NCT06889636

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
97

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2021

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 14, 2025

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

February 25, 2025

Completed
24 days until next milestone

First Posted

Study publicly available on registry

March 21, 2025

Completed
11 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2025

Completed
Last Updated

March 21, 2025

Status Verified

February 1, 2025

Enrollment Period

3.2 years

First QC Date

February 25, 2025

Last Update Submit

March 19, 2025

Conditions

Mental Health Services

Keywords

Mental disordersQuality of lifeDrug-related problems

Outcome Measures

Primary Outcomes (1)

  • Assessment of the quality of life in subjects using psycholeptics and psychoanaleptics

    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 Outcomes (1)

  • Analysis of identified drug-related problems

    During period of three months.

Study Arms (2)

Standardized pharmaceutical care

EXPERIMENTAL

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..

Basic counseling

ACTIVE COMPARATOR

Participants enrolled in group B received pharmaceutical care based on common pharmacist´s practice in Croatia.

Other: Common pharmacists' practice in Croatia.

Interventions

Pharmaceutical care in solving drug-related problems in subjects using psychotropic medicines based on standardized protocol..OTHER

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.

Standardized pharmaceutical care
Common pharmacists' practice in Croatia.OTHER

Group B participants received pharmaceutical care based on common pharmacists' practice in Croatia during the dispensing of psychotropic drugs.

Basic counseling

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pharmacy Bobanovic Vujnovic Pula

Pula, 52100, Croatia

Location

MeSH Terms

Conditions

Mental Disorders

Interventions

Pharmaceutical Services

Intervention Hierarchy (Ancestors)

Health ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assessment of the impact of pharmaceutical care on the quality of life in conditions related to psychotropic drug use and evaluation of the intervention

Study Record Dates

First Submitted

February 25, 2025

First Posted

March 21, 2025

Study Start

December 1, 2021

Primary Completion

February 14, 2025

Study Completion

April 1, 2025

Last Updated

March 21, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations

CR(1)