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

Not Applicable

Active, not recruiting

• Conditions: Mental Health Services

• Registration Number: NCT06889636
• Lead Sponsor: University of Rijeka

Brief Summary

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

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 Timeline

• Study Start: 2021-12-01
• Status Verified: 2025-02
• Primary Completion: 2025-02-14
• Study First Submitted: 2025-02-25
• Study First Submitted QC: 2025-03-19
• Last Update Submitted: 2025-03-19
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Completion: 2025-04

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 97

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Assessment of the quality of life in subjects using psycholeptics and psychoanaleptics	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.

Secondary Outcome Measures

Name	Time	Method
Analysis of identified drug-related problems	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.

Trial Locations

Locations (1)

Pharmacy Bobanovic Vujnovic Pula; 🇭🇷 Pula, Croatia