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

NCT ID: NCT06889636

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

97 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2025-04-30

Brief Summary

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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

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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.

Conditions

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Mental Health Services

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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Standardized pharmaceutical care

Participants in group A received pharmacists' interventions based on standardized Medication Review (MR) and Medication Therapy Management (MTM) protocols.

Group Type EXPERIMENTAL

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

Intervention Type 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.

Basic counseling

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

Group Type ACTIVE_COMPARATOR

Common pharmacists' practice in Croatia.

Intervention Type OTHER

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

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Rijeka

OTHER

Sponsor Role lead

Responsible Party

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Alena Tatarevic

Assessment of the impact of pharmaceutical care on the quality of life in conditions related to psychotropic drug use and evaluation of the intervention

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Pharmacy Bobanovic Vujnovic Pula

Pula, , Croatia

Site Status

Countries

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Croatia

Other Identifiers

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200-07/2023-01/1_001/2023

Identifier Type: -

Identifier Source: org_study_id

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