9:284. doi: 10.1186/1471-2458-9-284.
Results Reference
derived

Learn more about this trial

Pharmaceutical Care Program for Pharmacological Treatment of Depression in Primary Care

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