Pharmaceutical Care and Quality of Life in Conditions Related to Psychotropic Drug Use

March 19, 2025 updated by: Alena Tatarevic, University of Rijeka

Assessment of the Impact of Pharmaceutical Care on the Quality of Life in Conditions Related to Psychotropic Drug Use and Evaluation of the Intervention

This study aims to assess and describe the impact of pharmaceutical care on identified drug-related problems (DRPs) in subjects using psycholeptics and psychoanaleptics in primary care, improving subjects' self-assessed quality of life (QoL)

The hypothesis of the study are:

  1. Side-effects are the most common DRPs in subjects using psychotropic medicines in primary care,
  2. Treatment effectiveness and safety affect the subjects´ QoL

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

The study objectives are to:

  1. assess QoL in subjects using psycholeptics and psychoanaleptics,
  2. analyze identified DRPs and their causes in subjects using psycholeptics and psychoanaleptics
  3. evaluate the correlation between the type and total number of DRPs identified in a single subject with QoL,
  4. describe the impact of pharmacists´ intervention in the identification and resolution of the DRPs and their causes on subjects´ QoL.

Study Type

Interventional

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Pula, Croatia, 52100
        • Pharmacy Bobanovic Vujnovic Pula

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult participants (years 18+)
  • Usage of psycholeptic or psychoanaleptic medicines
  • Residence in Istrian County (Croatia)

Exclusion Criteria:

  • Minor participants
  • Hospitalization during study participation
  • Unable to live by themselves
  • Unable to participate in study for 3 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Standardized pharmaceutical care
Participants in group A received pharmacists' interventions based on standardized Medication Review (MR) and Medication Therapy Management (MTM) protocols.
Other: Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol..
Pharmacists' interventions were based on Medication Review and Medication Therapy Management evaluations of a subjects' pharmacotherapy to optimize medicine use, improve treatment outcomes and quality of life. The intervention involved the identification of drug-related problems and addressing these issues through pharmacist interventions. The intervention was based on information gathered from the subjects and a list of medicines in use.
Active Comparator: Basic counseling
Participants enrolled in group B received pharmaceutical care based on common pharmacist´s practice in Croatia.
Other: Common pharmacists' practice in Croatia.
Group B participants received pharmaceutical care based on common pharmacists' practice in Croatia during the dispensing of psychotropic drugs.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of the quality of life in subjects using psycholeptics and psychoanaleptics
Time Frame: Prior and after the pharmacists' intervention during three months period.
A short version of the World Health Organization's quality of life questionnaire (WHOQOL-BREF questionnaire) is being used to assess subjects' QoL. The scale range is from 0 to 100. A higher score number indicates better QoL.
Prior and after the pharmacists' intervention during three months period.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Analysis of identified drug-related problems
Time Frame: During period of three months.
To analyze the type of DRPs, validated Classification for Drug-Related Problems from the Pharmaceutical Care Network Europe Association, version 9.1 has been used. PCNE Classification for DRPs describes each type of DRP by unique code.
During period of three months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Rijeka

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2021

Primary Completion (Actual)

February 14, 2025

Study Completion (Estimated)

April 1, 2025

Study Registration Dates

First Submitted

February 25, 2025

First Submitted That Met QC Criteria

March 19, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 19, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 200-07/2023-01/1_001/2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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